ObesityADIPOSTRESSNCT01559415
An Adipocyte-Driven Mechanism For Weight Regain After Weight Loss: The Yo-Yo Effect
A study testing Meal replacement diet using Modifast and Normal diet combined with Modifast diet in people with Obesity and Weight Loss, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Almost half of the Dutch population is currently characterized by overweight and obesity. Losing weight is not the problem in obesity treatment, it is the seemingly obligatory weight regain after weight loss: the yoyo-effect. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Obesity, Weight Loss, Diet
- What is being tested?
- Meal replacement diet using Modifast and Normal diet combined with Modifast diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2012to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age (years): 20-65
- Body Mass Index (kg/m2): 28-35
- Non-smokers
Who cannot join
- Subjects using prescription medication, or suffering from diseases or conditions that might influence the outcome of the study: this concerns diseases/medication that influence body weight regulation (malabsorption, untreated hypo/hyperthyroidism, eating disorders, systemic use of steroids, etc.) and obesity-related cardiovascular risk factors (heart disease, systolic and diastolic blood pressures > 160/100 mmHg, blood glucose > 6.1 mmol L-1, blood cholesterol > 7 mmol L-1, blood triglycerides > 3 mmol L-1)
- marked alcohol consumption > 21 alcoholic units week-1 (male), or >14 alcoholic units week-1 (female)
- planned major changes in physical activity during the study to an extent that might interfere with the study outcome as judged by the investigator;
- blood donation within the past 2 months prior to the study
- weight change of >3 kg within 2 months prior to the study
- psychiatric disease (based on medical history only)
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- pregnant or lactating women, or women planning to become pregnant within the next 12 months
- surgically treated obesity
- participation in other clinical studies within the last 3 months
- drug abuse (based on clinical judgment)
- unable to give informed consent
- unable to engage in a low-calorie diet
- unable to lose more then 8% of body weight after weight-loss period
- following a special diet (vegetarian, Atkins or other).
Trial locations and contacts
1 site in 1 country.
About this study
Almost half of the Dutch population is currently characterized by overweight and obesity. Losing weight is not the problem in obesity treatment, it is the seemingly obligatory weight regain after weight loss: the yoyo-effect. The primary objective of this study is to investigate the association between the weight-loss-induced cellular stress response and the rate of weight regain. The secondary objective is to investigate the differences in cellular stress response and weight regain after rapid and slow weight loss. To investigate this, subjects will receive meal replacements replacing either all or part of the daily meals during the intervention period. THe first group will consume 500 kcal/d diet for 5 weeks while the second group consumes a 1250 kcal/d diet for 3 months, both followed by 1 week normalization and a 2 week strict weight maintenance diet. During the 9-month follow-up period subjects will receive dietary advice according to the Dutch recommendations for healthy eating. The association between the amount of weight regain after the weight loss period and changes in adipokines, parameters of adipocyte metabolism, in vivo adipose tissue metabolism, adipocyte extracellular matrix gene expression profiles, adipocyte stress protein expression and gene polymorphisms in selected genes.
- Conditions
- Obesity, Weight Loss, Diet
- Being tested
- Meal replacement diet using Modifast, Normal diet combined with Modifast diet
- Keywords
- Adipocytes
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal replacement diet using ModifastOther
modifast intensive diet replacing all regular meals (500 kcal/d) for 5 weeks
Normal diet combined with Modifast dietOther
Combination of modifast and regular diet (1250 kcal/d) for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Very Low Calorie Diet | Experimental | Not described Receives: Other: Meal replacement diet using Modifast |
| Low Calorie Diet | Active comparator | 1250 kcal diet in which Modifast is given in combination with a normal diet Receives: Other: Normal diet combined with Modifast diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in weight following weight loss
VLCD diet group
Measured: at 9 weeks and at 46 weeks
change in weight following weight loss
LCD diet group
Measured: at 16 weeks and at 53 weeks
Secondary outcomes (88)
change in adipokine profile due to dietary intervention (VLCD-group)
In VLCD-group.
Parameters of adipokine profile, including:
leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa
Measured: at baseline and after 5 weeks of VLCD diet
change in adipokine during weight stable-period (VLCD-group)
In VLCD-group.
Parameters of adipokine profile, including:
leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa
Measured: after 5 weeks of VLCD diet and after 9 weeks
change in adipokine profile during follow-up (VLCD-group)
In VLCD-group.
Parameters of adipokine profile, including:
leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa
Measured: at 9 weeks and after follow-up at 46 weeks
change in adipokine profile due to dietary intervention (LCD-group)
In LCD-group.
Parameters of adipokine profile, including:
leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa
Measured: at baseline and after 12 weeks of LCD diet
change in adipokine profile during weight-stable period (LCD-group)
In LCD-group.
Parameters of adipokine profile, including:
leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa
Measured: after 12 weeks of LCD diet and at 16 weeks
change in adipokine profile during follow-up (LCD-group)
In LCD-group.
Parameters of adipokine profile, including:
leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa
Measured: at 16 weeks and after follow-up at 53 weeks
Changes in adipokine profile in the LCD-group compared to the VLCD-group
In LCD-group.
Parameters of adipokine profile, including:
leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa
Measured: at baseline, at 5, 9, 12, 16, 46 and 53 weeks
change in adipokine profile in relation to weight regain during follow-up
In LCD-group and VLCD-group
Parameters of adipokine profile, including:
leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa
Measured: at baseline, at 5, 9, 12, 16, 46 and 53 weeks
change in parameters of adipocyte fat metabolism due to dietary intervention (VLCD-group)
In VLCD-group.
Parameters of adipocyte fat metabolism:
- ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
- Micro-array analysis of gene expression profile
Measured: at baseline and after 5 weeks of VLCD diet
change in parameters of adipocyte fat metabolism during weight-stable period (VLCD-group)
In VLCD-group.
Parameters of adipocyte fat metabolism:
- ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
- Micro-array analysis of gene expression profile
Measured: after 5 weeks of VLCD diet and at 9 weeks
change in parameters of adipocyte fat metabolism during follow-up period (VLCD-group)
In VLCD-group.
Parameters of adipocyte fat metabolism:
- ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
- Micro-array analysis of gene expression profile
Measured: at 9 weeks and after follow-up at 46 weeks
change in parameters of adipocyte fat metabolism due to dietary intervention (LCD-group)
In LCD-group.
Parameters of adipocyte fat metabolism:
- ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
- Micro-array analysis of gene expression profile
Measured: at baseline and after 12 weeks of LCD diet
change in parameters of adipocyte fat metabolism during weight-stable period (LCD-group)
In LCD-group.
Parameters of adipocyte fat metabolism:
- ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
- Micro-array analysis of gene expression profile
Measured: after 12 weeks of LCD diet and at 16 weeks
change in parameters of adipocyte fat metabolism during follow-up (LCD-group)
In LCD-group.
Parameters of adipocyte fat metabolism:
- ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
- Micro-array analysis of gene expression profile
Measured: at 16 weeks and after follow-up at 53 weeks
Changes in parameters of adipocyte fat metabolism in the LCD-group compared to the VLCD-group
Parameters of adipocyte fat metabolism:
- ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
- Micro-array analysis of gene expression profile
Measured: at baseline, at 5, 9, 12, 16, 46 and 53 weeks
change in parameters of adipocyte fat metabolism in relation to weight regain during follow-up
In LCD-group and VLCD-group.
Parameters of adipocyte fat metabolism:
- ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
- Micro-array analysis of gene expression profile
Measured: at baseline, at 5, 9, 12, 16, 46 and 53 weeks
change in in-vivo adipose tissue metabolism due to dietary intervention (VLCD-group)
In VLCD-group.
In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:
- adipose tissue blood flow
- adipose tissue PO2
- adipose tissue oxygen consumption
- adipose tissue capacity for fat uptake from chylomicron-triglycerides
Measured: at baseline and after 5 weeks of VLCD diet
change in in-vivo adipose tissue metabolism during weight-stable period (VLCD-group)
In VLCD-group.
In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:
- adipose tissue blood flow
- adipose tissue PO2
- adipose tissue oxygen consumption
- adipose tissue capacity for fat uptake from chylomicron-triglycerides
Measured: after 5 weeks of VLCD diet and at 9 weeks
change in in-vivo adipose tissue metabolism during follow-up period (VLCD-group)
In VLCD-group.
In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:
- adipose tissue blood flow
- adipose tissue PO2
- adipose tissue oxygen consumption
- adipose tissue capacity for fat uptake from chylomicron-triglycerides
Measured: at 9 weeks and after follow-up period at 46 weeks
change in in-vivo adipose tissue metabolism due to dietary intervention (LCD-group)
In LCD-group.
In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:
- adipose tissue blood flow
- adipose tissue PO2
- adipose tissue oxygen consumption
- adipose tissue capacity for fat uptake from chylomicron-triglycerides
Measured: at baseline and after 12 weeks of LCD diet
change in in-vivo adipose tissue metabolism during weight-stable period (LCD-group)
In LCD-group.
In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:
- adipose tissue blood flow
- adipose tissue PO2
- adipose tissue oxygen consumption
- adipose tissue capacity for fat uptake from chylomicron-triglycerides
Measured: after 12 weeks of LCD diet and at 16 weeks
change in in-vivo adipose tissue metabolism during follow-up period (LCD-group)
In LCD-group.
In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:
- adipose tissue blood flow
- adipose tissue PO2
- adipose tissue oxygen consumption
- adipose tissue capacity for fat uptake from chylomicron-triglycerides
Measured: at 16 weeks and after follow-up period at 53 weeks
change in in-vivo adipose tissue metabolism in the LCD-group compared to the VLCD-group
In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:
- adipose tissue blood flow
- adipose tissue PO2
- adipose tissue oxygen consumption
- adipose tissue capacity for fat uptake from chylomicron-triglycerides
Measured: at baseline, at 5, 9, 12, 16, 46 and 53 weeks
change in in-vivo adipose tissue metabolism in relation to weight regain during follow-up
In LCD-group and VLCD-group
In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:
- adipose tissue blood flow
- adipose tissue PO2
- adipose tissue oxygen consumption
- adipose tissue capacity for fat uptake from chylomicron-triglycerides
Measured: at baseline, at 5, 9, 12, 16, 46 and 53 weeks
change in the adipocyte extracellular matrix gene and protein expression profile due to dietary intervention (VLCD-group)
VLCD diet group
Adipocyte extracellular matrix gene expression profile assessed:
- micro-arrays on RNA expression
- protein expression
- Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9
Measured: at baseline and after 5 weeks of VLCD diet
change in the adipocyte extracellular matrix gene and protein expression profile during weight-stable period (VLCD-group)
VLCD diet group
Adipocyte extracellular matrix gene expression profile assessed:
- micro-arrays on RNA expression
- protein expression
- Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9
Measured: after 5 weeks of VLCD diet and at 9 weeks
change in the adipocyte extracellular matrix gene and protein expression profile during follow-up period (VLCD-group)
VLCD diet group
Adipocyte extracellular matrix gene expression profile assessed:
- micro-arrays on RNA expression
- protein expression
- Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9
Measured: at 9 weeks and after follow-up period at 46 weeks
change in the adipocyte extracellular matrix gene and protein expression profile due to dietary intervention (LCD-group)
LCD diet group
Adipocyte extracellular matrix gene expression profile assessed:
- micro-arrays on RNA expression
- protein expression
- Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9
Measured: at baseline and after 12 weeks of LCD diet
change in the adipocyte extracellular matrix gene and protein expression profile during weight-stable period (LCD-group)
LCD diet group
Adipocyte extracellular matrix gene expression profile assessed:
- micro-arrays on RNA expression
- protein expression
- Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9
Measured: after 12 weeks of LCD diet and at 16 weeks
change in the adipocyte extracellular matrix gene and protein expression profile during follow-up period (LCD-group)
LCD diet group
Adipocyte extracellular matrix gene expression profile assessed:
- micro-arrays on RNA expression
- protein expression
- Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9
Measured: at 16 weeks and after follow-up period
change in the adipocyte extracellular matrix gene and protein expression profile in the LCD-group compared to the VLCD-group
Adipocyte extracellular matrix gene expression profile assessed:
- micro-arrays on RNA expression
- protein expression
- Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9
Measured: at baseline, at 5, 9, 12, 16, 46 and 53 weeks
change in the adipocyte extracellular matrix gene and protein expression profile in relation to weight regain during follow-up
In LCD-group and VLCD-group
Adipocyte extracellular matrix gene expression profile assessed:
- micro-arrays on RNA expression
- protein expression
- Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9
Measured: at baseline, at 5, 9, 12, 16, 46 and 53 weeks
change in adipocyte stress proteins expression due to dietary intervention (VLCD-group)
VLCD diet group
Adipocyte stress proteins expression:
- components of stress fibers and focal adhesions, like integrins
- 43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta
Measured: at baseline and after 5 weeks of VLCD diet
change in adipocyte stress proteins expression during weight-stable period (VLCD-group)
VLCD diet group
Adipocyte stress proteins expression:
- components of stress fibers and focal adhesions, like integrins
- 43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta
Measured: after 5 weeks of VLCD diet and at 9 weeks
change in adipocyte stress proteins expression during follow-up period (VLCD-group)
VLCD diet group
Adipocyte stress proteins expression:
- components of stress fibers and focal adhesions, like integrins
- 43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta
Measured: at 9 weeks and after follow-up period at week 46
change in adipocyte stress proteins expression due to dietary intervention (LCD-group)
LCD diet group
Adipocyte stress proteins expression:
- components of stress fibers and focal adhesions, like integrins
- 43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta
Measured: at baseline and after 12 weeks of LCD diet
change in adipocyte stress proteins expression during weight-stable period (LCD-group)
LCD diet group
Adipocyte stress proteins expression:
- components of stress fibers and focal adhesions, like integrins
- 43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta
Measured: after 12 weeks of LCD diet and at week 16
change in adipocyte stress proteins expression during follow-up period (LCD-group)
LCD diet group
Adipocyte stress proteins expression:
- components of stress fibers and focal adhesions, like integrins
- 43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta
Measured: at week 16 and after follow-up period at 53 weeks
change in adipocyte stress proteins expression in the LCD-group compared to the VLCD-group
Adipocyte stress proteins expression:
- components of stress fibers and focal adhesions, like integrins
- 43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta
Measured: at baseline, at 5, 9, 12, 16, 46 and 53 weeks
change in adipocyte stress proteins expression in relation to weight regain during follow-up
In LCD-group and VLCD-group
Adipocyte stress proteins expression:
- components of stress fibers and focal adhesions, like integrins
- 43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta
Measured: at baseline, at 5, 9, 12, 16, 46 and 53 weeks
change in physiological parameters due to dietary intervention (VLCD-group)
Physiological parameters:
Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat
Measured: at baseline and after 5 weeks of VLCD diet
change in physiological parameters during weight-stable period (VLCD-group)
Physiological parameters:
Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat
Measured: after 5 weeks of VLCD diet and at 9 weeks
change in physiological parameters during follow-up period (VLCD-group)
Physiological parameters:
Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat
Measured: at 9 weeks and after follow-up at 46 weeks
change in physiological parameters due to dietary intervention (LCD-group)
Physiological parameters:
Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat
Measured: at baseline and after 12 weeks of LCD diet
change in physiological parameters during weight-stable period (LCD-group)
Physiological parameters:
Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat
Measured: after 12 weeks of LCD diet and at 16 weeks
change in physiological parameters during follow-up (LCD-group)
Physiological parameters:
Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat
Measured: at 16 weeks and after follow-up at 53 weeks
Changes in physiological parameters in the LCD-group compared to the VLCD-group
Physiological parameters:
Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat
Measured: at baseline, at 5, 9, 12, 16, 46 and 53 weeks
Changes in physiological parameters in relation to weight regain during follow-up
Physiological parameters:
Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat
Measured: at baseline, at 5, 9, 12, 16, 46 and 53 weeks
change in plasma metabolic parameters due to dietary intervention (VLCD-group)
Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:
Glucose, insulin, free fatty acid, glycerol and triglycerides
Measured: at baseline and after 5 weeks of VLCD diet
change in plasma metabolic parameters during weight-stable period (VLCD-group)
Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:
Glucose, insulin, free fatty acid, glycerol and triglycerides
Measured: after 5 weeks of VLCD diet and at 9 weeks
change in plasma metabolic parameters during follow-up period (VLCD-group)
Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:
Glucose, insulin, free fatty acid, glycerol and triglycerides
Measured: at 9 weeks and after follow-up at 46 weeks
change in plasma metabolic parameters due to dietary intervention (LCD-group)
Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:
Glucose, insulin, free fatty acid, glycerol and triglycerides
Measured: at baseline and after 12 weeks of LCD diet
change in plasma metabolic parameters during weight-stable period (LCD-group)
Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:
Glucose, insulin, free fatty acid, glycerol and triglycerides
Measured: after 12 weeks of LCD diet and at 16 weeks
change in plasma metabolic parameters during follow-up (LCD-group)
Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:
Glucose, insulin, free fatty acid, glycerol and triglycerides
Measured: at 16 weeks and after follow-up at 53 weeks
Changes in plasma metabolic parameters in the LCD-group compared to the VLCD-group
Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:
Glucose, insulin, free fatty acid, glycerol and triglycerides
Measured: at baseline, at 5, 9, 12, 16, 46 and 53 weeks
Changes in plasma metabolic parameters in relation to weight regain during follow-up
In LCD-group and VLCD-group
Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:
Glucose, insulin, free fatty acid, glycerol and triglycerides
Measured: at baseline, at 5, 9, 12, 16, 46 and 53 weeks
change in fat cell size and fat cell number due to the dietary intervention (VLCD-group)
Measured: at baseline and after 5 weeks of VLCD diet
change in fat cell size and fat cell number during weight-stable period (VLCD-group)
Measured: after 5 weeks of VLCD diet and at 9 weeks
change in fat cell size and fat cell number during follow-up period (VLCD-group)
Measured: at 9 weeks and after follow-up at 46 weeks
change in fat cell size and fat cell number due to dietary intervention (LCD-group)
Measured: at baseline and after 12 weeks of LCD diet
change in fat cell size and fat cell number during weight-stable period (LCD-group)
Measured: after 12 weeks of LCD diet and at 16 weeks
change in fat cell size and fat cell number during follow-up (LCD-group)
Measured: at 16 weeks and after follow-up at 53 weeks
Changes in fat cell size and fat cell number in the LCD-group compared to the VLCD-group
Measured: at baseline, at 5, 9, 12, 16, 46 and 53 weeks
Changes in fat cell size and fat cell number in relation to weight regain after weight loss
In LCD-group and VLCD-group
Measured: at baseline, at 5, 9, 12, 16, 46 and 53 weeks
change in breath volatile organic compounds due to the dietary intervention (VLCD-group)
Measured: at baseline and after 5 weeks of VLCD diet
change in breath volatile organic compounds during weight-stable period (VLCD-group)
Measured: after 5 weeks of VLCD diet and at 9 weeks
change in breath volatile organic compounds during follow-up period (VLCD-group)
Measured: at 9 weeks and after follow-up at 46 weeks
change in breath volatile organic compounds due to dietary intervention (LCD-group)
Measured: at baseline and after 12 weeks of LCD diet
change in breath volatile organic compounds during weight-stable period (LCD-group)
Measured: after 12 weeks of LCD diet and at 16 weeks
change in breath volatile organic compounds during follow-up (LCD-group)
Measured: at 16 weeks and after follow-up at 53 weeks
Changes in breath volatile organic compounds in the LCD-group compared to the VLCD-group
Measured: at baseline, at 5, 9, 12, 16, 46 and 53 weeks
Changes in breath volatile organic compounds in relation to weight regain during follow-up
In LCD-group and VLCD-group
Measured: at baseline, at 5, 9, 12, 16, 46 and 53 weeks
change in inflammatory parameters due to the dietary intervention (VLCD-group)
In VLCD-group.
Inflammatory parameters are analyzed in:
- Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
- Micro-array
- PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)
Measured: at baseline and after 5 weeks of VLCD diet
change in inflammatory parameters during weight-stable period (VLCD-group)
In VLCD-group.
Inflammatory parameters are analyzed in:
- Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
- Micro-array
- PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)
Measured: after 5 weeks of VLCD diet and at 9 weeks
change in inflammatory parameters during follow-up period (VLCD-group)
In VLCD-group.
Inflammatory parameters are analyzed in:
- Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
- Micro-array
- PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)
Measured: at 9 weeks and after follow-up at 46 weeks
change in inflammatory parameters due to dietary intervention (LCD-group)
In LCD-group.
Inflammatory parameters are analyzed in:
- Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
- Micro-array
- PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)
Measured: at baseline and after 12 weeks of LCD diet
change in inflammatory parameters during weight-stable period (LCD-group)
In LCD-group.
Inflammatory parameters are analyzed in:
- Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
- Micro-array
- PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)
Measured: after 12 weeks of LCD diet and at 16 weeks
change in inflammatory parameters during follow-up (LCD-group)
In LCD-group.
Inflammatory parameters are analyzed in:
- Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
- Micro-array
- PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)
Measured: at 16 weeks and after follow-up at 53 weeks
Changes in inflammatory parameters in the LCD-group compared to the VLCD-group
Inflammatory parameters are analyzed in:
- Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
- Micro-array
- PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)
Measured: at baseline, at 5, 9, 12, 16, 46 and 53 weeks
Changes in inflammatory parameters in relation to weight regain during the follow-up
Inflammatory parameters are analyzed in:
- Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
- Micro-array
- PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)
Measured: at baseline, at 5, 9, 12, 16, 46 and 53 weeks
Changes in protein concentration of metabolic parameters due to the dietary intervention (VLCD-group)
Protein concentrations of metabolic parameters, including:
CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS
Measured: at baseline and after 5 weeks of VLCD diet
Changes in protein concentration of metabolic parameters during weight-stable period (VLCD-group)
Protein concentrations of metabolic parameters, including:
CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS
Measured: after 5 weeks of VLCD diet and at 9 weeks
change in protein concentration of metabolic parameters during follow-up (VLCD-group)
Protein concentrations of metabolic parameters, including:
CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS
Measured: at 9 weeks and after follow-up at 46 weeks
change in protein concentration of metabolic parameters due to dietary intervention (LCD-group)
Protein concentrations of metabolic parameters, including:
CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS
Measured: at baseline and after 12 weeks of LCD diet
change in protein concentration of metabolic parameters during weight-stable period (LCD-group)
Protein concentrations of metabolic parameters, including:
CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS
Measured: after 12 weeks of LCD diet and at 16 weeks
change in protein concentration of metabolic parameters during follow-up (LCD-group)
Protein concentrations of metabolic parameters, including:
CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS
Measured: at 16 weeks and after follow-up at 53 weeks
change in protein concentration of metabolic parameters in the LCD-group compared to the VLCD-group
Protein concentrations of metabolic parameters, including:
CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS
Measured: at baseline, at 5, 9, 12, 16, 46 and 53 weeks
change in protein concentration of metabolic parameters in relation to weight regain during follow-up
In LCD-group and VLCD-group
Protein concentrations of metabolic parameters, including:
CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS
Measured: at baseline, at 5, 9, 12, 16, 46 and 53 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- Marleen van Baak, Professor, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559415
- Sponsor's protocol ID
- 38099
- Acronym
- ADIPOSTRESS
- Status last verified
- Dec 2014
- First submitted
- 12 Mar 2012
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Qiao Q, Bouwman FG, van Baak MA, Roumans NJT, Vink RG, Mariman ECM. Plasma Levels of Triglycerides and IL-6 Are Associated With Weight Regain and Fat Mass Expansion. J Clin Endocrinol Metab. 2022 Jun 16;107(7):1920-1929. doi: 10.1210/clinem/dgac198.
PubMed 35366329Tareen SHK, Kutmon M, de Kok TM, Mariman ECM, van Baak MA, Evelo CT, Adriaens ME, Arts ICW. Stratifying cellular metabolism during weight loss: an interplay of metabolism, metabolic flexibility and inflammation. Sci Rep. 2020 Feb 3;10(1):1651. doi: 10.1038/s41598-020-58358-z.
PubMed 32015415Roumans NJT, Wang P, Vink RG, van Baak MA, Mariman ECM. Combined Analysis of Stress- and ECM-Related Genes in Their Effect on Weight Regain. Obesity (Silver Spring). 2018 Mar;26(3):492-498. doi: 10.1002/oby.22093. Epub 2018 Feb 5.
PubMed 29399976Vink RG, Roumans NJ, van der Kolk BW, Fazelzadeh P, Boekschoten MV, Mariman EC, van Baak MA. Adipose Tissue Meal-Derived Fatty Acid Uptake Before and After Diet-Induced Weight Loss in Adults with Overweight and Obesity. Obesity (Silver Spring). 2017 Aug;25(8):1391-1399. doi: 10.1002/oby.21903. Epub 2017 Jun 22.
PubMed 28639346Roumans NJ, Vink RG, Fazelzadeh P, van Baak MA, Mariman EC. A role for leukocyte integrins and extracellular matrix remodeling of adipose tissue in the risk of weight regain after weight loss. Am J Clin Nutr. 2017 May;105(5):1054-1062. doi: 10.3945/ajcn.116.148874. Epub 2017 Mar 15.
PubMed 28298393Vink RG, Roumans NJ, Cajlakovic M, Cleutjens JPM, Boekschoten MV, Fazelzadeh P, Vogel MAA, Blaak EE, Mariman EC, van Baak MA, Goossens GH. Diet-induced weight loss decreases adipose tissue oxygen tension with parallel changes in adipose tissue phenotype and insulin sensitivity in overweight humans. Int J Obes (Lond). 2017 May;41(5):722-728. doi: 10.1038/ijo.2017.38. Epub 2017 Feb 9.
PubMed 28179648
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adipocyte-Driven Mechanism For Weight Regain After Weight Loss: The Yo-Yo Effect
- ClinicalTrials.gov ID
- NCT01559415
- Acronym / sponsor ID
- ADIPOSTRESS / 38099
- Conditions
- Obesity, Weight Loss, Diet
- Keywords
- Adipocytes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Mar 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 21 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Almost half of the Dutch population is currently characterized by overweight and obesity. Losing weight is not the problem in obesity treatment, it is the seemingly obligatory weight regain after weight loss: the yoyo-effect. The primary objective of this study is to investigate the association between the weight-loss-induced cellular stress response and the rate of weight regain. The secondary objective is to investigate the differences in cellular stress response and weight regain after rapid and slow weight loss. To investigate this, subjects will receive meal replacements replacing either all or part of the daily meals during the intervention period. THe first group will consume 500 kcal/d diet for 5 weeks while the second group consumes a 1250 kcal/d diet for 3 months, both followed by 1 week normalization and a 2 week strict weight maintenance diet. During the 9-month follow-up period subjects will receive dietary advice according to the Dutch recommendations for healthy eating. The association between the amount of weight regain after the weight loss period and changes in adipokines, parameters of adipocyte metabolism, in vivo adipose tissue metabolism, adipocyte extracellular matrix gene expression profiles, adipocyte stress protein expression and gene polymorphisms in selected genes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Very Low Calorie Diet | Experimental | Other: Meal replacement diet using Modifast |
| Low Calorie Diet | Active comparator | Other: Normal diet combined with Modifast diet1250 kcal diet in which Modifast is given in combination with a normal diet |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age (years): 20-65
- Body Mass Index (kg/m2): 28-35
- Non-smokers
Key exclusion criteria (14 listed)
- Subjects using prescription medication, or suffering from diseases or conditions that might influence the outcome of the study: this concerns diseases/medication that influence body weight regulation (malabsorption, untreated hypo/hyperthyroidism, eating disorders, systemic use of steroids, etc.) and obesity-related cardiovascular risk factors (heart disease, systolic and diastolic blood pressures > 160/100 mmHg, blood glucose > 6.1 mmol L-1, blood cholesterol > 7 mmol L-1, blood triglycerides > 3 mmol L-1)
- marked alcohol consumption > 21 alcoholic units week-1 (male), or >14 alcoholic units week-1 (female)
- planned major changes in physical activity during the study to an extent that might interfere with the study outcome as judged by the investigator;
- blood donation within the past 2 months prior to the study
- weight change of >3 kg within 2 months prior to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meal replacement diet using Modifastmodifast intensive diet replacing all regular meals (500 kcal/d) for 5 weeks | Other | Very Low Calorie Diet |
| Normal diet combined with Modifast dietCombination of modifast and regular diet (1250 kcal/d) for 3 months | Other | Low Calorie Diet |
Primary outcome
change in weight following weight loss
Time frame: at 9 weeks and at 46 weeks
VLCD diet group
change in weight following weight loss
Time frame: at 16 weeks and at 53 weeks
LCD diet group
88 secondary outcomes
change in adipokine profile due to dietary intervention (VLCD-group)
Time frame: at baseline and after 5 weeks of VLCD diet
change in adipokine during weight stable-period (VLCD-group)
Time frame: after 5 weeks of VLCD diet and after 9 weeks
change in adipokine profile during follow-up (VLCD-group)
Time frame: at 9 weeks and after follow-up at 46 weeks
change in adipokine profile due to dietary intervention (LCD-group)
Time frame: at baseline and after 12 weeks of LCD diet
change in adipokine profile during weight-stable period (LCD-group)
Time frame: after 12 weeks of LCD diet and at 16 weeks
change in adipokine profile during follow-up (LCD-group)
Time frame: at 16 weeks and after follow-up at 53 weeks
Changes in adipokine profile in the LCD-group compared to the VLCD-group
Time frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks
change in adipokine profile in relation to weight regain during follow-up
Time frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks
change in parameters of adipocyte fat metabolism due to dietary intervention (VLCD-group)
Time frame: at baseline and after 5 weeks of VLCD diet
change in parameters of adipocyte fat metabolism during weight-stable period (VLCD-group)
Time frame: after 5 weeks of VLCD diet and at 9 weeks
change in parameters of adipocyte fat metabolism during follow-up period (VLCD-group)
Time frame: at 9 weeks and after follow-up at 46 weeks
change in parameters of adipocyte fat metabolism due to dietary intervention (LCD-group)
Time frame: at baseline and after 12 weeks of LCD diet
change in parameters of adipocyte fat metabolism during weight-stable period (LCD-group)
Time frame: after 12 weeks of LCD diet and at 16 weeks
change in parameters of adipocyte fat metabolism during follow-up (LCD-group)
Time frame: at 16 weeks and after follow-up at 53 weeks
Changes in parameters of adipocyte fat metabolism in the LCD-group compared to the VLCD-group
Time frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks
change in parameters of adipocyte fat metabolism in relation to weight regain during follow-up
Time frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks
change in in-vivo adipose tissue metabolism due to dietary intervention (VLCD-group)
Time frame: at baseline and after 5 weeks of VLCD diet
change in in-vivo adipose tissue metabolism during weight-stable period (VLCD-group)
Time frame: after 5 weeks of VLCD diet and at 9 weeks
change in in-vivo adipose tissue metabolism during follow-up period (VLCD-group)
Time frame: at 9 weeks and after follow-up period at 46 weeks
change in in-vivo adipose tissue metabolism due to dietary intervention (LCD-group)
Time frame: at baseline and after 12 weeks of LCD diet
change in in-vivo adipose tissue metabolism during weight-stable period (LCD-group)
Time frame: after 12 weeks of LCD diet and at 16 weeks
change in in-vivo adipose tissue metabolism during follow-up period (LCD-group)
Time frame: at 16 weeks and after follow-up period at 53 weeks
change in in-vivo adipose tissue metabolism in the LCD-group compared to the VLCD-group
Time frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks
change in in-vivo adipose tissue metabolism in relation to weight regain during follow-up
Time frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks
change in the adipocyte extracellular matrix gene and protein expression profile due to dietary intervention (VLCD-group)
Time frame: at baseline and after 5 weeks of VLCD diet
change in the adipocyte extracellular matrix gene and protein expression profile during weight-stable period (VLCD-group)
Time frame: after 5 weeks of VLCD diet and at 9 weeks
change in the adipocyte extracellular matrix gene and protein expression profile during follow-up period (VLCD-group)
Time frame: at 9 weeks and after follow-up period at 46 weeks
change in the adipocyte extracellular matrix gene and protein expression profile due to dietary intervention (LCD-group)
Time frame: at baseline and after 12 weeks of LCD diet
change in the adipocyte extracellular matrix gene and protein expression profile during weight-stable period (LCD-group)
Time frame: after 12 weeks of LCD diet and at 16 weeks
change in the adipocyte extracellular matrix gene and protein expression profile during follow-up period (LCD-group)
Time frame: at 16 weeks and after follow-up period
change in the adipocyte extracellular matrix gene and protein expression profile in the LCD-group compared to the VLCD-group
Time frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks
change in the adipocyte extracellular matrix gene and protein expression profile in relation to weight regain during follow-up
Time frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks
change in adipocyte stress proteins expression due to dietary intervention (VLCD-group)
Time frame: at baseline and after 5 weeks of VLCD diet
change in adipocyte stress proteins expression during weight-stable period (VLCD-group)
Time frame: after 5 weeks of VLCD diet and at 9 weeks
change in adipocyte stress proteins expression during follow-up period (VLCD-group)
Time frame: at 9 weeks and after follow-up period at week 46
change in adipocyte stress proteins expression due to dietary intervention (LCD-group)
Time frame: at baseline and after 12 weeks of LCD diet
change in adipocyte stress proteins expression during weight-stable period (LCD-group)
Time frame: after 12 weeks of LCD diet and at week 16
change in adipocyte stress proteins expression during follow-up period (LCD-group)
Time frame: at week 16 and after follow-up period at 53 weeks
change in adipocyte stress proteins expression in the LCD-group compared to the VLCD-group
Time frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks
change in adipocyte stress proteins expression in relation to weight regain during follow-up
Time frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
- Derived from this study: PubMed 35366329Qiao Q, Bouwman FG, van Baak MA, Roumans NJT, Vink RG, Mariman ECM. Plasma Levels of Triglycerides and IL-6 Are Associated With Weight Regain and Fat Mass Expansion. J Clin Endocrinol Metab. 2022 Jun 16;107(7):1920-1929. doi: 10.1210/clinem/dgac198.
- Derived from this study: PubMed 32015415Tareen SHK, Kutmon M, de Kok TM, Mariman ECM, van Baak MA, Evelo CT, Adriaens ME, Arts ICW. Stratifying cellular metabolism during weight loss: an interplay of metabolism, metabolic flexibility and inflammation. Sci Rep. 2020 Feb 3;10(1):1651. doi: 10.1038/s41598-020-58358-z.
- Derived from this study: PubMed 29399976Roumans NJT, Wang P, Vink RG, van Baak MA, Mariman ECM. Combined Analysis of Stress- and ECM-Related Genes in Their Effect on Weight Regain. Obesity (Silver Spring). 2018 Mar;26(3):492-498. doi: 10.1002/oby.22093. Epub 2018 Feb 5.
- Derived from this study: PubMed 28639346Vink RG, Roumans NJ, van der Kolk BW, Fazelzadeh P, Boekschoten MV, Mariman EC, van Baak MA. Adipose Tissue Meal-Derived Fatty Acid Uptake Before and After Diet-Induced Weight Loss in Adults with Overweight and Obesity. Obesity (Silver Spring). 2017 Aug;25(8):1391-1399. doi: 10.1002/oby.21903. Epub 2017 Jun 22.
- Derived from this study: PubMed 28298393Roumans NJ, Vink RG, Fazelzadeh P, van Baak MA, Mariman EC. A role for leukocyte integrins and extracellular matrix remodeling of adipose tissue in the risk of weight regain after weight loss. Am J Clin Nutr. 2017 May;105(5):1054-1062. doi: 10.3945/ajcn.116.148874. Epub 2017 Mar 15.
- Derived from this study: PubMed 28179648Vink RG, Roumans NJ, Cajlakovic M, Cleutjens JPM, Boekschoten MV, Fazelzadeh P, Vogel MAA, Blaak EE, Mariman EC, van Baak MA, Goossens GH. Diet-induced weight loss decreases adipose tissue oxygen tension with parallel changes in adipose tissue phenotype and insulin sensitivity in overweight humans. Int J Obes (Lond). 2017 May;41(5):722-728. doi: 10.1038/ijo.2017.38. Epub 2017 Feb 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marleen van Baak, Professor principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal replacement diet using Modifast and Normal diet combined with Modifast diet in people with Obesity and Weight Loss, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in weight following weight loss (time frame: at 9 weeks and at 46 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01559415, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2014.