ObesityPERSONNCT03708419
Personalized Glucose Optimization Through Nutritional Intervention
A study testing Optimal diet and Suboptimal diet in people with Obesity and Pre-diabetic, run by Maastricht University Medical Center at 2 sites in Netherlands.
Trial summary
Maintaining well-controlled blood glucose concentrations is essential in the prevention of chronic cardiometabolic diseases. The blood glucose response to dietary and/or lifestyle patterns may vary between individuals. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Pre-diabetic, Type 2 Diabetes Mellitus
- What is being tested?
- Optimal diet and Suboptimal diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 2 sitesNetherlands
- Study dates
- 4 Jun 2018to 29 Nov 2021
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 25 to <40 kg/m2
- Predominantly muscle (MIR) or liver (LIR) insulin resistant
- Weight stability for at least 3 months (+/- 3 kg)
Who cannot join
- Diseases
- Pre-diagnosis of type 1 or type 2 diabetes mellitus
- Renal or hepatic malfunctioning (pre-diagnosis or determined based on alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT) and creatinine values)
- Gastrointestinal diseases or abdominal surgery (allowed i.e.: appendectomy, cholecystectomy)
- Food allergies, intolerances (including gluten/lactose intolerance) and/or dietary restrictions interfering with the study (including special diets, vegetarians and eating disorders)
- Cardiovascular diseases (e.g. heart failure) or cancer (e.g. non-invasive skin cancer allowed)
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- High blood pressure (untreated >160/100 mmHg, drug-regulated >140/90 mmHg)
- Diseases affecting glucose and/or lipid metabolism (e.g. pheochromocytoma, Cushing's syndrome, acromegaly)
- Anemia defined as hemoglobin (Hb) men <8.5 and women <7.5 mmol/l
- Diseases with a life expectation shorter than 5 years
- Major mental disorders
- Drug treated thyroid diseases (well substituted hypothyroidism is allowed inclusion)
- Other physical/mental conditions that could interfere with study outcomes
- Medication
- Medication known to interfere with study outcomes (e.g. peroxisome proliferator-activated receptor-α (PPAR-α) or PPAR-γ agonists (fibrates), sulfonylureas, biguanides, α-glucosidase inhibitors, thiazolidinediones, repaglinide, nateglinide and insulin, chronic use of NSAIDs)
- Use of anticoagulants
- Use of antidepressants (stable use ≥ 3 months prior to and during the study is allowed)
- Use of statins (stable use ≥ months prior to and during study allowed)
- Use of β-blockers (only for the extensive phenotyping participants)
- Chronic corticosteroids treatment (>7 consecutive days of treatment)
- Use of antibiotics within 3 months prior to the study
- Lifestyle
- Participation in regular sports activities (>4 hours per week)
- Having a restricted dietary pattern interfering with the study diets (e.g. vegan or Atkins diet)
- Plans to lose weight
- Abuse of alcohol (alcohol consumption >14 units/week) and/or drugs (cannabis included)
- Not willing to limit alcohol consumption to 7 drinks per week
- Regular smoking (including use of e-cigarettes)
- Use of strong vitamins or dietary supplements (e.g. pre- or probiotics) expected to interfere with the study outcomes
- Other
- Pregnant or lactating women who are planning to become pregnant
- Inability to comply with the study diet
- Blood donation within the last 3 months
- Participation in possibly interfering studies within the last 3 months
- Inability to understand study information and/or communicate with staff
- Unwillingness to be randomized or sign informed consent
- Unwillingness to save data for 15 years
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Department of Human Biology, Maastricht University Medical Centre
Maastricht, 6200MD
Wageningen University and Research
Wageningen, 6700AA
About this study
Maintaining well-controlled blood glucose concentrations is essential in the prevention of chronic cardiometabolic diseases. The blood glucose response to dietary and/or lifestyle patterns may vary between individuals. Insulin resistance in specific metabolic organs such as skeletal muscle, adipose tissue or the liver may underlie differential blood glucose responses.
This dietary intervention study aims to obtain insight into the metabolic and lifestyle determinants of postprandial blood glucose responses, and to establish the effect of macronutrient manipulation of a 12-week dietary intervention on blood glucose homeostasis in metabolically different subgroups an its relationship to physical and mental performance and well-being.
Read the detailed description
Study design: this study is a double-blinded, randomised, controlled, parallel design dietary intervention study. The study will be conducted at Maastricht University and Wageningen University and Research, the Netherlands.
Study population: the study population will consist of 240 men and women between 40-75 years old, with a BMI 25-40 kg/m2. Participants will be either muscle insulin resistant (MIR) or liver insulin resistant (LIR), as classified by an oral glucose tolerance test (OGTT) during the screening procedure. A subgroup of 80 participants will be selected for detailed metabolic phenotyping.
Intervention: for 12 weeks, participants will receive either a diet optimal for MIR (high in mono-unsaturated fatty acids) or a diet optimal for LIR (high in protein and fiber, low in fat) with respect to changes in disposition index. Participants will be randomly allocated to one of the two diets. Detailed laboratory and daily life phenotyping will be done pre- and post intervention.
- Conditions
- Obesity, Pre-diabetic, Type 2 Diabetes Mellitus
- Being tested
- Optimal diet, Suboptimal diet
- Keywords
- Insulin resistance, Personalized nutrition
- Medical subject headings
- Obesity, Glucose Intolerance, Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimal dietOther
Based on a 7-points OGTT, participants will be classified as MIR or LIR. The hypothesized optimal diet for MIR has a moderate fat content which is high in mono- unsaturated fatty acids (HMUFA) with a macronutrient breakdown of 38 E% from fat (20% MUFA, 10% polyunsaturated fatty acids (PUFA), 8% saturated fatty acids (SFA)), 48 E% from carbohydrates (CHO, 35% complex), and 14 E% from protein (35-40% plant protein). The hypothesized optimal diet for LIR is low in fat, high in protein (LFHP) and increased fiber with a macronutrient breakdown of <28 E% from fat (10% MUFA, 10% PUFA, 8% SFA), 48 E% from CHO (35% complex), and 24 E% from protein (35-40% plant protein), and an additional supplement of 6g of soluble fiber per day. Participants wil be randomly allocated to one of the two diets.
Suboptimal dietOther
The optimal diet for the other metabolic phenotype will be considered as "suboptimal"/ control diet. For the MIR phenotype this is the high protein, high fiber, low fat diet; for the LIR phenotype this is the high monounsaturated fatty acid diet. See the description above.
| Study group | Role | What they receive |
|---|---|---|
| Optimal diet | Experimental | Participants will follow a diet for a total duration of 12 weeks, optimal for their metabolic phenotype. For participants with muscle insulin resistance (MIR) this will be a diet high in monounsaturated fatty acids, for participants with liver insulin resistance (LIR) this will be a diet high in protein and fiber and low in fat. Receives: Other: Optimal diet |
| Suboptimal diet | Experimental | Participants will follow a diet for a total duration of 12 weeks, suboptimal for their metabolic phenotype. For participants with liver insulin resistance (LIR) this will be a diet high in monounsaturated fatty acids, for participants with muscle insulin resistance (MIR) this will be a diet high in protein and fiber and low in fat. Receives: Other: Suboptimal diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disposition index
The primary objective of this study is to establish the effect of a metabolically targeted, optimal versus suboptimal macronutrient manipulated 12-week dietary intervention on the change in disposition index, a composite marker of first phase insulin secretion and insulin sensitivity during a 2-hour 7-points oral glucose tolerance test (OGTT). Disposition index will be calculated as follows: [Insulin sensitivity index (ISI) * (AUC30 min insulin / AUC30 min glucose)], where AUC30 min is the area under the curve between 0 and 30 minutes of the OGTT for insulin (pmol/l) and glucose (mmol/l), respectively, and ISI is defined as: [10,000 ÷ square root of (fasting plasma glucose (mmol/l) x fasting insulin (pmol/l)) x (mean glucose (mmol/l) x mean insulin (pmol/l))]. Higher values represent a higher insulin sensitivity.
Measured: Change from baseline at week 12 dietary intervention
Secondary outcomes (40)
Mean 24h glucose concentrations
Optimal versus suboptimal diet. The mean 24h glucose concentrations will be measured continuously with the iPro2 device and Enlite Glucose Sensor (Medtronic) and expressed as mmol/L.
Measured: Change from baseline at week 12 dietary intervention
Glucose incremental area under the curve (iAUC)
Optimal versus suboptimal diet. The iAUC will be calculated using the trapezoid rule from data obtained from the iPro2 device and Enlite Glucose Sensor (Medtronic). The iAUC provides a summary measure of the net increase in glucose levels above the fasting level during a 24-hour period and is expressed as mmol/min/L.
Measured: Change from baseline at week 12 dietary intervention
The frequency and duration of hypo- and hyperglycemia
Optimal versus suboptimal diet. The frequency and duration of hypo- and hyperinsulinemia will be monitored using the iPro2 device and Enlite Glucose Sensor (Medtronic) and is defined as a glucose level of ≥10.0 mmol/l for hyperglycemia, whilst hypoglycemia will be defined as a glucose concentration ≤3.9 mmol/l.
Measured: Change from baseline at week 12 dietary intervention
Glucose tolerance
Optimal versus suboptimal diet. Determined by 2-hour glucose values (mmol/L) during an oral glucose tolerance test.
Measured: Change from baseline at week 12 dietary intervention
Muscle insulin sensitivity
Optimal versus suboptimal diet. Determined during a 2-hour, 7-points oral glucose tolerance test. The muscle insulin sensitivity index (MISI) will be calculated as follows: MISI (mmol/l/min/pmol/l) = (dG/dt) / mean plasma insulin concentration (pmol/l) during OGTT. Here, dG/dt is the rate of decay of plasma glucose concentration (mmol/L) during the OGTT, calculated as the slope of the least square fit to the decline in plasma glucose concentration from peak to nadir. Higher values represent higher muscle insulin sensitivity.
Measured: Change from baseline at week 12 dietary intervention
Hepatic insulin sensitivity
Optimal versus suboptimal diet. Determined during a 2-hour, 7-points oral glucose tolerance test. The hepatic insulin resistance index (HIRI) will be calculated using the square root of the product of the area under curves (AUCs) for glucose and insulin during the first 30 min of the OGTT - i.e., square root (glucose0-30 [AUC in mmol/l·h] · insulin 0-30 [AUC in pmol/l·h). Higher IR values represent lower hepatic insulin sensitivity.
Measured: Change from baseline at week 12 dietary intervention
Insulin sensitivity
Optimal versus suboptimal diet. Glucose infusion rate (mg/kg/min) during a 2-step hyper-insulinemic euglycemic clamp as golden standard method.
Measured: Change from baseline at week 12 dietary intervention
Body composition
Optimal versus suboptimal diet. Body composition will be determined by using a dual-energy X-ray absorptiometry scan (DXA).
Measured: Change from baseline at week 12 dietary intervention
Waist circumference
Optimal versus suboptimal diet. Waist circumferences in centimeters.
Measured: Change from baseline at week 12 dietary intervention
Hip circumferences
Optimal versus suboptimal diet. Hip circumferences in centimeters.
Measured: Change from baseline at week 12 dietary intervention
Body fat distribution
Optimal versus suboptimal diet. Magnetic Resonance Imaging (MRI)(UM) and Magnetic resonance spectroscopy (1H-MRS)(WUR) measurements will be included to quantify both subcutaneous and visceral fat depots, and ectopic fat deposition (e.g. in liver and muscle).
Measured: Change from baseline at week 12 dietary intervention
Blood pressure
Optimal versus suboptimal diet. Systolic and diastolic blood pressure in mmHg.
Measured: Change from baseline at week 12 dietary intervention
Fasting circulating metabolic markers
Optimal versus suboptimal diet. Fasting circulating metabolic markers include: glucose, insulin, hemoglobin A1c (HbA1c), triacylglycerol, free glycerol, free fatty acids (FFA), lactate, high density lipoprotein (HDL), total cholesterol, short chain fatty acids (SCFA), bile acids, glucagon-like peptide-1 (GLP-1), peptide YY (PYY).
Measured: Change from baseline at week 12 dietary intervention
Fasting blood lipid spectrum
Optimal versus suboptimal diet. Metabolomics will be used to determine the fasting blood lipid spectrum.
Measured: Change from baseline at week 12 dietary intervention
Postprandial circulating metabolic markers
Optimal versus suboptimal diet. Postprandial circulating metabolic markers will be determined during a high-fat mixed-meal test and include: glucose, insulin, triacylglycerol, free glycerol, free fatty acids (FFA), lactate, high density lipoprotein (HDL), total cholesterol, short chain fatty acids (SCFA), bile acids, glucagon-like peptide-1 (GLP-1), peptide YY (PYY).
Measured: Change from baseline at week 12 dietary intervention
Energy expenditure
Optimal versus suboptimal diet. Fasting and insulin-stimulated energy expenditure will be determined by indirect calorimetry during a 2-step hyperinsulinemic-euglycemic clamp.
Measured: Change from baseline at week 12 dietary intervention
Substrate oxidation
Optimal versus suboptimal diet. Fasting and insulin-stimulated substrate oxidation will be determined by indirect calorimetry during a 2-step hyperinsulinemic-euglycemic clamp.
Measured: Change from baseline at week 12 dietary intervention
Fecal microbiota composition
Optimal versus suboptimal diet. Fecal samples to be used for analysing microbiota composition will be collected.
Measured: Change from baseline at week 12 dietary intervention
Oral microbiota composition
Optimal versus suboptimal diet. Saliva samples to be used for analysing microbiota composition will be collected.
Measured: Change from baseline at week 12 dietary intervention
Self-reported perceived stress
Optimal versus suboptimal diet. Perceived stress will be assessed using a 10-item perceived stress scale (PSS-10). Items will be scored based on a 5-point Likert scale, with higher scores representing higher perceived stress levels.
Measured: Change from baseline at week 12 dietary intervention
Self-reported self efficacy in physical activity
Optimal versus suboptimal diet. Self efficacy in physical activity will be assessed using Likert scales, determining an individual's ability to achieve performing physical activity.
Measured: Change from baseline at week 12 dietary intervention
Self-reported sleep behaviour
Optimal versus suboptimal diet. Sleep behaviour will be assessed using the Munich Chronotype Questionnaire (MCTQ).
Measured: Change from baseline at week 12 dietary intervention
Self-reported sleep quality over a 1 month period
Optimal versus suboptimal diet. Sleeping quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI).
Measured: Change from baseline at week 12 dietary intervention
Self-reported daytime sleepiness
Optimal versus suboptimal diet. Daytime sleepiness is assessed using the 8-item Epworth Sleepiness Scale (ESS). Items will be scored on a scale of 0-3, with a higher score representing a higher probability of falling asleep.
Measured: Change from baseline at week 12 dietary intervention
Self-reported fatigue
Optimal versus suboptimal diet. Self-reported fatigue will be assessed using the Chalder Fatigue Scale.
Measured: Change from baseline at week 12 dietary intervention
Self-reported sedentary behaviour
Optimal versus suboptimal diet. Sedentary behaviour will be assessed using the sedentary behaviour questionnaire (AQUAA).
Measured: Change from baseline at week 12 dietary intervention
Self-reported physical activity
Optimal versus suboptimal diet. Self-reported physical activity will be assessed using the physical activity questionnaire (Baecke).
Measured: Change from baseline at week 12 dietary intervention
Self-reported eating rate
Optimal versus suboptimal diet. Self-reported eating rate will be assessed using the eating rate index.
Measured: Change from baseline at week 12 dietary intervention
Self-reported intestinal health
Optimal versus suboptimal diet. Self-reported intestinal health will be assessed using an intestinal health questionnaire and the Bristol Stool Chart.
Measured: Change from baseline at week 12 dietary intervention
Self-reported quality of life
Optimal versus suboptimal diet. Self-reported quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). Higher scores represent less disability.
Measured: Change from baseline at week 12 dietary intervention
Physical activity patterns
Optimal versus suboptimal diet. Physical activity patterns will be monitored continuously with the ActivPAL3 device.
Measured: Change from baseline at week 12 dietary intervention
Cognitive performance
Optimal versus suboptimal diet. Cognitive function will be assessed using the Cambridge Neuropsychological Test Automated Battery.
Measured: Change from baseline at week 12 dietary intervention
Subcutaneous adipose tissue biopsy
Optimal versus suboptimal diet. Subcutaneous adipose tissue biopsies will be taken for histology and gene and protein expression analysis.
Measured: Change from baseline at week 12 dietary intervention
Skeletal muscle biopsy
Optimal versus suboptimal diet. Skeletal muscle biopsies will be taken for histology and gene and protein expression analysis.
Measured: Change from baseline at week 12 dietary intervention
Advanced glycation end-product (AGE) accumulation
Optimal versus suboptimal diet. AGE accumulation will be measured by skin autofluorescence using an AGE reader (Diagnoptics)
Measured: Change from baseline at week 12 dietary intervention
Fasting immune metabolism (PBMCs)
Optimal versus suboptimal diet. Assessment of PBMCs as measure of fasting immune metabolism
Measured: Change from baseline at week 12 dietary intervention
Carotid artery reactivity
Optimal versus suboptimal diet. Assessment of (peripheral) vascular function by carotid artery reactivity (CAR) in response to a cold pressor test.
Measured: Change from baseline at week 12 dietary intervention
Food preferences
Optimal versus suboptimal diet. Food preferences will be assessed by using the computer-based Macronutrient and Taste Preference Ranking Task (MTPRT).
Measured: Change from baseline at week 12 dietary intervention
Intervention effects on all above outcomes within the LIR and MIR group.
In contrast to the other outcomes, the intervention effect within the MIR and LIR group will be analysed for all above mentioned outcomes (as compared to an analysis of optimal versus the suboptimal diet). MIR and LIR are two measures of insulin resistance, in primarily the muscle and liver, respectively. MIR and LIR can be modelled from an OGTT, as described above. Thus, for each of the outcomes described above, their change following 12 weeks of dietary intervention will be compared between the two metabolic phenotypes, MIR and LIR.
Measured: Change from baseline at week 12 dietary intervention
DNA analysis
Buffy coats will be collected for DNA analysis, pre-intervention only.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start4 Jun 2018
- Primary completion29 Nov 2021
- Study completion29 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Wageningen University and Research, Top Institute Food and Nutrition, Netherlands Organisation for Scientific Research
- Responsible party
- Sponsor
- Investigators
- Ellen E Blaak, Prof., Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708419
- Sponsor's protocol ID
- NL63768.068.17
- Acronym
- PERSON
- Status last verified
- Feb 2022
- First submitted
- 25 Apr 2018
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hoge A, Donneau AF, Dardenne N, Guillaume M, Afman LA, Feskens EJM, Goossens GH, Blaak EE. Differential associations of diet with hepatic and muscle insulin resistance: insights from an dietary pattern analysis in the PERSON study. Eur J Nutr. 2026 May 26;65(4):142. doi: 10.1007/s00394-026-03996-8.
PubMed 42191942Jardon KM, Umanets A, Venema K, Trouwborst I, Gijbels A, Hul GB, Siebelink E, Afman LA, Goossens GH, Blaak EE. Gut microbiota responses to isocaloric macronutrient modulation in tissue-specific insulin resistance: a secondary analysis of the PERSonalized glucose Optimization through Nutritional intervention (PERSON) randomized trial. Am J Clin Nutr. 2026 Jul;124(1):101340. doi: 10.1016/j.ajcnut.2026.101340. Epub 2026 May 5.
PubMed 42097279Jardon KM, Umanets A, Gijbels A, Trouwborst I, Hul GB, Siebelink E, Vliex LMM, Bastings JJAJ, Argamasilla R, Chenal E, Venema K, Afman LA, Goossens GH, Blaak EE. Distinct gut microbiota and metabolome features of tissue-specific insulin resistance in overweight and obesity. Gut Microbes. 2025 Dec;17(1):2501185. doi: 10.1080/19490976.2025.2501185. Epub 2025 May 7.
PubMed 40336254Gijbels A, Jardon KM, Trouwborst I, Manusama KC, Goossens GH, Blaak EE, Feskens EJ, Afman LA. Fasting and postprandial plasma metabolite responses to a 12-wk dietary intervention in tissue-specific insulin resistance: a secondary analysis of the PERSonalized glucose Optimization through Nutritional intervention (PERSON) randomized trial. Am J Clin Nutr. 2024 Aug;120(2):347-359. doi: 10.1016/j.ajcnut.2024.05.027. Epub 2024 Jun 6.
PubMed 38851634Trouwborst I, Jardon KM, Gijbels A, Hul G, Feskens EJM, Afman LA, Linge J, Goossens GH, Blaak EE. Body composition and body fat distribution in tissue-specific insulin resistance and in response to a 12-week isocaloric dietary macronutrient intervention. Nutr Metab (Lond). 2024 Apr 9;21(1):20. doi: 10.1186/s12986-024-00795-y.
PubMed 38594756Trouwborst I, Gijbels A, Jardon KM, Siebelink E, Hul GB, Wanders L, Erdos B, Peter S, Singh-Povel CM, de Vogel-van den Bosch J, Adriaens ME, Arts ICW, Thijssen DHJ, Feskens EJM, Goossens GH, Afman LA, Blaak EE. Cardiometabolic health improvements upon dietary intervention are driven by tissue-specific insulin resistance phenotype: A precision nutrition trial. Cell Metab. 2023 Jan 3;35(1):71-83.e5. doi: 10.1016/j.cmet.2022.12.002.
PubMed 36599304Gijbels A, Trouwborst I, Jardon KM, Hul GB, Siebelink E, Bowser SM, Yildiz D, Wanders L, Erdos B, Thijssen DHJ, Feskens EJM, Goossens GH, Afman LA, Blaak EE. The PERSonalized Glucose Optimization Through Nutritional Intervention (PERSON) Study: Rationale, Design and Preliminary Screening Results. Front Nutr. 2021 Jun 30;8:694568. doi: 10.3389/fnut.2021.694568. eCollection 2021.
PubMed 34277687
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Glucose Optimization Through Nutritional Intervention
- ClinicalTrials.gov ID
- NCT03708419
- Acronym / sponsor ID
- PERSON / NL63768.068.17
- Conditions
- Obesity, Pre-diabetic, Type 2 Diabetes Mellitus
- Keywords
- Insulin resistance, Personalized nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Wageningen University and Research, Top Institute Food and Nutrition, Netherlands Organisation for Scientific Research
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 29 Nov 2021 (actual)
- Study completion
- 29 Nov 2021 (actual)
- First posted
- 17 Oct 2018 (actual)
- 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.
Maintaining well-controlled blood glucose concentrations is essential in the prevention of chronic cardiometabolic diseases. The blood glucose response to dietary and/or lifestyle patterns may vary between individuals. Insulin resistance in specific metabolic organs such as skeletal muscle, adipose tissue or the liver may underlie differential blood glucose responses.
This dietary intervention study aims to obtain insight into the metabolic and lifestyle determinants of postprandial blood glucose responses, and to establish the effect of macronutrient manipulation of a 12-week dietary intervention on blood glucose homeostasis in metabolically different subgroups an its relationship to physical and mental performance and well-being.
Detailed description
Study design: this study is a double-blinded, randomised, controlled, parallel design dietary intervention study. The study will be conducted at Maastricht University and Wageningen University and Research, the Netherlands.
Study population: the study population will consist of 240 men and women between 40-75 years old, with a BMI 25-40 kg/m2. Participants will be either muscle insulin resistant (MIR) or liver insulin resistant (LIR), as classified by an oral glucose tolerance test (OGTT) during the screening procedure. A subgroup of 80 participants will be selected for detailed metabolic phenotyping.
Intervention: for 12 weeks, participants will receive either a diet optimal for MIR (high in mono-unsaturated fatty acids) or a diet optimal for LIR (high in protein and fiber, low in fat) with respect to changes in disposition index. Participants will be randomly allocated to one of the two diets. Detailed laboratory and daily life phenotyping will be done pre- and post intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimal diet | Experimental | Other: Optimal dietParticipants will follow a diet for a total duration of 12 weeks, optimal for their metabolic phenotype. For participants with muscle insulin resistance (MIR) this will be a diet high in monounsaturated fatty acids, for participants with liver insulin resistance (LIR) this will be a diet high in protein and fiber and low in fat. |
| Suboptimal diet | Experimental | Other: Suboptimal dietParticipants will follow a diet for a total duration of 12 weeks, suboptimal for their metabolic phenotype. For participants with liver insulin resistance (LIR) this will be a diet high in monounsaturated fatty acids, for participants with muscle insulin resistance (MIR) this will be a diet high in protein and fiber and low in fat. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI 25 to <40 kg/m2
- Predominantly muscle (MIR) or liver (LIR) insulin resistant
- Weight stability for at least 3 months (+/- 3 kg)
Key exclusion criteria (37 listed)
- Diseases
- Pre-diagnosis of type 1 or type 2 diabetes mellitus
- Renal or hepatic malfunctioning (pre-diagnosis or determined based on alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT) and creatinine values)
- Gastrointestinal diseases or abdominal surgery (allowed i.e.: appendectomy, cholecystectomy)
- Food allergies, intolerances (including gluten/lactose intolerance) and/or dietary restrictions interfering with the study (including special diets, vegetarians and eating disorders)
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 |
|---|---|---|
| Optimal dietBased on a 7-points OGTT, participants will be classified as MIR or LIR. The hypothesized optimal diet for MIR has a moderate fat content which is high in mono- unsaturated fatty acids (HMUFA) with a macronutrient breakdown of 38 E% from fat (20% MUFA, 10% polyunsaturated fatty acids (PUFA), 8% saturated fatty acids (SFA)), 48 E% from carbohydrates (CHO, 35% complex), and 14 E% from protein (35-40% plant protein). The hypothesized optimal diet for LIR is low in fat, high in protein (LFHP) and increased fiber with a macronutrient breakdown of <28 E% from fat (10% MUFA, 10% PUFA, 8% SFA), 48 E% from CHO (35% complex), and 24 E% from protein (35-40% plant protein), and an additional supplement of 6g of soluble fiber per day. Participants wil be randomly allocated to one of the two diets. | Other | Optimal diet |
| Suboptimal dietThe optimal diet for the other metabolic phenotype will be considered as "suboptimal"/ control diet. For the MIR phenotype this is the high protein, high fiber, low fat diet; for the LIR phenotype this is the high monounsaturated fatty acid diet. See the description above. | Other | Suboptimal diet |
Primary outcome
Disposition index
Time frame: Change from baseline at week 12 dietary intervention
The primary objective of this study is to establish the effect of a metabolically targeted, optimal versus suboptimal macronutrient manipulated 12-week dietary intervention on the change in disposition index, a composite marker of first phase insulin secretion and insulin sensitivity during a 2-hour 7-points oral glucose tolerance test (OGTT). Disposition index will be calculated as follows: [Insulin sensitivity index (ISI) * (AUC30 min insulin / AUC30 min glucose)], where AUC30 min is the area under the curve between 0 and 30 minutes of the OGTT for insulin (pmol/l) and glucose (mmol/l), respectively, and ISI is defined as: [10,000 ÷ square root of (fasting plasma glucose (mmol/l) x fasting insulin (pmol/l)) x (mean glucose (mmol/l) x mean insulin (pmol/l))]. Higher values represent a higher insulin sensitivity.
40 secondary outcomes
Mean 24h glucose concentrations
Time frame: Change from baseline at week 12 dietary intervention
Glucose incremental area under the curve (iAUC)
Time frame: Change from baseline at week 12 dietary intervention
The frequency and duration of hypo- and hyperglycemia
Time frame: Change from baseline at week 12 dietary intervention
Glucose tolerance
Time frame: Change from baseline at week 12 dietary intervention
Muscle insulin sensitivity
Time frame: Change from baseline at week 12 dietary intervention
Hepatic insulin sensitivity
Time frame: Change from baseline at week 12 dietary intervention
Insulin sensitivity
Time frame: Change from baseline at week 12 dietary intervention
Body composition
Time frame: Change from baseline at week 12 dietary intervention
Waist circumference
Time frame: Change from baseline at week 12 dietary intervention
Hip circumferences
Time frame: Change from baseline at week 12 dietary intervention
Body fat distribution
Time frame: Change from baseline at week 12 dietary intervention
Blood pressure
Time frame: Change from baseline at week 12 dietary intervention
Fasting circulating metabolic markers
Time frame: Change from baseline at week 12 dietary intervention
Fasting blood lipid spectrum
Time frame: Change from baseline at week 12 dietary intervention
Postprandial circulating metabolic markers
Time frame: Change from baseline at week 12 dietary intervention
Energy expenditure
Time frame: Change from baseline at week 12 dietary intervention
Substrate oxidation
Time frame: Change from baseline at week 12 dietary intervention
Fecal microbiota composition
Time frame: Change from baseline at week 12 dietary intervention
Oral microbiota composition
Time frame: Change from baseline at week 12 dietary intervention
Self-reported perceived stress
Time frame: Change from baseline at week 12 dietary intervention
Self-reported self efficacy in physical activity
Time frame: Change from baseline at week 12 dietary intervention
Self-reported sleep behaviour
Time frame: Change from baseline at week 12 dietary intervention
Self-reported sleep quality over a 1 month period
Time frame: Change from baseline at week 12 dietary intervention
Self-reported daytime sleepiness
Time frame: Change from baseline at week 12 dietary intervention
Self-reported fatigue
Time frame: Change from baseline at week 12 dietary intervention
Self-reported sedentary behaviour
Time frame: Change from baseline at week 12 dietary intervention
Self-reported physical activity
Time frame: Change from baseline at week 12 dietary intervention
Self-reported eating rate
Time frame: Change from baseline at week 12 dietary intervention
Self-reported intestinal health
Time frame: Change from baseline at week 12 dietary intervention
Self-reported quality of life
Time frame: Change from baseline at week 12 dietary intervention
Physical activity patterns
Time frame: Change from baseline at week 12 dietary intervention
Cognitive performance
Time frame: Change from baseline at week 12 dietary intervention
Subcutaneous adipose tissue biopsy
Time frame: Change from baseline at week 12 dietary intervention
Skeletal muscle biopsy
Time frame: Change from baseline at week 12 dietary intervention
Advanced glycation end-product (AGE) accumulation
Time frame: Change from baseline at week 12 dietary intervention
Fasting immune metabolism (PBMCs)
Time frame: Change from baseline at week 12 dietary intervention
Carotid artery reactivity
Time frame: Change from baseline at week 12 dietary intervention
Food preferences
Time frame: Change from baseline at week 12 dietary intervention
Intervention effects on all above outcomes within the LIR and MIR group.
Time frame: Change from baseline at week 12 dietary intervention
DNA analysis
Time frame: Baseline
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 14 Feb 2022.
- Derived from this study: PubMed 42191942Hoge A, Donneau AF, Dardenne N, Guillaume M, Afman LA, Feskens EJM, Goossens GH, Blaak EE. Differential associations of diet with hepatic and muscle insulin resistance: insights from an dietary pattern analysis in the PERSON study. Eur J Nutr. 2026 May 26;65(4):142. doi: 10.1007/s00394-026-03996-8.
- Derived from this study: PubMed 42097279Jardon KM, Umanets A, Venema K, Trouwborst I, Gijbels A, Hul GB, Siebelink E, Afman LA, Goossens GH, Blaak EE. Gut microbiota responses to isocaloric macronutrient modulation in tissue-specific insulin resistance: a secondary analysis of the PERSonalized glucose Optimization through Nutritional intervention (PERSON) randomized trial. Am J Clin Nutr. 2026 Jul;124(1):101340. doi: 10.1016/j.ajcnut.2026.101340. Epub 2026 May 5.
- Derived from this study: PubMed 40336254Jardon KM, Umanets A, Gijbels A, Trouwborst I, Hul GB, Siebelink E, Vliex LMM, Bastings JJAJ, Argamasilla R, Chenal E, Venema K, Afman LA, Goossens GH, Blaak EE. Distinct gut microbiota and metabolome features of tissue-specific insulin resistance in overweight and obesity. Gut Microbes. 2025 Dec;17(1):2501185. doi: 10.1080/19490976.2025.2501185. Epub 2025 May 7.
- Derived from this study: PubMed 38851634Gijbels A, Jardon KM, Trouwborst I, Manusama KC, Goossens GH, Blaak EE, Feskens EJ, Afman LA. Fasting and postprandial plasma metabolite responses to a 12-wk dietary intervention in tissue-specific insulin resistance: a secondary analysis of the PERSonalized glucose Optimization through Nutritional intervention (PERSON) randomized trial. Am J Clin Nutr. 2024 Aug;120(2):347-359. doi: 10.1016/j.ajcnut.2024.05.027. Epub 2024 Jun 6.
- Derived from this study: PubMed 38594756Trouwborst I, Jardon KM, Gijbels A, Hul G, Feskens EJM, Afman LA, Linge J, Goossens GH, Blaak EE. Body composition and body fat distribution in tissue-specific insulin resistance and in response to a 12-week isocaloric dietary macronutrient intervention. Nutr Metab (Lond). 2024 Apr 9;21(1):20. doi: 10.1186/s12986-024-00795-y.
- Derived from this study: PubMed 36599304Trouwborst I, Gijbels A, Jardon KM, Siebelink E, Hul GB, Wanders L, Erdos B, Peter S, Singh-Povel CM, de Vogel-van den Bosch J, Adriaens ME, Arts ICW, Thijssen DHJ, Feskens EJM, Goossens GH, Afman LA, Blaak EE. Cardiometabolic health improvements upon dietary intervention are driven by tissue-specific insulin resistance phenotype: A precision nutrition trial. Cell Metab. 2023 Jan 3;35(1):71-83.e5. doi: 10.1016/j.cmet.2022.12.002.
- Derived from this study: PubMed 34277687Gijbels A, Trouwborst I, Jardon KM, Hul GB, Siebelink E, Bowser SM, Yildiz D, Wanders L, Erdos B, Thijssen DHJ, Feskens EJM, Goossens GH, Afman LA, Blaak EE. The PERSonalized Glucose Optimization Through Nutritional Intervention (PERSON) Study: Rationale, Design and Preliminary Screening Results. Front Nutr. 2021 Jun 30;8:694568. doi: 10.3389/fnut.2021.694568. eCollection 2021.
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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.
Ellen E Blaak, Prof. principal investigator
Maastricht University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimal diet and Suboptimal diet in people with Obesity and Pre-diabetic, run by Maastricht University Medical Center at 2 sites 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 37 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 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Disposition index (time frame: Change from baseline at week 12 dietary intervention). 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 NCT03708419, which also lists 7 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 14 Feb 2022; AzTrials last refreshed its copy on 2 Nov 2026.