ObesityNCT04920409
Effect of an Antiinflammatory Diet on Postprandial Gene Expression of Mononuclear Cells of Adult Obese Women
A study testing FAWGT diet and Usual diet (UD) in people with Obesity, run by Universidad de Caldas at 1 site in Colombia.
Trial summary
Obesity is one of the major health problems worldwide. The consumption of healthy-dietary patterns can be difficult in some countries due to the availability of certain foods. Suggestion of alternative foods could be a necessity. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- FAWGT diet and Usual diet (UD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteColombia
- Study dates
- 6 Jan 2018to 18 Jun 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent
- Body mass index (BMI) ≥ 30 Kg/m^2.
- Clinical: hypertensive and dyslipidemic participants.
Who cannot join
- Age < 40 or > 65 years
- Patients unable to follow a protocol.
- Psychiatric diseases
- Renal Insufficiency
- Chronic Hepatopathy
- Active Malignancy
Show all 17Show fewer
- Chronic obstructive pulmonary disease
- Diseases of the digestive tract Endocrine disorders
- Smokers.
- Regular alcohol consumers.
- Participants who were in weight reduction programs
- Prescribed hypolipidaemic medication
- Prescribed anti-inflammatory medication
- Kidney or liver dysfunction.
- Diabetes or other endocrine disorders.
- Chronic inflammatory conditions.
- Patients participating in other Clinical trials (in the enrollment moment or 30 days prior).
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Clinica Comfamiliar Risaralda
Pereira, Risaralda Department, 16000
About this study
Obesity is one of the major health problems worldwide. The consumption of healthy-dietary patterns can be difficult in some countries due to the availability of certain foods. Suggestion of alternative foods could be a necessity. The purpose of this study was to evaluate the effect of a dietary pattern consisting of fruit, avocado, whole-grains and trout (FAWGT) on postprandial gene expression, insulinemia and lipemia in Colombian obese people.
Read the detailed description
A randomized controlled crossover study was conducted. Volunteers underwent to two dietary models for 8 weeks each, including a 2 weeks washout diet between them. The order in which they started the interventions was randomized following a computerized assignment list using Excel software (Microsoft Office 2015, Excel 2013).
The primary endpoint was the postprandial gene expression of nuclear factor kappa B subunit 1 (NFKB1) gene. Based on previous studies , 20 individuals had to be studied to detect a 0.2 difference in the expression of the NKKB1 gene between diets with 0.05 significance level and 80 percentage power (type II error Z 0.2), assuming a 10 percentage drop-out rate.
The recruitment of participants was carried out according to the following steps:
- Review of clinical histories of patients diagnosed with obesity, according to their Body Mass Index, ascribed to the chronic non-communicable diseases program of the Clinica Comfamiliar Risaralda in the city of Pereira Colombia.
- Telephone call to invite the participants who met the inclusion criteria to participate in the study.
- Appointment prior to the start of the study to take a blood sample to corroborate the inclusion criteria. With this sample the following tests were performed: blood glucose, lipid profile, thyroid stimulating hormone (TSH), C-reactive protein ( and complete blood count.
This process was carried out by personnel not involved in the research. The results obtained were compared with the clinical history.
The diets followed during the intervention periods were: (1) a diet consisting mainly of the consumption of fruit, avocado and other vegetables, whole grains and trout typical of the colombian coffee region (FAWGT) (experimental diet), and (2) the usual diet consumed by the participants in their normal lifestyle (UD).
At the beginning of the dietary intervention period, each participant was given an individualized food guide containing the suggested food group and portions, with a wide variety of foods allowed for greater adherence to the diet. In addition, specific times for consumption of the foods and precise instructions for the dietary intervention were given. In addition, the subjects were given a talk advising them how to quantify the portions, which would later be converted into grams according to the procedure described
The food portions were standardized with all the participants using synthetic models, adapted according to the Colombian nutritional guidelines, so that they could provide a more accurate report of the portions consumed during the intervention. In addition, a postprandial studies were carried out at the beginning of the study (pre-intervention) and another after 8 weeks of dietary intervention (post-intervention).
The participants were given an appointment at the health center at 7.00 am, after at least 12 hours of fasting and a 5 day abstinence from alcohol. They consumed a breakfast based on the same composition of the diet in which they were randomized for the dietary intervention period. The blood samples were obtained by veni-puncture at baseline and 4 hours after breakfast. During the postprandial period, the participants did not consume any more food, although they were allowed to drink water. The breakfasts were composed of the following foods: FAWGT diet; whole-grain arepa (with unrefined corn flour), cheese, oats, granadilla, mango, linseed, nuts, almonds, peanuts and yogurt. Usual diet; egg, cheese, butter, whole milk, traditional white arepa (with re-fined corn flour), traditional buñuelo (made from wheat flour with cheese), coffee and sugar.
Before starting the dietary intervention period (Pre-intervention), at the midpoint of the study (week 4) and at the end (week 8), all the participants completed three 24-hour recalls (2 non-consecutive weekdays and one weekend day) to obtain information about food, ingredients and preparations consumed in the same units of measurement (grams).
In addition, a weekly telephone call was made to answer any questions relating to the diet (recipes, menu and quantities) and to motivate adherence to the assigned dietary model.
Moreover, in week four of each intervention, the participants attended the hospital for an interview with the main researcher in order to take anthropometric measurements, evaluate the follow-up of the dietary instructions and answer any questions that may have arisen during the intervention, and motivate them to continue with the study. To collect the information on food consumption, formats and questionnaires previously published by the research group were used.
- Conditions
- Obesity
- Being tested
- FAWGT diet, Usual diet (UD)
- Keywords
- Obesity, Diet, Postprandial state, Gene expression, Inflammation, Lipemia, Insulinemia
- Medical subject headings
- Obesity, Inflammation, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAWGT dietOther
Composed of 15% protein, 55% CH and 30% fat of which < 10% was SFA, 14% MUFA and 6% PUFA in the overall total caloric content.
Usual diet (UD)Other
Consisted of 16% protein, 54% carbohydrates (CH) and 30% fat of which 15% was saturated fat (SFA), 10% monounsaturated fat (MUFA) and 5% polyunsaturated fat (PUFA)in relation to the total caloric content
| Study group | Role | What they receive |
|---|---|---|
| FAWGT Diet | Experimental | Composed of fruit, avocado, whole grains and trout Receives: Other: FAWGT diet |
| Usual diet (UD) | Active comparator | Based on the food which the participants usually consumed prior to the study in their normal lifestyle. Receives: Other: Usual diet (UD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative expression of the NFKB1 gene
RNA extraction from mononuclear cells, reverse transcription and DNA amplification in fasting and postprandial state.
Measured: 8 weeks
Relative expression of the Interleukin 6 (IL6) gene
RNA extraction from mononuclear cells, reverse transcription and DNA amplification in fasting and postprandial state.
Measured: 8 weeks
Relative expression of the tumoral necrosis factor (TNF) gene
RNA extraction from mononuclear cells, reverse transcription and DNA amplification in fasting and postprandial state.
Measured: 8 weeks
Relative expression of the Interleukin 1 B (IL1B) gene
RNA extraction from mononuclear cells, reverse transcription and DNA amplification in fasting and postprandial state..
Measured: 8 weeks
Relative expression of the matrix metallopeptidase 9 (MMP)) gene
RNA extraction from mononuclear cells, reverse transcription and DNA amplification in fasting and postprandial state.
Measured: 8 weeks
Relative expression of the nuclear factor, erythroid 2 like 2 (NFE2L2) gene
RNA extraction from mononuclear cells, reverse transcription and DNA amplification.
Measured: 8 weeks
Secondary outcomes (9)
Change from baseline of the gut microbiota
Stool deoxyribonucleic acid (DNA) extraction, library construction, sequencing and bioinformatic analysis.
Measured: 8 weeks
Change from baseline of DNA methylation pattern
Whole blood DNA extraction and Enzyme-Linked ImmunoSorbent Assay (ELISA)
Measured: 8 weeks
Triglycerides
Influence of diet on postprandial trygliceride
Measured: 8 weeks
Insulin
Influence of diet on postprandial insulinemia
Measured: 8 weeks
Total Cholesterol
Influence of diet on postprandial total Cholesterol
Measured: 8 weeks
LDL Cholesterol
Influence of diet on postprandial LDL Cholesterol
Measured: 8 weeks
HDL Cholesterol
Influence of diet on postprandial HDL Cholesterol
Measured: 8 weeks
VLDL Cholesterol
Influence of diet on postprandial VLDL Cholesterol
Measured: 8 weeks
C-reactive protein (CRP)
Influence of diet on postprandial CRP
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start6 Jan 2018
- Primary completion18 Jun 2018
- Study completion18 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Caldas
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Libre, Clínica Comfamiliar Risaralda
- Responsible party
- Principal investigator, Diana M Munoz, Universidad de Caldas
- Investigators
- Clara H Gonzalez Correa, Doctor, Study director, Universidad de CaldasDiana M Muñoz, PhD student, Principal investigator, Universidad de CaldasOriol A Rangel Zuñiga, Postdoctor, Principal investigator, Instituto Maimonides de Investigación Biomédica de CórdobaAntonio Camargo, Postdoctor, Principal investigator, Instituto Maimonides de Investigacion Biomedica de CordobaElcy Y Astudillo Muñoz, Doctor, Study chair, Universidad LibreGloria L Porras Hurtado, Postdoctor, Study chair, Clinica Comfamiliar RisaraldaMaite Sanchez Giraldo, PhD student, Study chair, Instituto Maimonides de Investigación Biomedica de Cordoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920409
- Sponsor's protocol ID
- 0406716
- Status last verified
- Jun 2021
- First submitted
- 25 May 2021
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hurt RT, Kulisek C, Buchanan LA, McClave SA. The obesity epidemic: challenges, health initiatives, and implications for gastroenterologists. Gastroenterol Hepatol (N Y). 2010 Dec;6(12):780-92.
PubMed 21301632Frigolet ME, Dong-Hoon K, Canizales-Quinteros S, Gutierrez-Aguilar R. Obesity, adipose tissue, and bariatric surgery. Bol Med Hosp Infant Mex. 2020;77(1):3-14. doi: 10.24875/BMHIM.19000115.
PubMed 32115585Fernemark H, Jaredsson C, Bunjaku B, Rosenqvist U, Nystrom FH, Guldbrand H. A randomized cross-over trial of the postprandial effects of three different diets in patients with type 2 diabetes. PLoS One. 2013 Nov 27;8(11):e79324. doi: 10.1371/journal.pone.0079324. eCollection 2013.
PubMed 24312178Koch W. Dietary Polyphenols-Important Non-Nutrients in the Prevention of Chronic Noncommunicable Diseases. A Systematic Review. Nutrients. 2019 May 9;11(5):1039. doi: 10.3390/nu11051039.
PubMed 31075905Lopez-Miranda J, Williams C, Lairon D. Dietary, physiological, genetic and pathological influences on postprandial lipid metabolism. Br J Nutr. 2007 Sep;98(3):458-73. doi: 10.1017/S000711450774268X.
PubMed 17705891Perez-Martinez P, Ordovas JM, Garcia-Rios A, Delgado-Lista J, Delgado-Casado N, Cruz-Teno C, Camargo A, Yubero-Serrano EM, Rodriguez F, Perez-Jimenez F, Lopez-Miranda J. Consumption of diets with different type of fat influences triacylglycerols-rich lipoproteins particle number and size during the postprandial state. Nutr Metab Cardiovasc Dis. 2011 Jan;21(1):39-45. doi: 10.1016/j.numecd.2009.07.008. Epub 2009 Oct 9.
PubMed 19819118Uusitupa M, Hermansen K, Savolainen MJ, Schwab U, Kolehmainen M, Brader L, Mortensen LS, Cloetens L, Johansson-Persson A, Onning G, Landin-Olsson M, Herzig KH, Hukkanen J, Rosqvist F, Iggman D, Paananen J, Pulkki KJ, Siloaho M, Dragsted L, Barri T, Overvad K, Bach Knudsen KE, Hedemann MS, Arner P, Dahlman I, Borge GI, Baardseth P, Ulven SM, Gunnarsdottir I, Jonsdottir S, Thorsdottir I, Oresic M, Poutanen KS, Riserus U, Akesson B. Effects of an isocaloric healthy Nordic diet on insulin sensitivity, lipid profile and inflammation markers in metabolic syndrome -- a randomized study (SYSDIET). J Intern Med. 2013 Jul;274(1):52-66. doi: 10.1111/joim.12044. Epub 2013 Mar 2.
PubMed 23398528Gomez-Marin B, Gomez-Delgado F, Lopez-Moreno J, Alcala-Diaz JF, Jimenez-Lucena R, Torres-Pena JD, Garcia-Rios A, Ortiz-Morales AM, Yubero-Serrano EM, Del Mar Malagon M, Lai CQ, Delgado-Lista J, Ordovas JM, Lopez-Miranda J, Perez-Martinez P. Long-term consumption of a Mediterranean diet improves postprandial lipemia in patients with type 2 diabetes: the Cordioprev randomized trial. Am J Clin Nutr. 2018 Nov 1;108(5):963-970. doi: 10.1093/ajcn/nqy144.
PubMed 30475968
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Antiinflammatory Diet on Postprandial Gene Expression of Mononuclear Cells of Adult Obese Women
- ClinicalTrials.gov ID
- NCT04920409
- Acronym / sponsor ID
- 0406716
- Conditions
- Obesity
- Keywords
- Obesity, Diet, Postprandial state, Gene expression, Inflammation, Lipemia, Insulinemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Universidad de CaldasUniversity, hospital or other
- Collaborators
- Universidad Libre, Clínica Comfamiliar Risaralda
- Study start
- 6 Jan 2018 (actual)
- Primary completion
- 18 Jun 2018 (actual)
- Study completion
- 18 Jun 2018 (actual)
- First posted
- 9 Jun 2021 (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.
Obesity is one of the major health problems worldwide. The consumption of healthy-dietary patterns can be difficult in some countries due to the availability of certain foods. Suggestion of alternative foods could be a necessity. The purpose of this study was to evaluate the effect of a dietary pattern consisting of fruit, avocado, whole-grains and trout (FAWGT) on postprandial gene expression, insulinemia and lipemia in Colombian obese people.
Detailed description
A randomized controlled crossover study was conducted. Volunteers underwent to two dietary models for 8 weeks each, including a 2 weeks washout diet between them. The order in which they started the interventions was randomized following a computerized assignment list using Excel software (Microsoft Office 2015, Excel 2013).
The primary endpoint was the postprandial gene expression of nuclear factor kappa B subunit 1 (NFKB1) gene. Based on previous studies , 20 individuals had to be studied to detect a 0.2 difference in the expression of the NKKB1 gene between diets with 0.05 significance level and 80 percentage power (type II error Z 0.2), assuming a 10 percentage drop-out rate.
The recruitment of participants was carried out according to the following steps:
- Review of clinical histories of patients diagnosed with obesity, according to their Body Mass Index, ascribed to the chronic non-communicable diseases program of the Clinica Comfamiliar Risaralda in the city of Pereira Colombia.
- Telephone call to invite the participants who met the inclusion criteria to participate in the study.
- Appointment prior to the start of the study to take a blood sample to corroborate the inclusion criteria. With this sample the following tests were performed: blood glucose, lipid profile, thyroid stimulating hormone (TSH), C-reactive protein ( and complete blood count.
This process was carried out by personnel not involved in the research. The results obtained were compared with the clinical history.
The diets followed during the intervention periods were: (1) a diet consisting mainly of the consumption of fruit, avocado and other vegetables, whole grains and trout typical of the colombian coffee region (FAWGT) (experimental diet), and (2) the usual diet consumed by the participants in their normal lifestyle (UD).
At the beginning of the dietary intervention period, each participant was given an individualized food guide containing the suggested food group and portions, with a wide variety of foods allowed for greater adherence to the diet. In addition, specific times for consumption of the foods and precise instructions for the dietary intervention were given. In addition, the subjects were given a talk advising them how to quantify the portions, which would later be converted into grams according to the procedure described
The food portions were standardized with all the participants using synthetic models, adapted according to the Colombian nutritional guidelines, so that they could provide a more accurate report of the portions consumed during the intervention. In addition, a postprandial studies were carried out at the beginning of the study (pre-intervention) and another after 8 weeks of dietary intervention (post-intervention).
The participants were given an appointment at the health center at 7.00 am, after at least 12 hours of fasting and a 5 day abstinence from alcohol. They consumed a breakfast based on the same composition of the diet in which they were randomized for the dietary intervention period. The blood samples were obtained by veni-puncture at baseline and 4 hours after breakfast. During the postprandial period, the participants did not consume any more food, although they were allowed to drink water. The breakfasts were composed of the following foods: FAWGT diet; whole-grain arepa (with unrefined corn flour), cheese, oats, granadilla, mango, linseed, nuts, almonds, peanuts and yogurt. Usual diet; egg, cheese, butter, whole milk, traditional white arepa (with re-fined corn flour), traditional buñuelo (made from wheat flour with cheese), coffee and sugar.
Before starting the dietary intervention period (Pre-intervention), at the midpoint of the study (week 4) and at the end (week 8), all the participants completed three 24-hour recalls (2 non-consecutive weekdays and one weekend day) to obtain information about food, ingredients and preparations consumed in the same units of measurement (grams).
In addition, a weekly telephone call was made to answer any questions relating to the diet (recipes, menu and quantities) and to motivate adherence to the assigned dietary model.
Moreover, in week four of each intervention, the participants attended the hospital for an interview with the main researcher in order to take anthropometric measurements, evaluate the follow-up of the dietary instructions and answer any questions that may have arisen during the intervention, and motivate them to continue with the study. To collect the information on food consumption, formats and questionnaires previously published by the research group were used.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FAWGT Diet | Experimental | Other: FAWGT dietComposed of fruit, avocado, whole grains and trout |
| Usual diet (UD) | Active comparator | Other: Usual diet (UD)Based on the food which the participants usually consumed prior to the study in their normal lifestyle. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed consent
- Body mass index (BMI) ≥ 30 Kg/m^2.
- Clinical: hypertensive and dyslipidemic participants.
Key exclusion criteria (17 listed)
- Age < 40 or > 65 years
- Patients unable to follow a protocol.
- Psychiatric diseases
- Renal Insufficiency
- Chronic Hepatopathy
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 |
|---|---|---|
| FAWGT dietComposed of 15% protein, 55% CH and 30% fat of which < 10% was SFA, 14% MUFA and 6% PUFA in the overall total caloric content. | Other | FAWGT Diet |
| Usual diet (UD)Consisted of 16% protein, 54% carbohydrates (CH) and 30% fat of which 15% was saturated fat (SFA), 10% monounsaturated fat (MUFA) and 5% polyunsaturated fat (PUFA)in relation to the total caloric content | Other | Usual diet (UD) |
Primary outcome
Relative expression of the NFKB1 gene
Time frame: 8 weeks
RNA extraction from mononuclear cells, reverse transcription and DNA amplification in fasting and postprandial state.
Relative expression of the Interleukin 6 (IL6) gene
Time frame: 8 weeks
RNA extraction from mononuclear cells, reverse transcription and DNA amplification in fasting and postprandial state.
Relative expression of the tumoral necrosis factor (TNF) gene
Time frame: 8 weeks
RNA extraction from mononuclear cells, reverse transcription and DNA amplification in fasting and postprandial state.
Relative expression of the Interleukin 1 B (IL1B) gene
Time frame: 8 weeks
RNA extraction from mononuclear cells, reverse transcription and DNA amplification in fasting and postprandial state..
Relative expression of the matrix metallopeptidase 9 (MMP)) gene
Time frame: 8 weeks
RNA extraction from mononuclear cells, reverse transcription and DNA amplification in fasting and postprandial state.
Relative expression of the nuclear factor, erythroid 2 like 2 (NFE2L2) gene
Time frame: 8 weeks
RNA extraction from mononuclear cells, reverse transcription and DNA amplification.
9 secondary outcomes
Change from baseline of the gut microbiota
Time frame: 8 weeks
Change from baseline of DNA methylation pattern
Time frame: 8 weeks
Triglycerides
Time frame: 8 weeks
Insulin
Time frame: 8 weeks
Total Cholesterol
Time frame: 8 weeks
LDL Cholesterol
Time frame: 8 weeks
HDL Cholesterol
Time frame: 8 weeks
VLDL Cholesterol
Time frame: 8 weeks
C-reactive protein (CRP)
Time frame: 8 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 9 Jun 2021.
- Background: PubMed 21301632Hurt RT, Kulisek C, Buchanan LA, McClave SA. The obesity epidemic: challenges, health initiatives, and implications for gastroenterologists. Gastroenterol Hepatol (N Y). 2010 Dec;6(12):780-92.
- Background: PubMed 32115585Frigolet ME, Dong-Hoon K, Canizales-Quinteros S, Gutierrez-Aguilar R. Obesity, adipose tissue, and bariatric surgery. Bol Med Hosp Infant Mex. 2020;77(1):3-14. doi: 10.24875/BMHIM.19000115.
- Background: PubMed 24312178Fernemark H, Jaredsson C, Bunjaku B, Rosenqvist U, Nystrom FH, Guldbrand H. A randomized cross-over trial of the postprandial effects of three different diets in patients with type 2 diabetes. PLoS One. 2013 Nov 27;8(11):e79324. doi: 10.1371/journal.pone.0079324. eCollection 2013.
- Background: PubMed 31075905Koch W. Dietary Polyphenols-Important Non-Nutrients in the Prevention of Chronic Noncommunicable Diseases. A Systematic Review. Nutrients. 2019 May 9;11(5):1039. doi: 10.3390/nu11051039.
- Background: PubMed 17705891Lopez-Miranda J, Williams C, Lairon D. Dietary, physiological, genetic and pathological influences on postprandial lipid metabolism. Br J Nutr. 2007 Sep;98(3):458-73. doi: 10.1017/S000711450774268X.
- Background: PubMed 19819118Perez-Martinez P, Ordovas JM, Garcia-Rios A, Delgado-Lista J, Delgado-Casado N, Cruz-Teno C, Camargo A, Yubero-Serrano EM, Rodriguez F, Perez-Jimenez F, Lopez-Miranda J. Consumption of diets with different type of fat influences triacylglycerols-rich lipoproteins particle number and size during the postprandial state. Nutr Metab Cardiovasc Dis. 2011 Jan;21(1):39-45. doi: 10.1016/j.numecd.2009.07.008. Epub 2009 Oct 9.
- Background: PubMed 23398528Uusitupa M, Hermansen K, Savolainen MJ, Schwab U, Kolehmainen M, Brader L, Mortensen LS, Cloetens L, Johansson-Persson A, Onning G, Landin-Olsson M, Herzig KH, Hukkanen J, Rosqvist F, Iggman D, Paananen J, Pulkki KJ, Siloaho M, Dragsted L, Barri T, Overvad K, Bach Knudsen KE, Hedemann MS, Arner P, Dahlman I, Borge GI, Baardseth P, Ulven SM, Gunnarsdottir I, Jonsdottir S, Thorsdottir I, Oresic M, Poutanen KS, Riserus U, Akesson B. Effects of an isocaloric healthy Nordic diet on insulin sensitivity, lipid profile and inflammation markers in metabolic syndrome -- a randomized study (SYSDIET). J Intern Med. 2013 Jul;274(1):52-66. doi: 10.1111/joim.12044. Epub 2013 Mar 2.
- Background: PubMed 30475968Gomez-Marin B, Gomez-Delgado F, Lopez-Moreno J, Alcala-Diaz JF, Jimenez-Lucena R, Torres-Pena JD, Garcia-Rios A, Ortiz-Morales AM, Yubero-Serrano EM, Del Mar Malagon M, Lai CQ, Delgado-Lista J, Ordovas JM, Lopez-Miranda J, Perez-Martinez P. Long-term consumption of a Mediterranean diet improves postprandial lipemia in patients with type 2 diabetes: the Cordioprev randomized trial. Am J Clin Nutr. 2018 Nov 1;108(5):963-970. doi: 10.1093/ajcn/nqy144.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Clara H Gonzalez Correa, Doctor study director
Universidad de Caldas
Diana M Muñoz, PhD student principal investigator
Universidad de Caldas
Oriol A Rangel Zuñiga, Postdoctor principal investigator
Instituto Maimonides de Investigación Biomédica de Córdoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAWGT diet and Usual diet (UD) in people with Obesity, run by Universidad de Caldas at 1 site in Colombia.
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 17 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 9 Jun 2021. 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 Colombia. 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?
Relative expression of the NFKB1 gene (time frame: 8 weeks). The study lists 6 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 NCT04920409, which also lists 8 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 9 Jun 2021.