DyslipidemiasNCT05210023
Nutrigenetic Intervention on Blood Lipid Markers and Body Composition of Adults With Overweight and Obesity
A study testing NUTRIGENETIC DIET INTERVENTION and CONVENTIONAL DIET INTERVENTION in people with Dyslipidemias and Overweight and Obesity, run by Instituto Tecnológico y de Estudios Superiores de Occidente at 1 site in Mexico.
Trial summary
Obesity is defined as the accumulation of excessive fat, attributed to the maintenance of a positive energy imbalance between calorie intake and expenditure. Obesity contributes to the development of many comorbidities such as type 2 diabetes, cardiovascular diseases, hypertension, metabolic syndrome, and… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Dyslipidemias, Overweight and Obesity
- What is being tested?
- NUTRIGENETIC DIET INTERVENTION and CONVENTIONAL DIET INTERVENTION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteMexico
- Study dates
- 9 Jun 2021to 22 Dec 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women
- 18-50 years old
- Mexican- Mexican ancestry (3 generations)
- Live in Guadalajara, Jalisco or metropolitan area.
- Being overweight or obese BMI 25> 40
- Waist circumference:
- Women> 80 cm, Men> 94 cm.
- -Availability to attend virtual nutritional consultations
Who cannot join
- Not meeting the inclusion criteria.
- Pregnancy or breastfeeding
- Gastrointestinal disorders
- Endocrinopathies
- Cardiovascular events
- Diagnosed psychiatric illnesses.
Show all 10Show fewer
- Diagnosed diabetes
- Take lipid-lowering drugs
- Autoimmune diseases.
- Covid +
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Institute of Translational Nutrigenetics and Nutrigenomics, Department of Molecular Biology and Genomics, Health Sciences University Center, University of Guadalajara,
Guadalajara, Jalisco, 44340
About this study
Official title: Effect of a Nutrigenetic Intervention on Blood Lipid Markers and Body Composition of Adults With Overweight and Obesity
Obesity is defined as the accumulation of excessive fat, attributed to the maintenance of a positive energy imbalance between calorie intake and expenditure. Obesity contributes to the development of many comorbidities such as type 2 diabetes, cardiovascular diseases, hypertension, metabolic syndrome, and dyslipidemias, among others. Dyslipidemias indicate a high concentration of lipids in the blood. Dyslipidemias cause more than 4 million premature deaths per year.
The pathogenesis of obesity is complex as it involves environmental, sociocultural, physiological, medical, behavioral, genetic, epigenetic, and many other factors. On the other hand, the causes of dyslipidemias can be: genetic / hereditary (primary dyslipidemias) or an inadequate lifestyle (secondary dyslipidemias).
Read more
Sufficient evidence indicates that lifestyle, mainly diet, plays a decisive role in the development of diseases such as obesity and dyslipidemias, in addition to that, recent research shows the importance of individual genetic predisposition to suffer from diseases. Data based on genome-wide association studies suggest a genetic predisposition for obesity and dyslipidemias with identification of various genes and genetic variations associated with these conditions. In this sense, the postulates of nutrigenetics as applied science are emphasized, since it states that food components can act on the human genome, directly or indirectly, to alter the expression of genes and gene products; diet can potentially compensate or accentuate the effects of genetic polymorphisms; and the consequences of a certain diet depend on the balance of health and disease states and the genetic background of an individual.
Therefore, when advising a change in diet and lifestyle as prevention and as part of the treatment for obesity and dyslipidemias, it is considered that a nutrigenetic intervention, that is, the administration of a diet designed according to genotypic characteristics and personal phenotypic, will have a much greater positive impact on the health status of people with detected genetic variations that make them susceptible to these pathologies.
For this reason, the implementation of nutrigenetic interventions could be a timely and successful avant-garde treatment to mitigate various cardiometabolic diseases such as dyslipidemias and others that are highly prevalent worldwide.
Read the detailed description
After the selection of the population, the patients undergo a molecular diagnosis: DNA will be extracted from peripheral blood with the High Pure PCR (Polymerase Chain Reaction) Template Preparation Kit (Roche). Then certain polymorphisms will be determined by allelic discrimination with TaqMan® probes with real-time PCR.
The polymorphisms under study will be the following:
ABCA1 (ATP-binding cassette transporter ABCA1) rs9282541 PPARG (Peroxisome Proliferator Activated Receptor Gamma) rs1801282 LIPC (hepatic lipase) rs1800588 CETP (Cholesteryl ester transfer protein) rs708272 LPL (Lipoprotein lipase) rs13702 FABP2 (fatty acid binding protein 2) rs1799883 APOA5 (Apolipoprotein A-V) rs662799 APOC3 (Apolipoprotein C-III) rs5128 APOA1 (Apolipoprotein A-I) rs670 APOE (Apolipoprotein E) rs429358 and rs7412
Patients will be randomized into two different treatment groups. Randomization will be stratified according to age, BMI and sex. The allocation ratio will be 1: 1 and parallel intervention.Then, trained nutritionists will deliver the intervention according to the patient group and they will be followed-up for 8 weeks, which includes 3 face-to-face evaluations (baseline, 1st month and final) and 5 remote consultations, via zoom, every 15 days
Interventions will be provided as follows:
NUTRIGENETIC DIET INTERVENTION Weekly, personalized meal plans (menus) will be provided, prepared based on the anthropometric needs of the patients, with a caloric reduction (-500 kcal). These weekly menus (Sunday to Monday) consist of 5 meal times (breakfast, snack, lunch, snack and dinner). The distribution of the macronutrients: carbohydrates, proteins and fats, as well as the percentages of polyunsaturated, monounsaturated and saturated fatty acids, will be established according to certain nutrigenetic recommendations identified in the reference bibliography.
CONVENTIONAL DIET INTERVENTION Weekly, personalized meal plans (menus) will be provided, prepared based on the anthropometric needs of the patients, with a caloric reduction (-500 kcal). These weekly menus (Sunday to Monday) consist of 5 meal times (breakfast, snack, lunch, snack and dinner). The distribution of the macronutrients: carbohydrates, proteins and fats, as well as the percentages of polyunsaturated, monounsaturated and saturated fatty acids, will be in accordance with the recommendations made by the WHO (World Health Organization), the AHA (American Heart Association) and the NOM (Official Mexican Standards) for the treatment of obesity and dyslipidemias
The 3 face-to-face evaluations (baseline, 1st month, final) will include anthropometric and biochemical evaluations. Therefore, the following criteria will be measured:
Weight (kg) Height (cm) BMI(kg/m2) Waist circumference and hip circumference (cm) Blood pressure Body composition determination
Blood will be obtained from the antecubital vein, it will be centrifuged to obtain the serum and later it will determine:
Glucose (mg / dL) Total cholesterol (mg / dL) Triglycerides (mg / dL) HDL-c (mg / dL) LDL-c (mg / dL) VLDL-c (mg / dL) Insulin (microIU/mL) C-reactive protein (mg/L) Interleukins, among other parameters
Every 15 days there will be virtual remote consultations, through the zoom platform. In these sessions, the nutritional clinical history and various medical and dietary questionnaires will be applied to evaluate secondary results. In addition, a new food plan will be delivered, according to the needs of the participant and taking into account the characteristics of the experimental treatment to which they belong.
This research will be conducted at The Institute of Translational Nutrigenetics and Nutrigenomics, Department of Molecular Biology and Genomics, Health Sciences University Center, University of Guadalajara, Guadalajara, Mexico
- Conditions
- Dyslipidemias, Overweight and Obesity
- Being tested
- NUTRIGENETIC DIET INTERVENTION, CONVENTIONAL DIET INTERVENTION
- Keywords
- nutrigenetic, polymorphisms, dietetic intervention, lipid levels
- Medical subject headings
- Dyslipidemias, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NUTRIGENETIC DIET INTERVENTIONOther
Also called Nutrigenetic diet group
Weekly, personalized meal plans (menus) will be provided, prepared based on the anthropometric needs of the patients, with a caloric reduction (-500 kcal). These weekly menus (Sunday to Monday) consist of 5 meal times (breakfast, snack, lunch, snack and dinner). The distribution of the macronutrients: carbohydrates, proteins and fats, as well as the percentages of polyunsaturated, monounsaturated and saturated fatty acids, will be established according to certain nutrigenetic recommendations identified in the reference bibliography.
Participants included in this group will receive remote (virtual) nutritional counseling every 15 days.
CONVENTIONAL DIET INTERVENTIONOther
Also called Conventional diet group
Weekly, personalized meal plans (menus) will be provided, prepared based on the anthropometric needs of the patients, with a caloric reduction (-500 kcal). These weekly menus (Sunday to Monday) consist of 5 meal times (breakfast, snack, lunch, snack and dinner). The distribution of the macronutrients: carbohydrates, proteins and fats, as well as the percentages of polyunsaturated, monounsaturated and saturated fatty acids, will be in accordance with the recommendations made by the WHO (World Health Organization), the AHA (American heart association) and the NOM (Official Mexican Standards) for the treatment of obesity and dyslipidemias.
Participants included in this group will receive remote (virtual) nutritional counseling every 15 days.
| Study group | Role | What they receive |
|---|---|---|
| Nutrigenetic Diet Group | Experimental | Participants randomly included in this group will receive nutrigenetic menus, i.e., considering the genotypes of the 11 variants analyzed. Receives: Other: NUTRIGENETIC DIET INTERVENTION |
| Conventional Diet Group | Experimental | Participants randomly included in this group will receive menus prepared following the international conventional guidelines set out by the WHO, AHA and Official Mexican Standards (NOM) for the treatment of obesity and dyslipidemia. Receives: Other: CONVENTIONAL DIET INTERVENTION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid profile change
Measurements of total cholesterol, LDL cholesterol, VLDL cholesterol, HDL cholesterol, and triglycerides will be evaluated to assess lipid profile change.
Measured: Baseline, week 4, week 8
Secondary outcomes (15)
Body composition change
Body fat mass (% BFM), body fat percentage (%BF) and skeletal muscle mass (% SMM) will be evaluated to assess body composition change. Measurements will be assessed using multifrequency bioelectrical impedance analysis (BIA)
Measured: Baseline, week 4, week 8
Visceral fat index change
Visceral fat index change will be evaluated to assess body composition change and fat loss. Measurement will be assessed using multifrequency bioelectrical impedance analysis (BIA)
Measured: Baseline, week 4, week 8
Body Weight change
Measurement of body weight (kg) will be evaluated to assess anthropometric change.
Measured: Baseline, week 4, week 8
Anthropometric measurements change
Waist circumference (cm) and hip circumference (cm) will be evaluated to assess anthropometric change.
Measured: Baseline, week 4, week 8
Body Mass Index (BMI) change
Body Mass Index (BMI) allows the identification of overweight and obesity in adults. Weight and height will be combined to report BMI in (kg/m^2)
Measured: Baseline, week 4, week 8
tumor Necrosis factor- alfa (TNF-alfa)
Change in TNF-alfa (pg/ml) will be evaluated as a marker of inflammation
Measured: Baseline, week 4, week 8
C-reactive protein (CRP)
Change in C-reactive protein (CRP)( mg/L) will be evaluated as a marker of inflammation
Measured: Baseline, week 4, week 8
Interleukins levels
Determination of serum levels of Interleukin (IL) 6, IL1, IL10 (pg/ml) will be evaluated as a markers of inflammation
Measured: Baseline, week 4, week 8
Change in glucose
Measuring glucose levels will determine changes in this parameter
Measured: Baseline, week 4, week 8
Change in blood pressure
Systolic and diastolic pressure measurement will determine changes in blood pressure
Measured: Baseline, week 4, week 8
Adherence to nutritional intervention
It will be evaluated through changes in food consumption (food frequency questionnaire)
Measured: Week 4, week 8
Change in food intake
Change in food intake using Food Frequency Questionnaire
Measured: Baseline, Week 4, week 8
Change in physical activity practice
Change in physical activity practice using International Physical Activity Questionnaire - Short Form
Measured: Baseline, week 8
Change in insulin level
Measurement of insulin levels will determine changes in this parameter (microIU/ml)
Measured: Baseline, week 4, week 8
Insulin Resistance (HOMA-IR)
Insulin resistance will be determined using HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) fasting serum glucose (mg/dL) x insulin (mIU /L) / 405
Measured: Baseline, week 4, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start9 Jun 2021
- Primary completion22 Dec 2021
- Study completion22 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiasStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled clinical trial, parallel, with 2 study groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Tecnológico y de Estudios Superiores de Occidente
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Tecnológico de Tepic, University of Guadalajara
- Responsible party
- Sponsor
- Investigators
- Edgar J Mendivil, PhD, Study director, Instituto Tecnológico y de Estudios Superiores de Occidente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210023
- Sponsor's protocol ID
- NUTRIGENETIC_INTERV07
- Status last verified
- Jan 2022
- First submitted
- 31 Dec 2021
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All information provided by participant is strictly confidential, will be used only by the project's research team and will not be available for any other purpose. The results obtained from this study will be published for scientific purposes but the confidentiality of the participants will never be violated. The information or evidence obtained will be eliminated after fulfilling the scientific purposes for which this intervention was proposed.
Publications
Barrea L, Annunziata G, Bordoni L, Muscogiuri G, Colao A, Savastano S; Obesity Programs of nutrition, Education, Research and Assessment (OPERA) Group. Nutrigenetics-personalized nutrition in obesity and cardiovascular diseases. Int J Obes Suppl. 2020 Jul;10(1):1-13. doi: 10.1038/s41367-020-0014-4. Epub 2020 Jul 20.
PubMed 32714508Corella D, Ordovas JM. Interactions between dietary n-3 fatty acids and genetic variants and risk of disease. Br J Nutr. 2012 Jun;107 Suppl 2(0 2):S271-83. doi: 10.1017/S0007114512001651.
PubMed 22591901de Luis D, Izaola O, Primo D, Aller R. Role of rs670 variant of APOA1 gene on metabolic response after a high fat vs. a low fat hypocaloric diets in obese human subjects. J Diabetes Complications. 2019 Mar;33(3):249-254. doi: 10.1016/j.jdiacomp.2018.10.015. Epub 2018 Nov 3.
PubMed 30467071Fall T, Mendelson M, Speliotes EK. Recent Advances in Human Genetics and Epigenetics of Adiposity: Pathway to Precision Medicine? Gastroenterology. 2017 May;152(7):1695-1706. doi: 10.1053/j.gastro.2017.01.054. Epub 2017 Feb 15.
PubMed 28214526Hannon BA, Khan NA, Teran-Garcia M. Nutrigenetic Contributions to Dyslipidemia: A Focus on Physiologically Relevant Pathways of Lipid and Lipoprotein Metabolism. Nutrients. 2018 Oct 2;10(10):1404. doi: 10.3390/nu10101404.
PubMed 30279335Sanchez-Moreno C, Ordovas JM, Smith CE, Baraza JC, Lee YC, Garaulet M. APOA5 gene variation interacts with dietary fat intake to modulate obesity and circulating triglycerides in a Mediterranean population. J Nutr. 2011 Mar;141(3):380-5. doi: 10.3945/jn.110.130344. Epub 2011 Jan 5.
PubMed 21209257Xu M, Ng SS, Bray GA, Ryan DH, Sacks FM, Ning G, Qi L. Dietary Fat Intake Modifies the Effect of a Common Variant in the LIPC Gene on Changes in Serum Lipid Concentrations during a Long-Term Weight-Loss Intervention Trial. J Nutr. 2015 Jun;145(6):1289-94. doi: 10.3945/jn.115.212514. Epub 2015 Apr 29.
PubMed 25926410Zhang X, Qi Q, Bray GA, Hu FB, Sacks FM, Qi L. APOA5 genotype modulates 2-y changes in lipid profile in response to weight-loss diet intervention: the Pounds Lost Trial. Am J Clin Nutr. 2012 Oct;96(4):917-22. doi: 10.3945/ajcn.112.040907. Epub 2012 Aug 22.
PubMed 22914552AlSaleh A, O'Dell SD, Frost GS, Griffin BA, Lovegrove JA, Jebb SA, Sanders TAB. Interaction of PPARG Pro12Ala with dietary fat influences plasma lipids in subjects at cardiometabolic risk. J Lipid Res. 2011 Dec;52(12):2298-2303. doi: 10.1194/jlr.P019281. Epub 2011 Sep 23.
PubMed 21949049
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Nutrigenetic Intervention on Blood Lipid Markers and Body Composition of Adults With Overweight and Obesity
- ClinicalTrials.gov ID
- NCT05210023
- Acronym / sponsor ID
- NUTRIGENETIC_INTERV07
- Conditions
- Dyslipidemias, Overweight and Obesity
- Keywords
- nutrigenetic, polymorphisms, dietetic intervention, lipid levels
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Instituto Tecnológico y de Estudios Superiores de OccidenteUniversity, hospital or other
- Collaborators
- Instituto Tecnológico de Tepic, University of Guadalajara
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 22 Dec 2021 (actual)
- First posted
- 27 Jan 2022 (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 defined as the accumulation of excessive fat, attributed to the maintenance of a positive energy imbalance between calorie intake and expenditure. Obesity contributes to the development of many comorbidities such as type 2 diabetes, cardiovascular diseases, hypertension, metabolic syndrome, and dyslipidemias, among others. Dyslipidemias indicate a high concentration of lipids in the blood. Dyslipidemias cause more than 4 million premature deaths per year.
The pathogenesis of obesity is complex as it involves environmental, sociocultural, physiological, medical, behavioral, genetic, epigenetic, and many other factors. On the other hand, the causes of dyslipidemias can be: genetic / hereditary (primary dyslipidemias) or an inadequate lifestyle (secondary dyslipidemias).
Sufficient evidence indicates that lifestyle, mainly diet, plays a decisive role in the development of diseases such as obesity and dyslipidemias, in addition to that, recent research shows the importance of individual genetic predisposition to suffer from diseases. Data based on genome-wide association studies suggest a genetic predisposition for obesity and dyslipidemias with identification of various genes and genetic variations associated with these conditions. In this sense, the postulates of nutrigenetics as applied science are emphasized, since it states that food components can act on the human genome, directly or indirectly, to alter the expression of genes and gene products; diet can potentially compensate or accentuate the effects of genetic polymorphisms; and the consequences of a certain diet depend on the balance of health and disease states and the genetic background of an individual.
Therefore, when advising a change in diet and lifestyle as prevention and as part of the treatment for obesity and dyslipidemias, it is considered that a nutrigenetic intervention, that is, the administration of a diet designed according to genotypic characteristics and personal phenotypic, will have a much greater positive impact on the health status of people with detected genetic variations that make them susceptible to these pathologies.
For this reason, the implementation of nutrigenetic interventions could be a timely and successful avant-garde treatment to mitigate various cardiometabolic diseases such as dyslipidemias and others that are highly prevalent worldwide.
Detailed description
After the selection of the population, the patients undergo a molecular diagnosis: DNA will be extracted from peripheral blood with the High Pure PCR (Polymerase Chain Reaction) Template Preparation Kit (Roche). Then certain polymorphisms will be determined by allelic discrimination with TaqMan® probes with real-time PCR.
The polymorphisms under study will be the following:
ABCA1 (ATP-binding cassette transporter ABCA1) rs9282541 PPARG (Peroxisome Proliferator Activated Receptor Gamma) rs1801282 LIPC (hepatic lipase) rs1800588 CETP (Cholesteryl ester transfer protein) rs708272 LPL (Lipoprotein lipase) rs13702 FABP2 (fatty acid binding protein 2) rs1799883 APOA5 (Apolipoprotein A-V) rs662799 APOC3 (Apolipoprotein C-III) rs5128 APOA1 (Apolipoprotein A-I) rs670 APOE (Apolipoprotein E) rs429358 and rs7412
Patients will be randomized into two different treatment groups. Randomization will be stratified according to age, BMI and sex. The allocation ratio will be 1: 1 and parallel intervention.Then, trained nutritionists will deliver the intervention according to the patient group and they will be followed-up for 8 weeks, which includes 3 face-to-face evaluations (baseline, 1st month and final) and 5 remote consultations, via zoom, every 15 days
Interventions will be provided as follows:
NUTRIGENETIC DIET INTERVENTION Weekly, personalized meal plans (menus) will be provided, prepared based on the anthropometric needs of the patients, with a caloric reduction (-500 kcal). These weekly menus (Sunday to Monday) consist of 5 meal times (breakfast, snack, lunch, snack and dinner). The distribution of the macronutrients: carbohydrates, proteins and fats, as well as the percentages of polyunsaturated, monounsaturated and saturated fatty acids, will be established according to certain nutrigenetic recommendations identified in the reference bibliography.
CONVENTIONAL DIET INTERVENTION Weekly, personalized meal plans (menus) will be provided, prepared based on the anthropometric needs of the patients, with a caloric reduction (-500 kcal). These weekly menus (Sunday to Monday) consist of 5 meal times (breakfast, snack, lunch, snack and dinner). The distribution of the macronutrients: carbohydrates, proteins and fats, as well as the percentages of polyunsaturated, monounsaturated and saturated fatty acids, will be in accordance with the recommendations made by the WHO (World Health Organization), the AHA (American Heart Association) and the NOM (Official Mexican Standards) for the treatment of obesity and dyslipidemias
The 3 face-to-face evaluations (baseline, 1st month, final) will include anthropometric and biochemical evaluations. Therefore, the following criteria will be measured:
Weight (kg) Height (cm) BMI(kg/m2) Waist circumference and hip circumference (cm) Blood pressure Body composition determination
Blood will be obtained from the antecubital vein, it will be centrifuged to obtain the serum and later it will determine:
Glucose (mg / dL) Total cholesterol (mg / dL) Triglycerides (mg / dL) HDL-c (mg / dL) LDL-c (mg / dL) VLDL-c (mg / dL) Insulin (microIU/mL) C-reactive protein (mg/L) Interleukins, among other parameters
Every 15 days there will be virtual remote consultations, through the zoom platform. In these sessions, the nutritional clinical history and various medical and dietary questionnaires will be applied to evaluate secondary results. In addition, a new food plan will be delivered, according to the needs of the participant and taking into account the characteristics of the experimental treatment to which they belong.
This research will be conducted at The Institute of Translational Nutrigenetics and Nutrigenomics, Department of Molecular Biology and Genomics, Health Sciences University Center, University of Guadalajara, Guadalajara, Mexico
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled clinical trial, parallel, with 2 study groups
| Arm | Type | Receives |
|---|---|---|
| Nutrigenetic Diet Group | Experimental | Other: NUTRIGENETIC DIET INTERVENTIONParticipants randomly included in this group will receive nutrigenetic menus, i.e., considering the genotypes of the 11 variants analyzed. |
| Conventional Diet Group | Experimental | Other: CONVENTIONAL DIET INTERVENTIONParticipants randomly included in this group will receive menus prepared following the international conventional guidelines set out by the WHO, AHA and Official Mexican Standards (NOM) for the treatment of obesity and dyslipidemia. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Men and women
- 18-50 years old
- Mexican- Mexican ancestry (3 generations)
- Live in Guadalajara, Jalisco or metropolitan area.
- Being overweight or obese BMI 25> 40
Key exclusion criteria (10 listed)
- Not meeting the inclusion criteria.
- Pregnancy or breastfeeding
- Gastrointestinal disorders
- Endocrinopathies
- Cardiovascular events
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 |
|---|---|---|
| NUTRIGENETIC DIET INTERVENTIONAlso: Nutrigenetic diet groupWeekly, personalized meal plans (menus) will be provided, prepared based on the anthropometric needs of the patients, with a caloric reduction (-500 kcal). These weekly menus (Sunday to Monday) consist of 5 meal times (breakfast, snack, lunch, snack and dinner). The distribution of the macronutrients: carbohydrates, proteins and fats, as well as the percentages of polyunsaturated, monounsaturated and saturated fatty acids, will be established according to certain nutrigenetic recommendations identified in the reference bibliography. Participants included in this group will receive remote (virtual) nutritional counseling every 15 days. | Other | Nutrigenetic Diet Group |
| CONVENTIONAL DIET INTERVENTIONAlso: Conventional diet groupWeekly, personalized meal plans (menus) will be provided, prepared based on the anthropometric needs of the patients, with a caloric reduction (-500 kcal). These weekly menus (Sunday to Monday) consist of 5 meal times (breakfast, snack, lunch, snack and dinner). The distribution of the macronutrients: carbohydrates, proteins and fats, as well as the percentages of polyunsaturated, monounsaturated and saturated fatty acids, will be in accordance with the recommendations made by the WHO (World Health Organization), the AHA (American heart association) and the NOM (Official Mexican Standards) for the treatment of obesity and dyslipidemias. Participants included in this group will receive remote (virtual) nutritional counseling every 15 days. | Other | Conventional Diet Group |
Primary outcome
Lipid profile change
Time frame: Baseline, week 4, week 8
Measurements of total cholesterol, LDL cholesterol, VLDL cholesterol, HDL cholesterol, and triglycerides will be evaluated to assess lipid profile change.
15 secondary outcomes
Body composition change
Time frame: Baseline, week 4, week 8
Visceral fat index change
Time frame: Baseline, week 4, week 8
Body Weight change
Time frame: Baseline, week 4, week 8
Anthropometric measurements change
Time frame: Baseline, week 4, week 8
Body Mass Index (BMI) change
Time frame: Baseline, week 4, week 8
tumor Necrosis factor- alfa (TNF-alfa)
Time frame: Baseline, week 4, week 8
C-reactive protein (CRP)
Time frame: Baseline, week 4, week 8
Interleukins levels
Time frame: Baseline, week 4, week 8
Change in glucose
Time frame: Baseline, week 4, week 8
Change in blood pressure
Time frame: Baseline, week 4, week 8
Adherence to nutritional intervention
Time frame: Week 4, week 8
Change in food intake
Time frame: Baseline, Week 4, week 8
Change in physical activity practice
Time frame: Baseline, week 8
Change in insulin level
Time frame: Baseline, week 4, week 8
Insulin Resistance (HOMA-IR)
Time frame: Baseline, week 4, week 8
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 27 Jan 2022.
- Background: PubMed 32714508Barrea L, Annunziata G, Bordoni L, Muscogiuri G, Colao A, Savastano S; Obesity Programs of nutrition, Education, Research and Assessment (OPERA) Group. Nutrigenetics-personalized nutrition in obesity and cardiovascular diseases. Int J Obes Suppl. 2020 Jul;10(1):1-13. doi: 10.1038/s41367-020-0014-4. Epub 2020 Jul 20.
- Background: PubMed 22591901Corella D, Ordovas JM. Interactions between dietary n-3 fatty acids and genetic variants and risk of disease. Br J Nutr. 2012 Jun;107 Suppl 2(0 2):S271-83. doi: 10.1017/S0007114512001651.
- Background: PubMed 30467071de Luis D, Izaola O, Primo D, Aller R. Role of rs670 variant of APOA1 gene on metabolic response after a high fat vs. a low fat hypocaloric diets in obese human subjects. J Diabetes Complications. 2019 Mar;33(3):249-254. doi: 10.1016/j.jdiacomp.2018.10.015. Epub 2018 Nov 3.
- Background: PubMed 28214526Fall T, Mendelson M, Speliotes EK. Recent Advances in Human Genetics and Epigenetics of Adiposity: Pathway to Precision Medicine? Gastroenterology. 2017 May;152(7):1695-1706. doi: 10.1053/j.gastro.2017.01.054. Epub 2017 Feb 15.
- Background: PubMed 30279335Hannon BA, Khan NA, Teran-Garcia M. Nutrigenetic Contributions to Dyslipidemia: A Focus on Physiologically Relevant Pathways of Lipid and Lipoprotein Metabolism. Nutrients. 2018 Oct 2;10(10):1404. doi: 10.3390/nu10101404.
- Background: PubMed 21209257Sanchez-Moreno C, Ordovas JM, Smith CE, Baraza JC, Lee YC, Garaulet M. APOA5 gene variation interacts with dietary fat intake to modulate obesity and circulating triglycerides in a Mediterranean population. J Nutr. 2011 Mar;141(3):380-5. doi: 10.3945/jn.110.130344. Epub 2011 Jan 5.
- Background: PubMed 25926410Xu M, Ng SS, Bray GA, Ryan DH, Sacks FM, Ning G, Qi L. Dietary Fat Intake Modifies the Effect of a Common Variant in the LIPC Gene on Changes in Serum Lipid Concentrations during a Long-Term Weight-Loss Intervention Trial. J Nutr. 2015 Jun;145(6):1289-94. doi: 10.3945/jn.115.212514. Epub 2015 Apr 29.
- Background: PubMed 22914552Zhang X, Qi Q, Bray GA, Hu FB, Sacks FM, Qi L. APOA5 genotype modulates 2-y changes in lipid profile in response to weight-loss diet intervention: the Pounds Lost Trial. Am J Clin Nutr. 2012 Oct;96(4):917-22. doi: 10.3945/ajcn.112.040907. Epub 2012 Aug 22.
- Results publication: PubMed 21949049AlSaleh A, O'Dell SD, Frost GS, Griffin BA, Lovegrove JA, Jebb SA, Sanders TAB. Interaction of PPARG Pro12Ala with dietary fat influences plasma lipids in subjects at cardiometabolic risk. J Lipid Res. 2011 Dec;52(12):2298-2303. doi: 10.1194/jlr.P019281. Epub 2011 Sep 23.
- Individual participant dataSharing planned: No. All information provided by participant is strictly confidential, will be used only by the project's research team and will not be available for any other purpose. The results obtained from this study will be published for scientific purposes but the confidentiality of the participants will never be violated. The information or evidence obtained will be eliminated after fulfilling the scientific purposes for which this intervention was proposed.
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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.
Edgar J Mendivil, PhD study director
Instituto Tecnológico y de Estudios Superiores de Occidente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NUTRIGENETIC DIET INTERVENTION and CONVENTIONAL DIET INTERVENTION in people with Dyslipidemias and Overweight and Obesity, run by Instituto Tecnológico y de Estudios Superiores de Occidente at 1 site in Mexico.
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 8 inclusion and 10 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 27 Jan 2022. 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 Mexico. 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?
Lipid profile change (time frame: Baseline, week 4, week 8). 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 NCT05210023, which also lists 9 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 27 Jan 2022.