Nutrigenetic Intervention on Blood Lipid Markers and Body Composition of Adults With Overweight and Obesity
Primary Purpose
Dyslipidemias, Overweight and Obesity
Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
NUTRIGENETIC DIET INTERVENTION
CONVENTIONAL DIET INTERVENTION
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemias focused on measuring nutrigenetic, polymorphisms, dietetic intervention, lipid levels
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Not meeting the inclusion criteria.
- Pregnancy or breastfeeding
- Gastrointestinal disorders
- Endocrinopathies
- Cardiovascular events
- Diagnosed psychiatric illnesses.
- Diagnosed diabetes
- Take lipid-lowering drugs
- Autoimmune diseases.
- Covid +
Sites / Locations
- Institute of Translational Nutrigenetics and Nutrigenomics, Department of Molecular Biology and Genomics, Health Sciences University Center, University of Guadalajara,
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Nutrigenetic Diet Group
Conventional Diet Group
Arm Description
Participants randomly included in this group will receive nutrigenetic menus, i.e., considering the genotypes of the 11 variants analyzed.
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.
Outcomes
Primary Outcome Measures
Lipid profile change
Measurements of total cholesterol, LDL cholesterol, VLDL cholesterol, HDL cholesterol, and triglycerides will be evaluated to assess lipid profile change.
Secondary Outcome Measures
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)
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)
Body Weight change
Measurement of body weight (kg) will be evaluated to assess anthropometric change.
Anthropometric measurements change
Waist circumference (cm) and hip circumference (cm) will be evaluated to assess anthropometric change.
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)
tumor Necrosis factor- alfa (TNF-alfa)
Change in TNF-alfa (pg/ml) will be evaluated as a marker of inflammation
C-reactive protein (CRP)
Change in C-reactive protein (CRP)( mg/L) will be evaluated as a marker of inflammation
Interleukins levels
Determination of serum levels of Interleukin (IL) 6, IL1, IL10 (pg/ml) will be evaluated as a markers of inflammation
Change in glucose
Measuring glucose levels will determine changes in this parameter
Change in blood pressure
Systolic and diastolic pressure measurement will determine changes in blood pressure
Adherence to nutritional intervention
It will be evaluated through changes in food consumption (food frequency questionnaire)
Change in food intake
Change in food intake using Food Frequency Questionnaire
Change in physical activity practice
Change in physical activity practice using International Physical Activity Questionnaire - Short Form
Change in insulin level
Measurement of insulin levels will determine changes in this parameter (microIU/ml)
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
Full Information
NCT ID
NCT05210023
First Posted
December 31, 2021
Last Updated
January 13, 2022
Sponsor
Instituto Tecnológico y de Estudios Superiores de Occidente
Collaborators
Instituto Tecnológico de Tepic, University of Guadalajara
1. Study Identification
Unique Protocol Identification Number
NCT05210023
Brief Title
Nutrigenetic Intervention on Blood Lipid Markers and Body Composition of Adults With Overweight and Obesity
Official Title
Effect of a Nutrigenetic Intervention on Blood Lipid Markers and Body Composition of Adults With Overweight and Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
June 9, 2021 (Actual)
Primary Completion Date
December 22, 2021 (Actual)
Study Completion Date
December 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Tecnológico y de Estudios Superiores de Occidente
Collaborators
Instituto Tecnológico de Tepic, University of Guadalajara
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias, Overweight and Obesity
Keywords
nutrigenetic, polymorphisms, dietetic intervention, lipid levels
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled clinical trial, parallel, with 2 study groups
Masking
Participant
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutrigenetic Diet Group
Arm Type
Experimental
Arm Description
Participants randomly included in this group will receive nutrigenetic menus, i.e., considering the genotypes of the 11 variants analyzed.
Arm Title
Conventional Diet Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
NUTRIGENETIC DIET INTERVENTION
Other Intervention Name(s)
Nutrigenetic diet group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
CONVENTIONAL DIET INTERVENTION
Other Intervention Name(s)
Conventional diet group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lipid profile change
Description
Measurements of total cholesterol, LDL cholesterol, VLDL cholesterol, HDL cholesterol, and triglycerides will be evaluated to assess lipid profile change.
Time Frame
Baseline, week 4, week 8
Secondary Outcome Measure Information:
Title
Body composition change
Description
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)
Time Frame
Baseline, week 4, week 8
Title
Visceral fat index change
Description
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)
Time Frame
Baseline, week 4, week 8
Title
Body Weight change
Description
Measurement of body weight (kg) will be evaluated to assess anthropometric change.
Time Frame
Baseline, week 4, week 8
Title
Anthropometric measurements change
Description
Waist circumference (cm) and hip circumference (cm) will be evaluated to assess anthropometric change.
Time Frame
Baseline, week 4, week 8
Title
Body Mass Index (BMI) change
Description
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)
Time Frame
Baseline, week 4, week 8
Title
tumor Necrosis factor- alfa (TNF-alfa)
Description
Change in TNF-alfa (pg/ml) will be evaluated as a marker of inflammation
Time Frame
Baseline, week 4, week 8
Title
C-reactive protein (CRP)
Description
Change in C-reactive protein (CRP)( mg/L) will be evaluated as a marker of inflammation
Time Frame
Baseline, week 4, week 8
Title
Interleukins levels
Description
Determination of serum levels of Interleukin (IL) 6, IL1, IL10 (pg/ml) will be evaluated as a markers of inflammation
Time Frame
Baseline, week 4, week 8
Title
Change in glucose
Description
Measuring glucose levels will determine changes in this parameter
Time Frame
Baseline, week 4, week 8
Title
Change in blood pressure
Description
Systolic and diastolic pressure measurement will determine changes in blood pressure
Time Frame
Baseline, week 4, week 8
Title
Adherence to nutritional intervention
Description
It will be evaluated through changes in food consumption (food frequency questionnaire)
Time Frame
Week 4, week 8
Title
Change in food intake
Description
Change in food intake using Food Frequency Questionnaire
Time Frame
Baseline, Week 4, week 8
Title
Change in physical activity practice
Description
Change in physical activity practice using International Physical Activity Questionnaire - Short Form
Time Frame
Baseline, week 8
Title
Change in insulin level
Description
Measurement of insulin levels will determine changes in this parameter (microIU/ml)
Time Frame
Baseline, week 4, week 8
Title
Insulin Resistance (HOMA-IR)
Description
Insulin resistance will be determined using HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) fasting serum glucose (mg/dL) x insulin (mIU /L) / 405
Time Frame
Baseline, week 4, week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Not meeting the inclusion criteria.
Pregnancy or breastfeeding
Gastrointestinal disorders
Endocrinopathies
Cardiovascular events
Diagnosed psychiatric illnesses.
Diagnosed diabetes
Take lipid-lowering drugs
Autoimmune diseases.
Covid +
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edgar J Mendivil, PhD
Organizational Affiliation
Instituto Tecnológico y de Estudios Superiores de Occidente
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Translational Nutrigenetics and Nutrigenomics, Department of Molecular Biology and Genomics, Health Sciences University Center, University of Guadalajara,
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
32714508
Citation
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Results Reference
background
PubMed Identifier
22591901
Citation
Corella 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.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
Fall 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.
Results Reference
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PubMed Identifier
30279335
Citation
Hannon 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.
Results Reference
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PubMed Identifier
21209257
Citation
Sanchez-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.
Results Reference
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PubMed Identifier
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Citation
Xu 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.
Results Reference
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Citation
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Results Reference
result
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Nutrigenetic Intervention on Blood Lipid Markers and Body Composition of Adults With Overweight and Obesity
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