Nutrigenetic Intervention on Blood Lipid Markers and Body Composition of Adults With Overweight and Obesity

NCT05210023 | Completed

• 1 other identifier: NUTRIGENETIC_INTERV07
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyslipidemias; Overweight and Obesity

Keywords

nutrigenetic; polymorphisms; dietetic intervention; lipid levels

Outcome Measures

Primary Outcomes (1)

• Lipid profile change

  Measurements of total cholesterol, LDL cholesterol, VLDL cholesterol, HDL cholesterol, and triglycerides will be evaluated to assess lipid profile change.

  Baseline, week 4, week 8

Secondary Outcomes (15)

• Body composition change

  Baseline, week 4, week 8

• Visceral fat index change

  Baseline, week 4, week 8

• Body Weight change

  Baseline, week 4, week 8

• Anthropometric measurements change

  Baseline, week 4, week 8

• Body Mass Index (BMI) change

  Baseline, week 4, week 8

Study Arms (2)

Nutrigenetic Diet Group

EXPERIMENTAL

Participants randomly included in this group will receive nutrigenetic menus, i.e., considering the genotypes of the 11 variants analyzed.

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.

Other: CONVENTIONAL DIET INTERVENTION

Interventions

NUTRIGENETIC DIET INTERVENTION OTHER

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.

Also known as: Nutrigenetic diet group

Nutrigenetic Diet Group

CONVENTIONAL DIET INTERVENTION OTHER

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.

Also known as: Conventional diet group

Conventional Diet Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women
• 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

You may not qualify if:

• Pregnancy or breastfeeding
• Gastrointestinal disorders
• Endocrinopathies
• Cardiovascular events
• Diagnosed psychiatric illnesses.
• Diagnosed diabetes
• Take lipid-lowering drugs
• Autoimmune diseases.
• Covid +

Sponsors & Collaborators

• Instituto Tecnológico y de Estudios Superiores de Occidente: lead
• Instituto Tecnológico de Tepic: collaborator
• University of Guadalajara: collaborator

Study Sites (1)

Institute of Translational Nutrigenetics and Nutrigenomics, Department of Molecular Biology and Genomics, Health Sciences University Center, University of Guadalajara,

Guadalajara, Jalisco, 44340, Mexico

Location

Related Publications (9)

• 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.

  PMID: 32714508 BACKGROUND

• 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.

  PMID: 22591901 BACKGROUND

• de 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.

  PMID: 30467071 BACKGROUND

• 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.

  PMID: 28214526 BACKGROUND

• 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.

  PMID: 30279335 BACKGROUND

• 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.

  PMID: 21209257 BACKGROUND

• 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.

  PMID: 25926410 BACKGROUND

• Zhang 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.

  PMID: 22914552 BACKGROUND

• AlSaleh 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.

  PMID: 21949049 RESULT

MeSH Terms

Conditions

Dyslipidemias; Overweight; Obesity

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Edgar J Mendivil, PhD

  Instituto Tecnológico y de Estudios Superiores de Occidente

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled clinical trial, parallel, with 2 study groups

Study Record Dates

• First Submitted: December 31, 2021
• First Posted: January 27, 2022
• Study Start: June 9, 2021
• Primary Completion: December 22, 2021
• Study Completion: December 22, 2021
• Last Updated: January 27, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)