Development of a Nutrigenetic Test for Personalized Prescription of Body Weight Loss Diets (Obekit)

NCT02737267 | Unknown DMC

• 1 other identifier: 132/2015
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the relationship between several genetic variants and the response to a hypocaloric diet, in order to design a genetic test which permits prescribe the more personalized diet for each individual according to her genotype. Half of the participants will assigned to a moderate high protein diet, while the other half will assigned to a high carbohydrate diet.

Conditions

Body Weight Changes

Keywords

Genetics; Polymorphism; Epigenetics; Metagenomics; Metabolomics; Metabolic syndrome conditions; Precision nutrition

Outcome Measures

Primary Outcomes (2)

• Change in body weight at Week 16

  Baseline and 16 Weeks

• Change in body weight at Week 40

  16 Weeks and 40 Weeks

Secondary Outcomes (92)

• Height

  Baseline

• Change in waist and hip circumferences at 16 Weeks

  Baseline and 16 Weeks

• Change in waist and hip circumferences at 40 Weeks

  16 Weeks and 40 Weeks

• Change in body fat mass at 16 Weeks

  Baseline and 16 Weeks

• Change in body fat mass at 40 Weeks

  16 Weeks and 40 Weeks

Study Arms (2)

Moderately high protein diet

EXPERIMENTAL

Caloric restriction (-30% total energy intake) Macronutrient distribution: 40% of the energy derived from carbohydrates, 30% of the energy derived from protein and 30% of the energy derived from fat

Behavioral: Moderately high protein diet

Low fat diet

PLACEBO COMPARATOR

Caloric restriction (-30% total energy intake) Macronutrient distribution: 60% of the energy derived from carbohydrates, 18% of the energy derived from protein and 22% of the energy derived from fat

Behavioral: Low fat diet

Interventions

Moderately high protein diet BEHAVIORAL

After the recruitment randomization of the study participants, the study will consists of a 4-month nutritional intervention ("body weight loss period") followed by a second 6-month period ("body weight maintenance period") in which the subjects of the study will continue with the assigned diet, but without any energy restriction.

Moderately high protein diet

Low fat diet BEHAVIORAL

After the recruitment randomization of the study participants, the study will consists of a 4-month nutritional intervention ("body weight loss period") followed by a second 6-month period ("body weight maintenance period") in which the subjects of the study will continue with the assigned diet, but without any energy restriction.the energy derived from fat

Low fat diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body Mass Index (BMI) between 25 and 40 kg/m2
• Physical examination and vital signs normal, or is considered abnormal, but clinically insignificant by researcher.

You may not qualify if:

• BMI less than 25 or higher than 40 kg/m2
• Pregnant women
• Breastfeeding period. If artificial feeding until 6 months after birth.
• Type 1 diabetes
• Severe kidney diseases
• Severe digestive system diseases
• Electrolyte disorders (disorders of sodium, potassium, calcium, chlorine, phosphorus, magnesium)
• Acute cardiovascular diseases
• Cancer
• Anemia
• Eating disorders
• Recent prescription drug treatment (without stable doses scheduled)
• Drug therapy that can influence weight loss as corticosteroids.
• Some type of cognitive impairment and / psychic
• Subjects in which poor collaboration or, in the investigator's opinion, have difficulty following the procedures of the study is foreseen

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

Centre for Nutrition Research, University of Navarra

Pamplona, Navarre, 31008, Spain

Location

Related Publications (5)

• Garcia-Alvarez NC, Riezu-Boj JI, Martinez JA, Garcia-Calzon S, Milagro FI. A Predictive Tool Based on DNA Methylation Data for Personalized Weight Loss through Different Dietary Strategies: A Pilot Study. Nutrients. 2023 Dec 6;15(24):5023. doi: 10.3390/nu15245023.

  PMID: 38140282 DERIVED

• Cuevas-Sierra A, Milagro FI, Guruceaga E, Cuervo M, Goni L, Garcia-Granero M, Martinez JA, Riezu-Boj JI. A weight-loss model based on baseline microbiota and genetic scores for selection of dietary treatments in overweight and obese population. Clin Nutr. 2022 Aug;41(8):1712-1723. doi: 10.1016/j.clnu.2022.06.008. Epub 2022 Jun 16.

  PMID: 35777110 DERIVED

• Cuevas-Sierra A, Romo-Hualde A, Aranaz P, Goni L, Cuervo M, Martinez JA, Milagro FI, Riezu-Boj JI. Diet- and sex-related changes of gut microbiota composition and functional profiles after 4 months of weight loss intervention. Eur J Nutr. 2021 Sep;60(6):3279-3301. doi: 10.1007/s00394-021-02508-0. Epub 2021 Feb 16.

  PMID: 33591390 DERIVED

• Ramos-Lopez O, Cuervo M, Goni L, Milagro FI, Riezu-Boj JI, Martinez JA. Modeling of an integrative prototype based on genetic, phenotypic, and environmental information for personalized prescription of energy-restricted diets in overweight/obese subjects. Am J Clin Nutr. 2020 Feb 1;111(2):459-470. doi: 10.1093/ajcn/nqz286.

  PMID: 31751449 DERIVED

• Ramos-Lopez O, Riezu-Boj JI, Milagro FI, Goni L, Cuervo M, Martinez JA. Differential lipid metabolism outcomes associated with ADRB2 gene polymorphisms in response to two dietary interventions in overweight/obese subjects. Nutr Metab Cardiovasc Dis. 2018 Feb;28(2):165-172. doi: 10.1016/j.numecd.2017.11.006. Epub 2017 Dec 5.

  PMID: 29331538 DERIVED

MeSH Terms

Conditions

Body Weight Changes

Interventions

Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• J. Alfredo Martínez, MD, PhD

  Centre for Nutrition Research, University of Navarra. CIBER Obesity and Physiopathology of Nutrition (CIBERobn), Institute of Health Carlos III Madrid Spain

  PRINCIPAL INVESTIGATOR

• Fernando J. Corrales, PhD

  CIMA, University of Navarra

  PRINCIPAL INVESTIGATOR

• Femín I Milagro, PhD

  Centre for Nutrition Research, University of Navarra. CIBER Obesity and Physiopathology of Nutrition (CIBERobn), Institute of Health Carlos III Madrid Spain

  STUDY CHAIR

• Jose Ignacio Riezu, PhD

  Centre for Nutrition Research, University of Navarra

  STUDY CHAIR

• Carlos González-Navarro, PhD

  Centre for Nutrition Research, University of Navarra

  STUDY CHAIR

• Marta Cuervo, PhD

  Centre for Nutrition Research, University of Navarra

  STUDY CHAIR

• Iosune Zubieta

  Centre for Nutrition Research, University of Navarra

  STUDY CHAIR

• Blanca Esther Martínez de Morentin, MD

  Centre for Nutrition Research, University of Navarra

  STUDY CHAIR

• Leticia Goñi

  Centre for Nutrition Research, University of Navarra

  STUDY CHAIR

• Santiago Navas, PhD

  Centre for Nutrition Research, University of Navarra. CIBER Obesity and Physiopathology of Nutrition (CIBERobn), Institute of Health Carlos III Madrid Spain

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: April 13, 2016
• Study Start: November 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 29, 2017

Record last verified: 2015-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)