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A study protocol for a pilot randomized controlled trial to evaluate the effectiveness of a gene-based nutrition and lifestyle recommendation for weight management among adults: the MyGeneMyDiet(®) study
INTRODUCTION: Managing nutrition and lifestyle practices, nutrition phenotypes, and the genome forms the foundation of precision nutrition. Precision nutrition focuses on metabolic variability among individuals, and one approach to achieving its goals is to integrate gene-based nutrition and lifesty...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10477364/ https://www.ncbi.nlm.nih.gov/pubmed/37674889 http://dx.doi.org/10.3389/fnut.2023.1238234 |
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author | Nacis, Jacus S. Labrador, Jason Paolo H. Ronquillo, Diana Glades D. Rodriguez, Marietta P. Dablo, Aurora Maria Francesca D. Frane, Ruby D. Madrid, Marilou L. Santos, Noelle Lyn C. Carrillo, Julianne Janine V. Fernandez, Mikko Glen Gonzales, Gerard Bryan L. |
author_facet | Nacis, Jacus S. Labrador, Jason Paolo H. Ronquillo, Diana Glades D. Rodriguez, Marietta P. Dablo, Aurora Maria Francesca D. Frane, Ruby D. Madrid, Marilou L. Santos, Noelle Lyn C. Carrillo, Julianne Janine V. Fernandez, Mikko Glen Gonzales, Gerard Bryan L. |
author_sort | Nacis, Jacus S. |
collection | PubMed |
description | INTRODUCTION: Managing nutrition and lifestyle practices, nutrition phenotypes, and the genome forms the foundation of precision nutrition. Precision nutrition focuses on metabolic variability among individuals, and one approach to achieving its goals is to integrate gene-based nutrition and lifestyle recommendations in nutrition practice. However, scientific evidence proving the effectiveness of such recommendations is limited. This study will examine whether providing nutrition and lifestyle recommendations based on individual genotype can lead to better weight loss, along with reduction in body mass index (BMI), waist circumference, and body fat percentage among overweight and obese adults. METHODS AND ANALYSIS: A parallel group, single-blind, randomized controlled trial will be conducted. Sixty-two overweight/obese individuals aged 19–59 years old will be recruited. Participants will be randomly allocated to either the intervention (n = 31) or the control arm (n = 31). Participants in the intervention group will receive the MyGeneMyDiet(®) Recommendation for Weight Management, a gene-based nutrition and lifestyle recommendation that was developed based on existing evidence of the effects of FTO rs9939609 on body weight, BMI, and physical activity; UCP1 rs1800592 on calorie intake; and TCF7L2 rs7903146 on dietary fat intake. Participants in the control group will receive the standard recommendations for weight management. The primary outcomes will be the differences in weight, BMI, waist circumference, and body fat percentage between arms in both the active phase (6 months) and inactive phase (last 6 months) of the trial. Participants in both arms will be evaluated at baseline and in months 3, 6, 9, and 12. DISCUSSION: To the best of our knowledge, this will be the first gene-based intervention that will adopt a phase of intensive nutrition counseling, followed by a simulation of a free-living state to determine adherence to a gene-based recommendation. This study will contribute to the future implementation of precision nutrition interventions by providing evidence on the effectiveness of a gene-based nutrition and lifestyle recommendation for weight loss. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov, identifier [NCT05098899]. |
format | Online Article Text |
id | pubmed-10477364 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-104773642023-09-06 A study protocol for a pilot randomized controlled trial to evaluate the effectiveness of a gene-based nutrition and lifestyle recommendation for weight management among adults: the MyGeneMyDiet(®) study Nacis, Jacus S. Labrador, Jason Paolo H. Ronquillo, Diana Glades D. Rodriguez, Marietta P. Dablo, Aurora Maria Francesca D. Frane, Ruby D. Madrid, Marilou L. Santos, Noelle Lyn C. Carrillo, Julianne Janine V. Fernandez, Mikko Glen Gonzales, Gerard Bryan L. Front Nutr Nutrition INTRODUCTION: Managing nutrition and lifestyle practices, nutrition phenotypes, and the genome forms the foundation of precision nutrition. Precision nutrition focuses on metabolic variability among individuals, and one approach to achieving its goals is to integrate gene-based nutrition and lifestyle recommendations in nutrition practice. However, scientific evidence proving the effectiveness of such recommendations is limited. This study will examine whether providing nutrition and lifestyle recommendations based on individual genotype can lead to better weight loss, along with reduction in body mass index (BMI), waist circumference, and body fat percentage among overweight and obese adults. METHODS AND ANALYSIS: A parallel group, single-blind, randomized controlled trial will be conducted. Sixty-two overweight/obese individuals aged 19–59 years old will be recruited. Participants will be randomly allocated to either the intervention (n = 31) or the control arm (n = 31). Participants in the intervention group will receive the MyGeneMyDiet(®) Recommendation for Weight Management, a gene-based nutrition and lifestyle recommendation that was developed based on existing evidence of the effects of FTO rs9939609 on body weight, BMI, and physical activity; UCP1 rs1800592 on calorie intake; and TCF7L2 rs7903146 on dietary fat intake. Participants in the control group will receive the standard recommendations for weight management. The primary outcomes will be the differences in weight, BMI, waist circumference, and body fat percentage between arms in both the active phase (6 months) and inactive phase (last 6 months) of the trial. Participants in both arms will be evaluated at baseline and in months 3, 6, 9, and 12. DISCUSSION: To the best of our knowledge, this will be the first gene-based intervention that will adopt a phase of intensive nutrition counseling, followed by a simulation of a free-living state to determine adherence to a gene-based recommendation. This study will contribute to the future implementation of precision nutrition interventions by providing evidence on the effectiveness of a gene-based nutrition and lifestyle recommendation for weight loss. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov, identifier [NCT05098899]. Frontiers Media S.A. 2023-08-22 /pmc/articles/PMC10477364/ /pubmed/37674889 http://dx.doi.org/10.3389/fnut.2023.1238234 Text en Copyright © 2023 Nacis, Labrador, Ronquillo, Rodriguez, Dablo, Frane, Madrid, Santos, Carrillo, Fernandez and Gonzales. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Nutrition Nacis, Jacus S. Labrador, Jason Paolo H. Ronquillo, Diana Glades D. Rodriguez, Marietta P. Dablo, Aurora Maria Francesca D. Frane, Ruby D. Madrid, Marilou L. Santos, Noelle Lyn C. Carrillo, Julianne Janine V. Fernandez, Mikko Glen Gonzales, Gerard Bryan L. A study protocol for a pilot randomized controlled trial to evaluate the effectiveness of a gene-based nutrition and lifestyle recommendation for weight management among adults: the MyGeneMyDiet(®) study |
title | A study protocol for a pilot randomized controlled trial to evaluate the effectiveness of a gene-based nutrition and lifestyle recommendation for weight management among adults: the MyGeneMyDiet(®) study |
title_full | A study protocol for a pilot randomized controlled trial to evaluate the effectiveness of a gene-based nutrition and lifestyle recommendation for weight management among adults: the MyGeneMyDiet(®) study |
title_fullStr | A study protocol for a pilot randomized controlled trial to evaluate the effectiveness of a gene-based nutrition and lifestyle recommendation for weight management among adults: the MyGeneMyDiet(®) study |
title_full_unstemmed | A study protocol for a pilot randomized controlled trial to evaluate the effectiveness of a gene-based nutrition and lifestyle recommendation for weight management among adults: the MyGeneMyDiet(®) study |
title_short | A study protocol for a pilot randomized controlled trial to evaluate the effectiveness of a gene-based nutrition and lifestyle recommendation for weight management among adults: the MyGeneMyDiet(®) study |
title_sort | study protocol for a pilot randomized controlled trial to evaluate the effectiveness of a gene-based nutrition and lifestyle recommendation for weight management among adults: the mygenemydiet(®) study |
topic | Nutrition |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10477364/ https://www.ncbi.nlm.nih.gov/pubmed/37674889 http://dx.doi.org/10.3389/fnut.2023.1238234 |
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