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Gene-Environment Interaction and Precision Nutrition on Adiposity, Glycemic, Lipids Changes, and Bone Health

26 août 2019 mis à jour par: Lu Qi, Tulane University

Obesity Genes, Energy Regulation in Response to Weight-Loss

The purpose of this study is to test the interactions between the genes and diet interventions varying in macronutrient intake on glycemic, waist circumference, body weight, visceral fat and lipids changes. In the POUNDS LOST, all of the 811 participants DNA was extracted from the buffy coat fraction of centrifuged blood using the QIAmp blood kit (Qiagen, Chatsworth, CA). Single nucleotide polymorphisms were genotyped using the OpenArray™ SNP genotyping system (BioTrove, Woburn, MA). The study is only accepting participants in the Boston, Massachusetts or Baton Rouge, Louisiana area. For further enrollment information in Boston or Baton Rouge, see Eligibility Criteria or Design Narrative.

Besides, the investigators integrated novel pathway analyses in large cohorts and comprehensive genetic analyses on long-term weight loss and mechanisms in randomized diet intervention trials would provide very important evidence to unravel the etiology of obesity, and have significant public health and clinical implications. Establishing relationship between genetic variants and diets in determining weight change will help identify individuals at high risk for obesity especially when adherent to specific diet.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

The epidemic of obesity has become a major public health problem. Obesity is a multifactorial abnormality that has a genetic basis but requires environmental influences to manifest. Common-form obesity is underpinned by both environmental and genetic factors. Recent genome-wide association studies have identified several genes convincingly related to obesity risk. Testing gene-environment interaction is a relatively new field. Evidence from association studies and intervention trials continues to mount, indicating that genetic components may modify lifestyle effects on the development of obesity. However, these findings are at most preliminary. The interplay between genetic and environmental components may facilitate the choice of more effective and specific measures for obesity prevention based on personalized genetic make-up.

The investigators aimed to examine whether the genetic variation affected glycemic, waist circumference, body weight, visceral fat and lipids changes in response to weight-loss dietary intervention varying in macronutrient intake (target percentages of energy derived from fat, protein, and carbohydrate in the 4 diets were as follows 20%, 15% and 65%; 20%, 25%, and 55%; 40%, 15%, and 45%; and 40%, 25%, and 35%).

The primary outcome is to test the interactions between the genes and diet interventions varying in macronutrient intake on body weight changes. The secondary outcome is to test the interactions between the genes and diet interventions varying in macronutrient intake on glycemic, waist circumference, visceral fat, and lipids changes. Understanding gene-diet interactions in relation to weight loss hold great promise for delivering more efficient prevention and treatment on obesity and related metabolic disorders.

In addition, besides gene-diet interactions, the investigators will also conduct other precision nutrition analysis. These analyses include interactions between pretreatment factors with diet intervention adiposity traits, initial changes induced by diet intervention with various outcomes measured in POUNDS Lost, including body weight, waist circumference, body composition, ectopic fat, and bone health.

Type d'étude

Interventionnel

Inscription (Réel)

811

Phase

  • N'est pas applicable

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

30 ans à 70 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Only accepting participants in the Boston, Massachusetts or Baton Rouge, Louisiana area
  • Between the ages of 30 - 70
  • Willing to modify eating pattern according to instructions
  • Overweight or obese and in good health with a BMI of 25-40
  • Committed to a long-term weight loss and maintenance program
  • Willing to attend multiple weight loss group sessions
  • Willing to increase activity level

Exclusion Criteria:

  • Pregnant, planning to become pregnant, or are breastfeeding
  • Unwilling to participate in the schedule of group sessions and individual visits
  • Unstable or recent onset of heart disease or any other serious illness
  • Cannot change diet due to medical or other reasons
  • Planning to leave the area prior to the anticipated end of participation
  • Current participation in another clinical trial with an intervention that affects weight change
  • Have diabetes that is treated with insulin or hypoglycemic oral medicines
  • Diagnosis of psychiatric or emotional problems within 6 months of study
  • Currently have an eating disorder
  • Have hypothyroidism
  • Have an unstable weight

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation factorielle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: diet 1
diet with moderate in fat (40% energy) and protein(15%)
Autre: Preventing Overweight Using Novel Dietary Strategies
The study tests the effectiveness for weight loss and weight maintenance of four diets differing in macronutrient composition: moderate in fat (40% energy) with two different protein levels (15% and 25%), and low in fat (20% energy), also with 15% and 25% protein levels.
Expérimental: diet 2
diet with moderate in fat (40% energy) and protein(25%)
Autre: Preventing Overweight Using Novel Dietary Strategies
The study tests the effectiveness for weight loss and weight maintenance of four diets differing in macronutrient composition: moderate in fat (40% energy) with two different protein levels (15% and 25%), and low in fat (20% energy), also with 15% and 25% protein levels.
Expérimental: diet 3
diet with low in fat (20% energy) and protein(15%)
Autre: Preventing Overweight Using Novel Dietary Strategies
The study tests the effectiveness for weight loss and weight maintenance of four diets differing in macronutrient composition: moderate in fat (40% energy) with two different protein levels (15% and 25%), and low in fat (20% energy), also with 15% and 25% protein levels.
Expérimental: diet 4
diet with low in fat (20% energy) and protein(25%)
Autre: Preventing Overweight Using Novel Dietary Strategies
The study tests the effectiveness for weight loss and weight maintenance of four diets differing in macronutrient composition: moderate in fat (40% energy) with two different protein levels (15% and 25%), and low in fat (20% energy), also with 15% and 25% protein levels.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Test the interactions between the genes and diet interventions varying in macronutrient intake on body weight changes(weight in kilograms) .
Délai: measured at Year 2
measured at Year 2

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Test the interactions between the genes and diet interventions varying in macronutrient intake on glycemic changes (mg/dL for fasting glucose,uU/mL for fasting insulin).
Délai: measured at Year 2
measured at Year 2
Test the interactions between the genes and diet interventions varying in macronutrient intake on waist circumference changes (cm).
Délai: measured at Year 2
measured at Year 2
Test the interactions between the genes and diet interventions varying in macronutrient intake on visceral fat changes (%).
Délai: measured at Year 2
measured at Year 2
Test the interactions between the genes and diet interventions varying in macronutrient intake on lipids changes (mg/dL for Total cholesterol, HDL cholesterol, LDL cholesterol and Triglycerides).
Délai: measured at Year 2
measured at Year 2
Test the interactions between the genes and diet interventions varying in macronutrient intake on bone health (Bone mineral density at different skeletal sites).
Délai: measured at Year 2
Bone mineral density was measured by dual-energy X-ray (DEXA)
measured at Year 2

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Ectopic fat
Délai: 2 year (measured at baseline, 6 months, and 2 years)
Computed tomography (CT) measured hepatic fat, abdominal fat distribution (includes visercal adipose tissue, subcutaneous adipose tissue, and total adipose tissue)
2 year (measured at baseline, 6 months, and 2 years)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Tulane University

Collaborateurs

Brigham and Women's Hospital

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 septembre 2003

Achèvement primaire (Réel)

1 décembre 2010

Achèvement de l'étude (Réel)

1 décembre 2010

Dates d'inscription aux études

Première soumission

11 août 2017

Première soumission répondant aux critères de contrôle qualité

21 août 2017

Première publication (Réel)

23 août 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

29 août 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 août 2019

Dernière vérification

1 août 2019

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • R01DK091718 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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