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

26 augustus 2019 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

811

Fase

  • Niet toepasbaar

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

30 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Faculteitstoewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: diet 1
diet with moderate in fat (40% energy) and protein(15%)
Ander: 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.
Experimenteel: diet 2
diet with moderate in fat (40% energy) and protein(25%)
Ander: 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.
Experimenteel: diet 3
diet with low in fat (20% energy) and protein(15%)
Ander: 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.
Experimenteel: diet 4
diet with low in fat (20% energy) and protein(25%)
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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).
Tijdsspanne: 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).
Tijdsspanne: 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 (%).
Tijdsspanne: 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).
Tijdsspanne: 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).
Tijdsspanne: measured at Year 2
Bone mineral density was measured by dual-energy X-ray (DEXA)
measured at Year 2

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Ectopic fat
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Tulane University

Medewerkers

Brigham and Women's Hospital

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 september 2003

Primaire voltooiing (Werkelijk)

1 december 2010

Studie voltooiing (Werkelijk)

1 december 2010

Studieregistratiedata

Eerst ingediend

11 augustus 2017

Eerst ingediend dat voldeed aan de QC-criteria

21 augustus 2017

Eerst geplaatst (Werkelijk)

23 augustus 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 augustus 2019

Laatste update ingediend die voldeed aan QC-criteria

26 augustus 2019

Laatst geverifieerd

1 augustus 2019

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • R01DK091718 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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