NCT00493701

Brief Summary

This study is designed to predict weight gain overtime after a high fat diet.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2007

Completed
9 years until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2020

Completed
Last Updated

September 15, 2022

Status Verified

September 1, 2022

Enrollment Period

3.7 years

First QC Date

June 26, 2007

Last Update Submit

September 13, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Characteristics of Individuals

    Characterize the biochemical, endocrine, anthropometric and environmental characteristics of individuals with the "thrifty" phenotype.

    4 days of high fat diet

Secondary Outcomes (1)

  • Identify the Signaling Pathways

    4 days after high fat diet

Study Arms (2)

Lifestyle

OTHER

Measurement of body weight in a fown with light undercloting (30 minutes) and height.

Behavioral: High Fat Diet

DEXA Scanner

OTHER

Low-dose X0rays to determine the amount of fat, bone and muscle in your body.

Behavioral: Low Fat Diet

Interventions

High Fat DietBEHAVIORAL

Daily eating

Also known as: Measurements will be collected to help with gathering data.
Lifestyle
Low Fat DietBEHAVIORAL

Life style eating habits

Also known as: Questionnairs of food frequency
DEXA Scanner

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Both genders and all races will be invited to participate
  • Women will be asked to participate in the follicular phase of the menstrual cycle as determined by menstrual history and a negative pregnancy test will be recorded prior to participation
  • BMI \> 19 and \< 35

You may not qualify if:

  • Smokers
  • Unwilling or unable to abstain from alcohol consumption and caffeine consumption prior to testing and laboratory
  • Significant renal, hepatic, endocrine, pulmonary, cardiac or hematological disease
  • Pregnancy
  • Corticosteroid use in previous two months
  • Chronic use of anti-diabetic, anti-hypertensive, or other medications known to affect fat metabolism
  • Use of Depo-Provera, hormone implants or estrogen replacement therapy
  • Irregular menstrual cycles
  • Post-menopausal women
  • Weight gain or loss of \> 3kg in the last 6 months
  • Individuals who have a heart pacemaker, defibrillator, or non-removable hearing aid
  • Individuals with any clips or metal plates in their head
  • Individuals who have any artificial limbs or prosthetic devices
  • Individuals who were ever injured by a metallic foreign body which was not removed
  • Individuals, who wear braces on their teeth, have non-removable false teeth, or removable bridgework

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (2)

  • Lam YY, Redman LM, Smith SR, Bray GA, Greenway FL, Johannsen D, Ravussin E. Determinants of sedentary 24-h energy expenditure: equations for energy prescription and adjustment in a respiratory chamber. Am J Clin Nutr. 2014 Apr;99(4):834-42. doi: 10.3945/ajcn.113.079566. Epub 2014 Feb 5.

    PMID: 24500151DERIVED

  • Pasarica M, Xie H, Hymel D, Bray G, Greenway F, Ravussin E, Smith SR. Lower total adipocyte number but no evidence for small adipocyte depletion in patients with type 2 diabetes. Diabetes Care. 2009 May;32(5):900-2. doi: 10.2337/dc08-2240. Epub 2009 Feb 19.

    PMID: 19228873DERIVED

MeSH Terms

Interventions

Diet, High-FatDiet, Fat-Restricted

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDiet TherapyNutrition TherapyTherapeutics

Study Officials

  • Steven R Smith, M.D.

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2007

First Posted

June 28, 2007

Study Start

July 1, 2016

Primary Completion

March 4, 2020

Study Completion

March 4, 2020

Last Updated

September 15, 2022

Record last verified: 2022-09

Locations

US(1)