NCT01856660

Brief Summary

Individual food preferences are not considered in designing weight-loss therapies. This project will determine if short-term weight-loss is improved by matching participants with diets that reflect their genetically-determined food preferences.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable obesity

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

Study Start

First participant enrolled

September 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 17, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 24, 2021

Status Verified

August 1, 2021

Enrollment Period

2.7 years

First QC Date

May 14, 2013

Last Update Submit

August 23, 2021

Conditions

Keywords

ObesityWeight LossBody Weight ChangeTasteTaste PhenotypeLifestyle Intervention

Outcome Measures

Primary Outcomes (1)

  • Weight Loss

    Change in weight (Kg)

    0, 3 months, and 6 months

Secondary Outcomes (1)

  • Diet

    0, 3 months, and 6 months

Other Outcomes (2)

  • Physical Activity

    0, 3 months, and 6 months

  • Eating Attitudes

    0, 3 months, and 6 months

Study Arms (2)

Low-Fat Diet

EXPERIMENTAL

Participants are provided with a 6-month standard lifestyle intervention. They will follow an energy restricted, low-fat diet where the daily energy consumption target is 1,200- 1,500 kilocalories/d. The fat intake target is 28% or less of daily kilocalories. Gradual increase in physical activity until participants are active at least 40 min per day, 5 times/week.

Behavioral: Low-fat Diet

Low-Carbohydrate Diet

EXPERIMENTAL

Participants are provided with a 6-month standard lifestyle intervention. They will follow a low-carbohydrate diet where the daily carbohydrate target is 50g/d. There is no energy restriction. Gradual increase in physical activity until participants are active at least 40 min per day, 5 times/week.

Behavioral: Low-Carbohydrate Diet

Interventions

Participants are provided with a 6-month standard lifestyle intervention where carbohydrate intake is limited to 50 g/day. There is no calorie restriction for participants following the Low-Carbohydrate diet. Gradual increase in physical activity across the trial to \> 40 min per day, 5 times/week.

Low-Carbohydrate Diet
Low-fat DietBEHAVIORAL

Participants are provided with a 6-month standard lifestyle intervention. They will follow an energy restricted, low-fat diet where the daily energy consumption target is 1,200- 1,500 kilocalories/d. The fat intake target is 28% or less of daily kilocalories. Gradual increase in physical activity until participants are active at least 40 min per day, 5 times/week.

Low-Fat Diet

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index (BMI) between 27 and 40 kg/m squared No weight loss for 3 months prior to the study Stable hypertension, dyslipemia or Type 2 diabetes - with permission from primary care provider Oral therapy to treat Type 2 diabetes - with permission from primary care provider.
  • Able to walk 2 block without stopping

You may not qualify if:

  • Pregnant, lactating or planning to become pregnant during the trial History of cardiovascular disease (infarct, angina, arrhythmia or stroke) Recent chemotherapy or radiation therapy Liver, renal or thyroid disease Concurrent or recent (last 6 months) participation in any other weight loss intervention Insulin injection Medications to control appetite or weight Major psychiatric illnesses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rutgers University, Department of Food Science

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (2)

  • Burgess B, Raynor HA, Tepper BJ. PROP Nontaster Women Lose More Weight Following a Low-Carbohydrate Versus a Low-Fat Diet in a Randomized Controlled Trial. Obesity (Silver Spring). 2017 Oct;25(10):1682-1690. doi: 10.1002/oby.21951. Epub 2017 Aug 25.

  • Burgess B, Rao SP, Tepper BJ. Changes in liking for sweet and fatty foods following weight loss in women are related to prop phenotype but not to diet. Obesity (Silver Spring). 2016 Sep;24(9):1867-73. doi: 10.1002/oby.21570. Epub 2016 Jul 19.

MeSH Terms

Conditions

ObesityWeight LossBody Weight Changes

Interventions

Diet, Carbohydrate-RestrictedDiet, Fat-Restricted

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Beverly J Tepper, PhD

    Rutgers University, Deptartment of Food Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Professor

Study Record Dates

First Submitted

May 14, 2013

First Posted

May 17, 2013

Study Start

September 1, 2012

Primary Completion

June 1, 2015

Study Completion

August 1, 2016

Last Updated

August 24, 2021

Record last verified: 2021-08

Locations