Overview

This trial is active, not recruiting.

Conditions obesity, weight loss
Treatments low-carbohydrate diet, low-fat diet
Sponsor Rutgers University
Start date September 2012
End date December 2015
Trial size 160 participants
Trial identifier NCT01856660, AHA12060259

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(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.
low-fat diet
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.
(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.
low-carbohydrate diet
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.

Primary Outcomes

Measure
Weight Loss
time frame: 0, 3 months, and 6 months

Secondary Outcomes

Measure
Diet
time frame: 0, 3 months, and 6 months

Eligibility Criteria

Female participants from 18 years up to 60 years old.

Inclusion Criteria: 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 Exclusion Criteria: 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

Additional Information

Official title Bitter Taste Phenotype as an Adjunct to Behavioral Weight-loss Intervention in Women
Principal investigator Beverly J Tepper, PhD
Description Dislike of the diet is a common complaint in weight loss therapy that contributes to poor outcomes. Ironically, individual food preferences are rarely taken into account in designing weight-loss interventions. In the proposed research, we will utilize genetically-determined differences in food preferences, indexed by PROP bitter taste phenotype to develop a novel approach to weight loss therapy. The overall goal of this project is to determine if weight loss following a 6 month intervention can be substantially improved by matching participants with diets that reflect their genetically-determined food preferences. The study is designed as a randomized clinical weight-loss intervention trial in women in which PROP non-tasters and super-tasters. will be randomized to either the low-carbohydrate or the low-fat diet condition
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Rutgers University.