Bitter Taste and Weight Loss in Women

August 23, 2021 updated by: Beverly J Tepper, Ph.D., Rutgers University

Bitter Taste Phenotype as an Adjunct to Behavioral Weight-loss Intervention in Women

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers University, Department of Food Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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: Low-Carbohydrate Diet
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight Loss
Time Frame: 0, 3 months, and 6 months
Change in weight (Kg)
0, 3 months, and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diet
Time Frame: 0, 3 months, and 6 months
4-day diet records will be assessed for kilocalories and macronutrients
0, 3 months, and 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Activity
Time Frame: 0, 3 months, and 6 months
Physical activity energy expenditure will be assessed by activity monitor
0, 3 months, and 6 months
Eating Attitudes
Time Frame: 0, 3 months, and 6 months
Eating attitudes will be assessed with the Three-Factor Eating Questionnaire
0, 3 months, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers University

Investigators

  • Principal Investigator: Beverly J Tepper, PhD, Rutgers University, Deptartment of Food Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

May 14, 2013

First Submitted That Met QC Criteria

May 14, 2013

First Posted (Estimate)

May 17, 2013

Study Record Updates

Last Update Posted (Actual)

August 24, 2021

Last Update Submitted That Met QC Criteria

August 23, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHA12060259

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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