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Completed

NCT Number: NCT01856660

Bitter Taste and Weight Loss 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.

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers University, Department of Food Science

New Brunswick, New Jersey, 08901, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-Carbohydrate Diet

Behavioral

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-Fat Diet

Behavioral

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.

Primary outcomes

  1. Weight Loss

    Time frame: 0, 3 months, and 6 months

    Change in weight (Kg)

Secondary outcomes

  1. Diet

    Time frame: 0, 3 months, and 6 months

    4-day diet records will be assessed for kilocalories and macronutrients

Other outcomes

  1. Physical Activity

    Time frame: 0, 3 months, and 6 months

    Physical activity energy expenditure will be assessed by activity monitor

  2. Eating Attitudes

    Time frame: 0, 3 months, and 6 months

    Eating attitudes will be assessed with the Three-Factor Eating Questionnaire

Sponsors and collaborators

Lead sponsor

Rutgers University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
May 17, 2013
Registry last updated
Aug 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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