Bitter Taste and Weight Loss in Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Rutgers University
Sponsor:
Information provided by (Responsible Party):
Beverly J Tepper, Rutgers University
ClinicalTrials.gov Identifier:
NCT01856660
First received: May 14, 2013
Last updated: NA
Last verified: May 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Obesity
Weight Loss
Behavioral: Low-Carbohydrate Diet
Behavioral: Low-fat Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bitter Taste Phenotype as an Adjunct to Behavioral Weight-loss Intervention in Women

Resource links provided by NLM:


Further study details as provided by Rutgers University:

Primary Outcome Measures:
  • Weight Loss [ Time Frame: 0, 3 months, and 6 months ] [ Designated as safety issue: No ]
    Change in weight (Kg)


Secondary Outcome Measures:
  • Diet [ Time Frame: 0, 3 months, and 6 months ] [ Designated as safety issue: No ]
    4-day diet records will be assessed for kilocalories and macronutrients


Other Outcome Measures:
  • Physical Activity [ Time Frame: 0, 3 months, and 6 months ] [ Designated as safety issue: No ]
    Physical activity energy expenditure will be assessed by activity monitor

  • Eating Attitudes [ Time Frame: 0, 3 months, and 6 months ] [ Designated as safety issue: No ]
    Eating attitudes will be assessed with the Three-Factor Eating Questionnaire


Estimated Enrollment: 160
Study Start Date: September 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01856660

Contacts
Contact: Beverly J Tepper, PhD 848-932-5417 tepper@aesop.rutgers.edu

Locations
United States, New Jersey
Rutgers University, Department of Food Science Recruiting
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Rutgers University
Investigators
Principal Investigator: Beverly J Tepper, PhD Rutgers University, Deptartment of Food Science
  More Information

No publications provided

Responsible Party: Beverly J Tepper, PhD, Professor, Rutgers University
ClinicalTrials.gov Identifier: NCT01856660     History of Changes
Other Study ID Numbers: AHA12060259
Study First Received: May 14, 2013
Last Updated: May 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers University:
Obesity
Weight Loss
Body Weight Change
Taste
Taste Phenotype
Lifestyle Intervention

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on August 21, 2014