Back to resultsBitter Taste and Weight Loss in Women
Primary Purpose
Obesity, Weight Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-Carbohydrate Diet
Low-fat Diet
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Weight Loss, Body Weight Change, Taste, Taste Phenotype, Lifestyle Intervention
Eligibility 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
Sites / Locations
- Rutgers University, Department of Food Science
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Low-Fat Diet
Low-Carbohydrate Diet
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Weight Loss
Change in weight (Kg)
Secondary Outcome Measures
Diet
4-day diet records will be assessed for kilocalories and macronutrients
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01856660
Brief Title
Bitter Taste and Weight Loss in Women
Official Title
Bitter Taste Phenotype as an Adjunct to Behavioral Weight-loss Intervention in Women
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss
Keywords
Obesity, Weight Loss, Body Weight Change, Taste, Taste Phenotype, Lifestyle Intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low-Fat Diet
Arm Type
Experimental
Arm Description
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.
Arm Title
Low-Carbohydrate Diet
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Low-Carbohydrate Diet
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Low-fat Diet
Intervention Description
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 Outcome Measure Information:
Title
Weight Loss
Description
Change in weight (Kg)
Time Frame
0, 3 months, and 6 months
Secondary Outcome Measure Information:
Title
Diet
Description
4-day diet records will be assessed for kilocalories and macronutrients
Time Frame
0, 3 months, and 6 months
Other Pre-specified Outcome Measures:
Title
Physical Activity
Description
Physical activity energy expenditure will be assessed by activity monitor
Time Frame
0, 3 months, and 6 months
Title
Eating Attitudes
Description
Eating attitudes will be assessed with the Three-Factor Eating Questionnaire
Time Frame
0, 3 months, and 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beverly J Tepper, PhD
Organizational Affiliation
Rutgers University, Deptartment of Food Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers University, Department of Food Science
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28841772
Citation
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.
Results Reference
derived
PubMed Identifier
27430708
Citation
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.
Results Reference
derived
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Bitter Taste and Weight Loss in Women
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