ObesityNCT01856660
Bitter Taste and Weight Loss in Women
A study testing Low-Carbohydrate Diet and Low-fat Diet in people with Obesity and Weight Loss, run by Rutgers University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Loss
- What is being tested?
- Low-Carbohydrate Diet and Low-fat Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers University, Department of Food Science
New Brunswick, New Jersey, 08901
About this study
Official title: 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.
Read the 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
- Conditions
- Obesity, Weight Loss
- Being tested
- Low-Carbohydrate Diet, Low-fat Diet
- Keywords
- Obesity, Weight Loss, Body Weight Change, Taste, Taste Phenotype, Lifestyle Intervention
- Medical subject headings
- Obesity, Weight Loss, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Carbohydrate DietBehavioural
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 DietBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Low-Fat Diet | 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. Receives: Behavioral: Low-fat Diet |
| Low-Carbohydrate Diet | 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. Receives: Behavioral: Low-Carbohydrate Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
Change in weight (Kg)
Measured: 0, 3 months, and 6 months
Secondary outcomes (1)
Diet
4-day diet records will be assessed for kilocalories and macronutrients
Measured: 0, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2013 (estimated)
- Study startSep 2012
- Primary completionJun 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beverly J Tepper, Ph.D., Rutgers University
- Investigators
- Beverly J Tepper, PhD, Principal investigator, Rutgers University, Deptartment of Food Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01856660
- Sponsor's protocol ID
- AHA12060259
- Status last verified
- Aug 2021
- First submitted
- 14 May 2013
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28841772Burgess 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.
PubMed 27430708
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bitter Taste Phenotype as an Adjunct to Behavioral Weight-loss Intervention in Women
- ClinicalTrials.gov ID
- NCT01856660
- Acronym / sponsor ID
- AHA12060259
- Conditions
- Obesity, Weight Loss
- Keywords
- Obesity, Weight Loss, Body Weight Change, Taste, Taste Phenotype, Lifestyle Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Rutgers UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 17 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Fat Diet | Experimental | Behavioral: Low-fat DietParticipants 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-Carbohydrate Diet | Experimental | Behavioral: Low-Carbohydrate DietParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Carbohydrate DietParticipants 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. | Behavioural | Low-Carbohydrate Diet |
| Low-fat DietParticipants 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. | Behavioural | Low-Fat Diet |
Primary outcome
Weight Loss
Time frame: 0, 3 months, and 6 months
Change in weight (Kg)
1 secondary outcome
Diet
Time frame: 0, 3 months, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Derived from this study: PubMed 28841772Burgess 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.
- Derived from this study: PubMed 27430708Burgess 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beverly J Tepper, PhD principal investigator
Rutgers University, Deptartment of Food Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Carbohydrate Diet and Low-fat Diet in people with Obesity and Weight Loss, run by Rutgers University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Loss (time frame: 0, 3 months, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01856660, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.