Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-01-24 @ 12:27 PM
Study NCT ID:
NCT01856660
Status:
COMPLETED
Last Update Posted:
2021-08-24
First Post:
2013-05-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bitter Taste and Weight Loss in Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D001836', 'term': 'Body Weight Changes'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050528', 'term': 'Diet, Carbohydrate-Restricted'}, {'id': 'D018752', 'term': 'Diet, Fat-Restricted'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-23', 'studyFirstSubmitDate': '2013-05-14', 'studyFirstSubmitQcDate': '2013-05-14', 'lastUpdatePostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Physical Activity', 'timeFrame': '0, 3 months, and 6 months', 'description': 'Physical activity energy expenditure will be assessed by activity monitor'}, {'measure': 'Eating Attitudes', 'timeFrame': '0, 3 months, and 6 months', 'description': 'Eating attitudes will be assessed with the Three-Factor Eating Questionnaire'}], 'primaryOutcomes': [{'measure': 'Weight Loss', 'timeFrame': '0, 3 months, and 6 months', 'description': 'Change in weight (Kg)'}], 'secondaryOutcomes': [{'measure': 'Diet', 'timeFrame': '0, 3 months, and 6 months', 'description': '4-day diet records will be assessed for kilocalories and macronutrients'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity', 'Weight Loss', 'Body Weight Change', 'Taste', 'Taste Phenotype', 'Lifestyle Intervention'], 'conditions': ['Obesity', 'Weight Loss']}, 'referencesModule': {'references': [{'pmid': '28841772', 'type': 'DERIVED', '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.'}, {'pmid': '27430708', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBody 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.\n\nAble to walk 2 block without stopping\n\nExclusion Criteria:\n\nPregnant, 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'}, 'identificationModule': {'nctId': 'NCT01856660', 'briefTitle': 'Bitter Taste and Weight Loss in Women', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Bitter Taste Phenotype as an Adjunct to Behavioral Weight-loss Intervention in Women', 'orgStudyIdInfo': {'id': 'AHA12060259'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low-Fat Diet', '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.', 'interventionNames': ['Behavioral: Low-fat Diet']}, {'type': 'EXPERIMENTAL', 'label': 'Low-Carbohydrate Diet', '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.', 'interventionNames': ['Behavioral: Low-Carbohydrate Diet']}], 'interventions': [{'name': 'Low-Carbohydrate Diet', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Low-Carbohydrate Diet']}, {'name': 'Low-fat Diet', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Low-Fat Diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers University, Department of Food Science', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}], 'overallOfficials': [{'name': 'Beverly J Tepper, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers University, Deptartment of Food Science'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, Professor', 'investigatorFullName': 'Beverly J Tepper, Ph.D.', 'investigatorAffiliation': 'Rutgers University'}}}}