Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-01-01 @ 4:42 PM
Study NCT ID:
NCT00932750
Status:
COMPLETED
Last Update Posted:
2012-08-22
First Post:
2009-07-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Coffee Mannooligosaccharides for Weight Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], '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'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-21', 'studyFirstSubmitDate': '2009-07-02', 'studyFirstSubmitQcDate': '2009-07-02', 'lastUpdatePostDateStruct': {'date': '2012-08-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Composition by Magnetic Resonance Imaging', 'timeFrame': 'Baseline and Endpoint'}, {'measure': 'Blood pressure', 'timeFrame': 'Weekly'}, {'measure': 'Body weight', 'timeFrame': 'Weekly'}, {'measure': 'Waist circumference', 'timeFrame': 'Weekly'}], 'secondaryOutcomes': [{'measure': 'Appetite/Satiety', 'timeFrame': 'Weekly'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Body composition', 'Weight loss', 'Weight management', 'Beverages', 'Diet'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to establish the role of coffee mannooligosaccharides (MOS), provided in a beverage format, on body weight regulation. Overweight and obese men and women will be randomized to one of 2 groups: placebo or MOS beverage. They will be required to consume 2 beverages/day for the duration of the 2 phases of the study. The MOS beverage will provide 2 g of MOS (total of 4 g/d). This dose level has been found to be well tolerated and safe. In the first phase, subjects will be counseled once monthly on a nutrition-related topic on an individual basis. They will be asked to maintain their regular eating and exercise habits for the duration of the 12 week period. An 8-week washout period will follow during which time they will not be required to consume the beverages. The second phase of the study will be a weight loss phase. For this phase, subjects will be re-randomized and may consume the alternate or the same beverage as the first phase, depending on the outcome of randomization. During this phase, they will undergo group counseling on a weekly basis. Counseling sessions will focus on weight loss and ways to achieve moderate weight loss of approximately 1-2 lbs/week. Measurements will be taken at the beginning and end of each phase. This study will allow us to determine whether MOS helps maintain body weight and prevent weight gain (first phase) and whether it helps to stimulate weight loss (second phase). The results will allow us to find ways in which overweight and obese individuals can incorporate beverages in their diets that will help promote weight loss.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index 27-33 kg/m2\n* Stable body weight\n\nExclusion Criteria:\n\n* Body width \\> 46 cm\n* Medications known to affect body weight, lipids, blood pressure\n* Pregnant or lactating women\n* Less than 1 y post-partum'}, 'identificationModule': {'nctId': 'NCT00932750', 'acronym': 'MOS', 'briefTitle': 'Study of Coffee Mannooligosaccharides for Weight Management', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mondelēz International, Inc.'}, 'officialTitle': 'THE EFFECTS OF COFFEE MANNOOLIGOSACCHARIDES ON INDICES OF BODY WEIGHT, BODY COMPOSITION, AND SATIETY IN HUMANS', 'orgStudyIdInfo': {'id': 'KF-MOS-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'MOS Weight maintenance', 'interventionNames': ['Dietary Supplement: Coffee mannooligosaccharide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'MOS weight loss', 'interventionNames': ['Dietary Supplement: Coffee mannooligosaccharides']}], 'interventions': [{'name': 'Coffee mannooligosaccharide', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 beverages daily providing either 4 g of coffee mannooligosaccharide or placebo.', 'armGroupLabels': ['MOS Weight maintenance']}, {'name': 'Coffee mannooligosaccharides', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Subjects consume 2 beverages daily providing 4 g of coffee mannooligosaccharides or placebo', 'armGroupLabels': ['MOS weight loss']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10025', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "St. Luke's/Roosevelt Hospital", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Marie-Pierre St-Onge, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Luke's-Roosevelt Hospital Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mondelēz International, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': "St. Luke's-Roosevelt Hospital Center", 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Marie-Pierre St-Onge, Ph.D Research Associate', 'oldOrganization': "St. Luke's/Roosevelt Hospital"}}}}