Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2026-02-25 @ 6:29 PM
Study NCT ID:
NCT02035150
Status:
COMPLETED
Last Update Posted:
2014-01-14
First Post:
2014-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Different Fiber Breakfasts on Appetite and Weight Change in Overweight Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2002-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-10', 'studyFirstSubmitDate': '2014-01-08', 'studyFirstSubmitQcDate': '2014-01-10', 'lastUpdatePostDateStruct': {'date': '2014-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'At baseline and following 4-week intervention', 'description': 'Systolic and diastolic blood pressure will be measured at baseline and following 4-week intervention'}], 'primaryOutcomes': [{'measure': 'Change in body weight', 'timeFrame': 'Change in body weight over 4 week intervention', 'description': 'Body weight will be measured at baseline and following 4-week breakfast intervention'}], 'secondaryOutcomes': [{'measure': 'Subjective appetite', 'timeFrame': 'Appetite ratings in response to breakfast will be collected for 3hs on the first day of the study and after 1, 2, 3 and 4 weeks of the intervention', 'description': 'Ratings of hunger and Fullness will be collected on a 6 point rating scale with 0 labelled not at all, 40 moderately, 60 quite, 80 very and 100 extremely.'}, {'measure': 'Change in plasma metabolic risk factors', 'timeFrame': 'At baseline and following 4-week intervention', 'description': 'A fasting blood sample will be collected and analyzed for glucose, insulin, triacylglycerol, leptin and cholesterol'}, {'measure': 'Resting Energy Expenditure', 'timeFrame': 'Resting energy expenditure will be measured at baseline and following the 4 week intervention', 'description': 'Resting energy expenditure measurements will be collected whilst subjects are fasting, resting in a semi-supine position under thermoneutral conditions with a ventilated hood and metabolic cart.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['breakfast', 'oatmeal', 'appetite', 'cholesterol'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'Regular breakfast consumption may help lower body weight reduce body fatness and improve cardiovascular disease risk factors. However, the best kind of breakfast to consume to achieve these effects is unclear. We hypothesized that a high fiber breakfast would suppress appetite, lower body weight and improve cardiovascular disease risk factors compared with a no-fiber breakfast.', 'detailedDescription': 'Participants will report to the hospital cafeteria between 0800 and 0900h following an overnight fast every weekday for 4 consecutive weeks. On arrival, participants will be provided will the allocated breakfast and will be given 15 min to consume all the foods provided. The oatmeal breakfast will consist of 80g dry oatmeal (Quaker Quick Oats) prepared with 120mL fat-free milk and 230mL water. The frosted flakes breakfast will consist of 62g frosted flakes and 160mL whole milk and 190mL water served on the side. The No-breakfast (control) will consist of only 350mL plain water. All participants will also receive 200mL decaffeinated coffee with 12mL non-dairy creamer and 1g packet of non-caloric sweetener. On Friday of each week participants will be provided with two portions of the breakfasts to take home at consume on the weekend days. On the first day of the intervention and weekly thereafter participants will complete 3hr subjective appetite ratings responses to the breakfast. Laboratory assessments including body weight, composition, blood pressure and a fasting blood sample will be collected before the start of the intervention and at the end of the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\>27kg/m2\n* Weight stable (\\<5% weight change in past 3 months)\n\nExclusion Criteria:\n\n* Smokers\n* Regular use of medications\n* Currently undertaking a weight-loss or exercise program\n* Females who are pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT02035150', 'briefTitle': 'Effect of Different Fiber Breakfasts on Appetite and Weight Change in Overweight Subjects', 'organization': {'class': 'OTHER', 'fullName': 'New York Obesity and Nutrition Research Center'}, 'officialTitle': 'The Effect of Ingesting Breakfasts Varying in Fiber on Appetite and Weight Change in Overweight Subjects', 'orgStudyIdInfo': {'id': '98-022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oatmeal Breakfast', 'description': 'Participants will consume oatmeal breakfast daily for 4 weeks', 'interventionNames': ['Dietary Supplement: Oatmeal']}, {'type': 'EXPERIMENTAL', 'label': 'Frosted Flakes', 'description': 'Participants will consume a frosted flakes breakfast daily for 4-weeks', 'interventionNames': ['Dietary Supplement: Frosted Flakes']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'No Breakfast', 'description': 'Participants will consume no breakfast for a 4-week period', 'interventionNames': ['Dietary Supplement: No Breakfast']}], 'interventions': [{'name': 'Oatmeal', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Quaker Quick Oats'], 'description': 'A breakfast consisting of oatmeal', 'armGroupLabels': ['Oatmeal Breakfast']}, {'name': 'Frosted Flakes', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Kelloggs Frosted Flakes'], 'description': 'A breakfast consisting of Frosted Flakes and milk', 'armGroupLabels': ['Frosted Flakes']}, {'name': 'No Breakfast', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A breakfast consisting of plain water', 'armGroupLabels': ['No Breakfast']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Allan Geliebter, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York Obesity Nutrition Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York Obesity and Nutrition Research Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'PepsiCo Global R&D', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Scientist', 'investigatorFullName': 'Dr. Allan Geliebter', 'investigatorAffiliation': 'New York Obesity and Nutrition Research Center'}}}}