Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2026-01-07 @ 4:37 AM
Study NCT ID:
NCT01526759
Status:
COMPLETED
Last Update Posted:
2012-03-12
First Post:
2011-12-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fiber Longer Term Study on Energy Intake
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018761', 'term': 'Multiple Endocrine Neoplasia Type 1'}], 'ancestors': [{'id': 'D009377', 'term': 'Multiple Endocrine Neoplasia'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009378', 'term': 'Neoplasms, Multiple Primary'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005780', 'term': 'Gelatin'}], 'ancestors': [{'id': 'D012596', 'term': 'Scleroproteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-09', 'studyFirstSubmitDate': '2011-12-23', 'studyFirstSubmitQcDate': '2012-02-01', 'lastUpdatePostDateStruct': {'date': '2012-03-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Energy intake', 'timeFrame': 'change from placebo after 2 weeks', 'description': 'after 14 days of both intervention and placebo supplements ad libitum energy intake is measured for 3 days in a row. The change in energy intake will be calculated.'}], 'secondaryOutcomes': [{'measure': 'satiety', 'timeFrame': 'change from placebo after 1 day and 15 days', 'description': 'at day 1 and after 15 days of both supplement and placebo intake satiety is measured hourly over 1 day at waking hours. The change in satiety will be calculated.'}, {'measure': 'fasting glucose', 'timeFrame': 'change from placebo after day 0, 1 and 15', 'description': 'at day 0, 1 and day 15 of supplementation period fasting glucose is measured'}, {'measure': 'fasting insulin', 'timeFrame': 'change from placebo after day 0, 1 and 15', 'description': 'at day 0, 1 and day 15 of supplementation period fasting insulin is measured'}, {'measure': 'fasting leptin', 'timeFrame': 'change from placebo after day 0, 1 and 15', 'description': 'at day 0, 1 and day 15 of supplementation period fasting leptin is measured'}, {'measure': 'hydrogen in breath', 'timeFrame': 'change from placebo after day 2 and 15', 'description': 'at day 2 and at day 15 hydrogen is measured hourly over 1 day at waking hours'}, {'measure': 'energy intake', 'timeFrame': 'change from placebo after day 0 and 1', 'description': 'before supplement intake and after 1 day of supplement 1-day ad libitum energy intake is measured. The change in energy intake will be calculated.'}, {'measure': 'body weight', 'timeFrame': 'change from placebo after day 0,1,2,14,15, 16 and 17', 'description': 'Each day the subject reports to the research center, body weight is measured. The change in body weight compared to placebo will be calculated.'}, {'measure': 'adverse events', 'timeFrame': 'daily from day 0 to day 16', 'description': "participants will be asked to register adverse events daily in a diary. They are also asked to report ae's to the researchers. number and type of AEs after fibre supplements will be compared to number and type of AEs after placebo supplements"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['dietary fiber', 'energy intake', 'satiety', 'physicochemical properties', 'men and women', 'Healthy adults'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Dietary fibre seems to have a relevant role in body weight management. In an acute study the investigators found that high viscous-high gelling pectin increased feelings of satiety. The objective of this study is to study the effects of 2 weeks of supplementation of high gelling-high viscous fibre or a high gelling-high viscous non-fibre control on energy intake.\n\nThe investigators do this by measuring the difference in ad libitum energy intake after 15 days of pectin or 15 days of control supplements. The investigators will further measure differences in 24h feelings of satiety, fasting blood glucose and insulin, fermentation and composition of microbiota.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18-30 year\n* BMI: 18.5-25 kg/m2\n* Healthy: as judged by the participant\n* H2 producer\n\nExclusion Criteria:\n\n* Weight loss or weight gain of more than 5 kg during the last 2 months\n* Using an energy restricted diet during the last 2 months\n* Lack of appetite for any reason\n* Restrained eater\n* Smoking\n* Heavy alcohol use: \\>5 drinks/day\n* Reported stomach or bowel diseases or disorders (e.g. irritable bowel syndrome)\n* Reported diabetes\n* Reported thyroid disease or any other endocrine disorder\n* Using medication other than birth control, paracetamol, aspirin, hey fever and asthma\n* Antibiotic use \\<2 months before the study\n* Reported intolerance, allergy, or not liking of the research foods\n* Vegetarian\n* Current dietary fibre supplementation\n* Fasting glucose levels \\>5.8 mmol/l\n* Experienced any problems with drawing blood in the past\n* Thesis students or employees of the division of Human Nutrition\n* Volunteers who participated in the ProVe study'}, 'identificationModule': {'nctId': 'NCT01526759', 'acronym': 'FLiTS', 'briefTitle': 'Fiber Longer Term Study on Energy Intake', 'organization': {'class': 'OTHER', 'fullName': 'Wageningen University'}, 'officialTitle': 'The Effect of 2 Weeks of Supplementation of a High-gelling, High-viscous Dietary Fibre on Energy Intake', 'orgStudyIdInfo': {'id': 'NL38515.081.11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pectin', 'description': '10 gram high gelling-high viscous fiber, added to a drink', 'interventionNames': ['Dietary Supplement: LM pectin (10%)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': '10g gelatin, added to a drink', 'interventionNames': ['Dietary Supplement: gelatin']}], 'interventions': [{'name': 'LM pectin (10%)', 'type': 'DIETARY_SUPPLEMENT', 'description': '15 days 1 daily consumption of a drink with 10g pectin added', 'armGroupLabels': ['pectin']}, {'name': 'gelatin', 'type': 'DIETARY_SUPPLEMENT', 'description': '15 days 1 daily consumption of a drink with 10g gelatin added', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7002HD', 'city': 'Wageningen', 'country': 'Netherlands', 'facility': 'Wageningen University', 'geoPoint': {'lat': 51.97, 'lon': 5.66667}}], 'overallOfficials': [{'name': 'Edith Feskens, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wageningen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wageningen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}