Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2026-02-22 @ 9:36 AM
Study NCT ID:
NCT01257295
Status:
COMPLETED
Last Update Posted:
2011-12-26
First Post:
2010-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Properties of Dietary Fibre and Energy Intake
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D062408', 'term': 'Breakfast'}], 'ancestors': [{'id': 'D062407', 'term': 'Meals'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-23', 'studyFirstSubmitDate': '2010-12-08', 'studyFirstSubmitQcDate': '2010-12-08', 'lastUpdatePostDateStruct': {'date': '2011-12-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'energy intake', 'timeFrame': '3 hours', 'description': '3 hours after ingesting the test breakfast ad libitum energy intake is measured.'}], 'secondaryOutcomes': [{'measure': 'appetite sensations', 'timeFrame': '3 hours', 'description': 'appetite is measured by VAS scales over a period of 3 hours after ingestion of a test breakfast'}, {'measure': 'satiety hormones', 'timeFrame': '3 hours', 'description': 'satiety hormones (ghrelin, PYY, GLP-1, CCK) are measured over a period of 3 hours after ingestion of a test breakfast'}, {'measure': 'gastric emptying rate', 'timeFrame': '3 hours', 'description': 'gastric emptying rate is measured over a period of 3 hours after ingestion of a test breakfast'}, {'measure': 'method of supplementation', 'timeFrame': '3 hours', 'description': 'One of the fibers will be offered as tablets that will be ingested with a glass of water right after the test meal.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dietary fiber', 'energy intake', 'appetite', 'satiety hormones', 'glucose', 'gastric emptying'], 'conditions': ['Healthy Male Subjects']}, 'descriptionModule': {'briefSummary': 'Dietary fibers likely have a role in body weight management. They may increase satiety and, as a consequence, reduce energy intake during the next meal. There are, however, many different types of dietary fiber, which have diverse physical properties and can therefore impact these outcomes differently. It is, however, unclear whether dietary fibers with different properties lead to differences in energy intake during the next meal. The objective of this study is to study the effect of pectin in 4 different physicochemical states on ad libitum energy intake and possible underlying mechanisms; i.e. gastrointestinal hormones, gastric emptying rate, feelings of satiety and the method of fiber supplementation. We hypothesize that viscous and gelling fibers will reduce ad libitum energy intake compared to low viscous and low gelling fibers.'}, 'eligibilityModule': {'sex': 'MALE', '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\nExclusion Criteria:\n\n* Females\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: \\>2.89, measured by DEBQ (35).\n* Smoking\n* Heavy alcohol use: \\>5 drinks/day (36).\n* Reported stomach or bowel disease\n* Reported diabetes\n* Reported thyroid disease or any other endocrine disorder\n* Reported intolerance for pectin, bread, gluten, dairy or not liking of the research foods\n* Anemia: Hb\\<8.0 mmol/l\n* Fasting glucose levels \\>5.8 mmol/l\n* Blood donation from 6 weeks prior to the study until the end of the study\n* Experienced any problems with drawing blood in the past\n* Antecubital veins not considered suitable for blood drawing by means of a catheter\n* Thesis students or employees of the division of Human Nutrition'}, 'identificationModule': {'nctId': 'NCT01257295', 'acronym': 'ProVe', 'briefTitle': 'Properties of Dietary Fibre and Energy Intake', 'organization': {'class': 'OTHER', 'fullName': 'Wageningen University'}, 'officialTitle': 'Properties of Dietary Fibre and Energy Intake: an Intervention to Study the Effect of Physicochemical Properties of Dietary Fibre on Energy Intake and Underlying Mechanisms', 'orgStudyIdInfo': {'id': 'METC-10/22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'No additions of fiber to a breakfast meal', 'interventionNames': ['Dietary Supplement: control: no fiber addition']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'low viscous, low gelling', 'description': 'low viscous, low gelling fibre added to breakfast meal', 'interventionNames': ['Dietary Supplement: breakfast with low viscous, low gelling pectin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'high viscous, low gelling', 'description': 'high viscous, low gelling fibre added to breakfast meal', 'interventionNames': ['Dietary Supplement: high viscous, low gelling pectin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'low viscous, high gelling', 'description': 'low viscous, high gelling fibre added to breakfast meal', 'interventionNames': ['Dietary Supplement: low viscous, high gelling pectin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'high viscous, high gelling', 'description': 'high viscous, high gelling fibre added to breakfast meal', 'interventionNames': ['Dietary Supplement: high viscous, high gelling pectin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'fibre supplement', 'description': 'high viscous, high gelling fibre is added, not to the breakfast meal, but as supplement', 'interventionNames': ['Dietary Supplement: pectin supplement']}], 'interventions': [{'name': 'control: no fiber addition', 'type': 'DIETARY_SUPPLEMENT', 'description': 'liquid breakfast without addition of fiber', 'armGroupLabels': ['control']}, {'name': 'breakfast with low viscous, low gelling pectin', 'type': 'DIETARY_SUPPLEMENT', 'description': '10g of low viscous, low gelling pectin dissolved in a liquid breakfast', 'armGroupLabels': ['low viscous, low gelling']}, {'name': 'high viscous, low gelling pectin', 'type': 'DIETARY_SUPPLEMENT', 'description': '10g of high viscous, low gelling pectin dissolved in a liquid breakfast', 'armGroupLabels': ['high viscous, low gelling']}, {'name': 'low viscous, high gelling pectin', 'type': 'DIETARY_SUPPLEMENT', 'description': '10g of low viscous, high gelling pectin dissolved in a liquid breakfast', 'armGroupLabels': ['low viscous, high gelling']}, {'name': 'high viscous, high gelling pectin', 'type': 'DIETARY_SUPPLEMENT', 'description': '10g of high viscous, high gelling pectin dissolved in a liquid breakfast', 'armGroupLabels': ['high viscous, high gelling']}, {'name': 'pectin supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': '10g of high viscous, high gelling pectin provided as a dietary supplement, a liquid breakfast is served seperately', 'armGroupLabels': ['fibre supplement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6702', 'city': 'Wageningen', 'country': 'Netherlands', 'facility': 'Wageningen University', 'geoPoint': {'lat': 51.97, 'lon': 5.66667}}], 'overallOfficials': [{'name': 'Edith Feskens, PHd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wageningen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wageningen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}