Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT00776256
Status:
COMPLETED
Last Update Posted:
2008-10-21
First Post:
2008-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Oligofructose and Barley on Satiety and Energy Intake
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D047071', 'term': 'beta-Glucans'}, {'id': 'C116580', 'term': 'fructooligosaccharide'}, {'id': 'C120489', 'term': 'oligofructose'}], 'ancestors': [{'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-10-20', 'studyFirstSubmitDate': '2008-10-18', 'studyFirstSubmitQcDate': '2008-10-20', 'lastUpdatePostDateStruct': {'date': '2008-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Satiety and food intake', 'timeFrame': '2 days each week for 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['satiety', 'food intake'], 'conditions': ['Appetite Regulation']}, 'referencesModule': {'references': [{'pmid': '19056555', 'type': 'DERIVED', 'citation': 'Peters HP, Boers HM, Haddeman E, Melnikov SM, Qvyjt F. No effect of added beta-glucan or of fructooligosaccharide on appetite or energy intake. Am J Clin Nutr. 2009 Jan;89(1):58-63. doi: 10.3945/ajcn.2008.26701. Epub 2008 Dec 3.'}]}, 'descriptionModule': {'briefSummary': 'The effect of beta-glucan or fructo-oligosaccharide or their combination in bars on satiety and food intake was tested by supplying these bars on two consecutive days.', 'detailedDescription': 'Background: Increasing gastro-intestinal viscosity or colonic fermentation is suggested to help improve appetite control and reduce food intake. Beta-glucan (BG) and fructo-oligosaccharide (FOS) are food ingredients proposed to act this way, but results so far remain inconclusive.\n\nObjective: To test the effect of FOS, BG, or their combination in bars on appetite ratings and food intake during 2 consecutive days.\n\nDesign: In a 4-way balanced order cross-over double-blind design, 21 healthy volunteers (mean BMI 25.9 kg/m2) received a meal replacement bar at 09.00h and an ad libitum lunch at 13.00h on 2 consecutive days. On day 1 only, subjects consumed a second (identical) bar at 17.00h and a fixed snack at 19.00h. The control bar contained 0.3g BG (control, from 6.8 g oats), vs equi-caloric bar formulations containing an additional: 1) 0.9 g BG (from 8.0g barley), 2) 8g FOS, or 3) 0.9 g BG + 8g FOS. Appetite scores and subsequent ad libitum test meal intakes were measured. Bar viscosities were determined under simulated gastric conditions. Results were analyzed using ANCOVA.\n\nResults: Addition of BG, FOS or their combination did not affect appetite ratings or food intake, although addition of BG to the bar doubled apparent gastric viscosity (841 vs 351 mPa.s).\n\nConclusions: BG, FOS or their combination in bars at these levels do not improve appetite control when consumed on 2 consecutive days. Efficacy might be increased by a longer exposure period, increasing the BG content, or a form of BG that generates even higher gastric viscosity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age at start of the study 18 till 60 years\n* Quetelet-Index (BMI) from 21 till 32 kg/m2 inclusive\n* Apparently healthy: measured by questionnaire: no reported current or previous metabolic diseases or chronic gastrointestinal disorders\n* Reported dietary habits: no medically prescribed diet, no slimming diet, used to eat 3 meals a day, no vegetarian, macro-biotic or biologic dynamic food habits\n* No Fibre supplements (only once a day)\n* No blood donations during the study.\n* Reported intense sporting activities less than 10h/w\n* Reported alcohol consumption less than 21 units/w (female volunteers) or less than 28 units/w (male volunteers)\n* Having a General Practitioner\n* Informed consent signed\n* Recruitment form filled out\n\nExclusion Criteria:\n\n* Smoking\n* Dislike, allergy/intolerance or not known with the foods of the ad libitum meal\n* Possible eating disorder (measured by SCOFF questionnaire)\n* High or very high restrained eaters (measured by questionnaire) (men with BMI \\< 27: restraint score \\> 2.37, men with BMI less than 27: restraint score \\> 3.04, women with BMI \\< 26: restraint score \\> 3.24, women with BMI less than 26: restraint score \\> 3.41)\n* Reported medical treatment that may affect eating habits/satiety\n* Reported intolerance or allergy to test products\n* Women reported lactating (or lactating \\< 6 weeks ago), pregnant (or pregnant \\< 3 months ago) or wish to become pregnant during the study\n* Reported weight loss/gain (10%) in the last six month before the trial\n* Reported participation in another biomedical trial 1 month before the start of the study\n* Reported working on late turns -'}, 'identificationModule': {'nctId': 'NCT00776256', 'briefTitle': 'Effects of Oligofructose and Barley on Satiety and Energy Intake', 'organization': {'class': 'INDUSTRY', 'fullName': 'Unilever R&D'}, 'officialTitle': 'The Effect of Meal Replacement Bars Containing Different Types of Fibres (Oligofructose and/or Barley) on Satiety and Energy Intake', 'orgStudyIdInfo': {'id': '07002V'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'effect of beta-glucan', 'interventionNames': ['Dietary Supplement: beta-glucan and fructooligosaccharide']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'effect of fructo-oligosaccharide', 'interventionNames': ['Dietary Supplement: beta-glucan and fructooligosaccharide']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'effect of beta-glucan and fructooligosaccharide', 'interventionNames': ['Dietary Supplement: beta-glucan and fructooligosaccharide']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'description': 'no beta-glucan nor fructooligosaccharide', 'interventionNames': ['Dietary Supplement: beta-glucan and fructooligosaccharide']}], 'interventions': [{'name': 'beta-glucan and fructooligosaccharide', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['oats', 'barley', 'oligofructose'], 'description': '1g beta-glucan or 8 g fructooligosaccharide or combination per meal replacement bar given twice on day 1 and once on day 2', 'armGroupLabels': ['1', '2', '3', '4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3133AT', 'city': 'Vlaardingen', 'country': 'Netherlands', 'facility': 'Unilever R&D Vlaardingen', 'geoPoint': {'lat': 51.9125, 'lon': 4.34167}}], 'overallOfficials': [{'name': 'Edward Haddeman', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Unilever R&D'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unilever R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Harry Peters', 'oldOrganization': 'Unilever R&D'}}}}