Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-30 @ 10:24 AM
Study NCT ID:
NCT01101633
Status:
COMPLETED
Last Update Posted:
2010-04-12
First Post:
2009-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Sodium Alginate on Appetite Sensation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000464', 'term': 'Alginates'}], 'ancestors': [{'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-04-09', 'studyFirstSubmitDate': '2009-08-25', 'studyFirstSubmitQcDate': '2010-04-09', 'lastUpdatePostDateStruct': {'date': '2010-04-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'appetite sensation', 'timeFrame': '5 hours'}], 'secondaryOutcomes': [{'measure': 'Plasma insulin and glucose level', 'timeFrame': '5 hours'}, {'measure': 'Well being and adverse events', 'timeFrame': '5 hours'}, {'measure': 'gastric emptying', 'timeFrame': '5 hours'}, {'measure': 'spontaneous calorie intake', 'timeFrame': '5 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Appetite', 'Energy intake', 'gastric emptying', 'well being', 'Body weight'], 'conditions': ['Obesity', 'Overweight']}, 'referencesModule': {'references': [{'pmid': '21779093', 'type': 'DERIVED', 'citation': 'Georg Jensen M, Kristensen M, Belza A, Knudsen JC, Astrup A. Acute effect of alginate-based preload on satiety feelings, energy intake, and gastric emptying rate in healthy subjects. Obesity (Silver Spring). 2012 Sep;20(9):1851-8. doi: 10.1038/oby.2011.232. Epub 2011 Jul 21.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate the effects of a low-calorie alginate containing fruit flavored beverage on appetite and body weight development.', 'detailedDescription': 'The project consists of two different studies:\n\nStudy I: A randomised controled meal test study aimed at studying the acute effect of the alginate-containing beverage on appetite sensation and spontaneous calorie intake (and safety i.e. nausea, well-being etc) in normal to overweight healthy subjects. Here, a placebo beverage or the alginate-containing beverage will be administered as a pre-load before a standardised breakfast meal. Subjective appetite sensation will be measured with Visual Analogue Scale (VAS) every 30 minutes four up to 5 hours. An additional beverage will be administered prior to an ad libitum lunch meal, where spontaneous water and energy intake will be registered.\n\nStudy II: Secondly the aim is to study the effects of a daily intake of a placebo or alginate-containing beverage on body weight and composition in a randomised parallel intervention study of 12 weeks duration. A total of app. 50 obese healthy adults will receive a hypocaloric diet and be randomised to consume either placebo or alginate-containing beverage before each of the three main meals every day. The development in body weight and composition and blood pressure will be monitored and blood samples will be analysed for markers related to the risk of CVD and type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men and women\n* Normal to slight overweight (BMI: 22-28 kg/m2)\n* 20-45 years of age\n\nExclusion Criteria:\n\n* Smoking\n* Daily medicine use (oral contraceptives excluded)\n* Use of dietary supplements\n* Blood donation 3 months prior to the study\n* Hb\\<7.5 mmol/l\n* Chronic illnesses such as hyperlipidemia, diabetes and inflammatory diseases\n* Pregnancy or breastfeeding\n* Elite athletes (\\>10 hours hard exercise/week)\n* Vegetarians'}, 'identificationModule': {'nctId': 'NCT01101633', 'acronym': 'B247Algobes', 'briefTitle': 'The Effect of Sodium Alginate on Appetite Sensation', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'The Effect of Sodium Alginate Containing Beverage on Appetite and Body Weight Regulation', 'orgStudyIdInfo': {'id': 'H-C-2008-088'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': '500 ml beverage containing alginate (3%)', 'interventionNames': ['Dietary Supplement: Alginate']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': '330 ml beverage containing alginate (3%)', 'interventionNames': ['Dietary Supplement: Alginate']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': '500 ml beverage without alginate (placebo)', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'description': '330 ml beverage without alginate (placebo)', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Alginate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'a 500 ml alginate beverage per meal test', 'armGroupLabels': ['1']}, {'name': 'Alginate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'a 330 ml alginate beverage per meal test', 'armGroupLabels': ['2']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'a 500 ml placebo beverage per meal test', 'armGroupLabels': ['3']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'a 330 ml placebo beverage per meal test', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1958', 'city': 'Frederiksberg', 'state': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Human Nutrtion, University of Copenhagen', 'geoPoint': {'lat': 55.67938, 'lon': 12.53463}}], 'overallOfficials': [{'name': 'Arne Astrup, Dr. Med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'SBiotek', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Arne Astrup, Prof. Dr. Med.', 'oldOrganization': 'Department of Human Nutrition'}}}}