Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-27 @ 9:27 AM
Study NCT ID:
NCT00259259
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2005-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Lipids and Appetite Regulation
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C117372', 'term': 'salatrim'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'completionDateStruct': {'date': '2005-12'}, 'lastUpdateSubmitDate': '2009-01-20', 'studyFirstSubmitDate': '2005-11-28', 'studyFirstSubmitQcDate': '2005-11-28', 'lastUpdatePostDateStruct': {'date': '2009-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Appetite'}, {'measure': 'energy intake'}, {'measure': 'Hormones'}], 'secondaryOutcomes': [{'measure': 'Palability'}]}, 'conditionsModule': {'keywords': ['Appetite regulation', 'Hormones', 'Energy intake'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'To evaluate the short-term effects of structured lipids on appetite regulation.', 'detailedDescription': 'Background Obesity is a major health problem worldwide, and it is a risk factor for several chronic disorders. Even small changes in energy intake, leading to a positive balance may lead to weight gain over time. Thus, slight modifications in food intake, such as the inclusion of foods that effect energy balance, may prevent weight gain and even facilitate weight loss. Replacing dietary fat with low-calorie fat (LCF), such as modified triglycerides with medium and long chained PUFA.may be an efficient way to reduce body fat.\n\nBray et al. (2002) has shown a sustained weight loss of \\~6 kg over a 9 month period where one-third of a fat-reduced diet (25% fat) was replaced by olestra. This weight loss can not solely be explained by the decreased caloric content of olestra. Thus, inhibition of appetite leading to lower food intake, may be a potential mechanism of the observed weight loss.\n\nA reduced absorption of LCF leaves undigested fatty acids in the middle and lower intestine, which may generate increased feelings of satiety and decrease caloric intake due to regulating peptides and hormones such (CCK, GLP-1, etc.). In addition, intraduodenal fatty acids may also promote distension of the stomach and distension of the intestine, which are well-known gastrointestinal signals controlling mechanisms for food intake.\n\nTaken together, in addition to the acute reduction in caloric intake, LCF may encourage a gastrointestinal hormone response promoting beneficial effects on appetite regulation and energy balance.\n\nAims To evaluate the short-term effects of LCF on\n\nPrimary:\n\n* Appetite sensations after a meal (VAS)\n* Postprandiel secretion of appetite regulating hormones\n* Ad libitum caloric intake 4,5-h subsequent to a fixed meal\n\nSecondary:\n\n• Palatability of the test meal'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy males\n* Normal weigh, e.i. BMI between 18,5-25 kg/m2\n* age 18-40 years\n\nExclusion Criteria:\n\n* donation of blood 3 monhts prior or during the study\n* gastrointestinal disorders, diabetes, hypertension, hyperlipidemia, chronic infectious disease\n* smoking\n* consumption of more than 21 alcoholic drinks/week\n* elite athletes\n* on mediation\n* diet supplements'}, 'identificationModule': {'nctId': 'NCT00259259', 'briefTitle': 'Functional Lipids and Appetite Regulation', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'The Effect of Functional Lipids on Appetite Regulation in Man', 'orgStudyIdInfo': {'id': '(KF) 01 275625'}, 'secondaryIdInfos': [{'id': 'B218'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'SALATRIM', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1958', 'city': 'Frederiksberg C', 'state': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Human Nutrition, The Royal Veterinary and Agricultural University'}], 'overallOfficials': [{'name': 'Arne Astrup, Proffessor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of human nutrition, The Royal Veterinary and Agricultural University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Danisco', 'class': 'INDUSTRY'}]}}}