Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-29 @ 2:03 AM
Study NCT ID:
NCT00798668
Status:
COMPLETED
Last Update Posted:
2013-09-24
First Post:
2008-11-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Body's Response to Food Intake in Trained, Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-23', 'studyFirstSubmitDate': '2008-11-25', 'studyFirstSubmitQcDate': '2008-11-25', 'lastUpdatePostDateStruct': {'date': '2013-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantify the acute effects of fluid and solid foods on post-prandial (post-meal) appetite and food intake at the next eating occasion in trained and untrained, elderly people.', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Quantify the contribution of selected satiety factors (glucose, insulin, CCK, ghrelin, and GLP-1) and gastrointestinal transit time, to the differential appetitive responses to fluid versus solid foods in trained and untrained, elderly people', 'timeFrame': '6 weeks'}]}, 'conditionsModule': {'keywords': ['Endocrine and Gastrointestinal Response to Food'], 'conditions': ['Elderly']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to determine the effects of food supplements and strength training on appetite, the amount of energy expended, and body composition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll subjects must meet the following eligibility criteria:\n\n* Age range: 60 years and older\n* Body mass index between 20-29 kg/m2\n* Weight stable (\\< 2 kg weight change within last 6 months)\n* Non-smoking\n* Constant habitual activity patterns within last 3 months\n* Clinically normal blood profiles (specifically, normal liver and kidney function; normal complete blood count (non-anemic); fasting blood glucose \\<110 mg/dl)\n* Not taking medications known to influence appetite or metabolism\n* Non-diabetic\n* Confirmation of acceptability of eating the study test foods (solids and fluids)\n\nTrained subjects (Recruiting 36; N-25) must meet the following eligibility criteria:\n\n* Resistive exercise training (≥ 2 times a week) based on reported physical activity levels (questionnaire)\n* Active fitness level (≥ 2, 30-minute aerobic exercise sessions/week)\n\nSedentary subjects (Recruiting 36; N-25) must meet the following eligibility criteria:\n\n* Resistive exercise training (≤ 1 time a week) based on reported physical activity levels (questionnaire)\n* Active fitness level (≤ 2, 30-minute aerobic exercise sessions/week)\n\nExclusion Criteria:\n\nAll subjects will be excluded based on the following exclusionary criteria:\n\n* Age: \\<60 years\n* Body mass index: outside of the 20-29 kg/m2 range\n* Gained or lost \\> 4.5 kg within the last 6 months\n* Smoker (currently or within the last year)\n* Intermittently been involved in a diet and/or exercise program within the last 3 months\n* Clinically abnormal blood profiles as identified by our study physician, Arthur Rosen, MD\n* Taking medications (currently or within the last 3 months) known to influence appetite or metabolism\n* Abnormal heart function (interpreted by a cardiologist) and assessed (for study exclusion) by our study physician, Arthur Rosen, MD\n* Clinically diagnosed as diabetic\n* Study foods are found to be unacceptable for consumption by the subject\n* Clinically diagnosed osteoporosis\n\nTrained subjects will be excluded based on the following exclusionary criteria:\n\n* Did not perform resistive exercise training (currently or within the last 3 months) based on reported physical activity levels (questionnaire)\n* Perform ≤ 1, 30-minute aerobic exercise session/week (currently or within the last 3 months) based on physical activity levels questionnaire)\n\nSedentary subjects will be excluded based on the following exclusionary criteria:\n\n* Performed resistive exercise training (currently or within the last 3 months) based on reported physical activity levels (questionnaire)\n* Perform \\> 2, 30-minute aerobic exercise sessions/week (currently or within the last 3 months) based on physical activity levels questionnaire)'}, 'identificationModule': {'nctId': 'NCT00798668', 'briefTitle': "The Body's Response to Food Intake in Trained, Older Adults", 'organization': {'class': 'OTHER', 'fullName': 'Purdue University'}, 'orgStudyIdInfo': {'id': '0607004184'}, 'secondaryIdInfos': [{'id': 'NIH R01 AG021911-0102'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'participants continue current exercise and take liquid supplement', 'interventionNames': ['Dietary Supplement: Liquid Supplements']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Participants continue current exercise and take solid supplement', 'interventionNames': ['Dietary Supplement: Solid Supplement']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Participants continue current sedentary behavior and take liquid supplements', 'interventionNames': ['Dietary Supplement: Liquid Supplements']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'Participants continue current sedentary behavior and take solid supplements', 'interventionNames': ['Dietary Supplement: Solid Supplement']}], 'interventions': [{'name': 'Liquid Supplements', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Liquid supplement that provides 12.5% of the subjects total energy requirement.', 'armGroupLabels': ['1', '3']}, {'name': 'Solid Supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Solid supplement that provides 12.5% of the subjects total energy requirement.', 'armGroupLabels': ['2', '4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47907', 'city': 'West Lafayette', 'state': 'Indiana', 'country': 'United States', 'facility': 'Purdue University', 'geoPoint': {'lat': 40.42587, 'lon': -86.90807}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Purdue University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Foods and Nutrition', 'investigatorFullName': 'Wayne Campbell', 'investigatorAffiliation': 'Purdue University'}}}}