Ignite Creation Date:
2025-12-24 @ 5:15 PM
Ignite Modification Date:
2025-12-24 @ 5:15 PM
Study NCT ID:
NCT04016350
Status:
COMPLETED
Last Update Posted:
2019-07-11
First Post:
2019-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Exercise Combined With Inulin Propionate Ester on Fat Oxidation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'C000634130', 'term': 'inulin-propionate ester'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomised study with parallel design. Study participants underwent 4 week supervised moderate intensity exercise training combined either with IPE or cellulose as placebo supplementation at doses of 10g/day. Measurements were done before and after intervention'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2017-06-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-09', 'studyFirstSubmitDate': '2019-07-05', 'studyFirstSubmitQcDate': '2019-07-09', 'lastUpdatePostDateStruct': {'date': '2019-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resting fat oxidation', 'timeFrame': '4 weeks', 'description': 'Changes in resting fat oxidation measured in the fasted and postprandial states by means of indirect calorimetry (Oxycon Pro, Germany).'}, {'measure': 'Resting carbohydrate oxidation', 'timeFrame': '4 weeks', 'description': 'Changes in resting fat oxidation measured in the fasted and postprandial states by means of indirect calorimetry (Oxycon Pro, Germany).'}, {'measure': 'Metabolic rate', 'timeFrame': '4 weeks', 'description': 'Changes in resting energy expenditure measured in the fasted and postprandial states by means of indirect calorimetry (Oxycon Pro, Germany).'}], 'secondaryOutcomes': [{'measure': 'Body weight', 'timeFrame': '4 weeks', 'description': 'Changes in body weight measured by TANITA scales (TBF-300).'}, {'measure': 'Body fat (%)', 'timeFrame': '4 weeks', 'description': 'Changes in body fat expressed as percentage (proportion of fat to the total body weight) measured by TANITA scales (TBF-300).'}, {'measure': 'Maximal oxygen consumption [Time Frame: 4 weeks]', 'timeFrame': '4 weeks', 'description': 'Changes in maximal oxygen consumption (ml/kg/min) measured by Servomex Gas Analyser.'}, {'measure': 'Peptide YY (PYY)', 'timeFrame': '4 weeks', 'description': 'Changes in plasma concentration of fasting and postprandial PYY measured using ELISA (Merc Millipore) kit.'}, {'measure': 'Glucagon-like peptide-1 (GLP-1)', 'timeFrame': '4 weeks', 'description': 'Changes in plasma concentration of fasting and postprandial GLP-1 measured using ELISA (Merc Millipore) kit.'}, {'measure': 'Height', 'timeFrame': '4 weeks', 'description': 'Height (meters)measured by stadiometer, a vertical ruler with a sliding horizontal paddle which is adjusted to rest on the top of the head.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise,', 'Inulin Propionate Ester', 'Gut hormones', 'Body weigh', 'Fat oxidation', 'Overweight women'], 'conditions': ['Exercise', 'Inulin Propionate Ester']}, 'referencesModule': {'references': [{'pmid': '31790692', 'type': 'DERIVED', 'citation': 'Malkova D, Polyviou T, Rizou E, Gerasimidis K, Chambers ES, Preston T, Tedford MC, Frost G, Morrison DJ. Moderate intensity exercise training combined with inulin-propionate ester supplementation increases whole body resting fat oxidation in overweight women. Metabolism. 2020 Mar;104:154043. doi: 10.1016/j.metabol.2019.154043. Epub 2019 Nov 29.'}]}, 'descriptionModule': {'briefSummary': 'There is evidence to suggest that responsiveness to exercise training programmes can be expected to be influenced by changes in resting fat oxidation, an important factor in the aetiology of obesity. Our previous work has shown that oral supplementation with inulin propionate ester (IPE) reduces intra-abdominal fat and prevents weight gain and that oral propionate intake enhances resting fat oxidation. The effects of IPE combined with exercise training on resting fat oxidation and body fatness are unknown. The aim of this study was to investigate the impact of 4-weeks IPE supplementation, in combination with a moderate intensity exercise training programme, on whole body fat oxidation and on plasma GLP-1 and PYY.', 'detailedDescription': 'Participants: Healthy overweight females with BMI \\>25 kg/m2 and 25-45 years of age were recruited through advertisements and word of mouth on the campus of the University of Glasgow or from other public places. Participants were required to be sedentary, non-smokers, with stable body weight for two months prior to the study enrollment, not pregnant, free of medication, nutritional supplementation or following any specific diet and with no antibiotic use for the past three months. Participants with chronic illness, eating disorders and history of gastrointestinal operations were excluded.\n\nStudy Design: This is a randomized study with a parallel design. Study participants underwent 4 week supervised moderate intensity exercise training combined either with IPE (EX/IPE) or cellulose as placebo (EX/Placebo) supplementation at doses of 10g / day. Supplements were provided as sachets containing white powder and participants were asked to consume one sachet per day with breakfast in a way convenient for each participant. Before the start of the study and at the end of the 4-week intervention, participants were asked to conduct a submaximal exercise test. Prior to the first and after the second submaximal exercise test, participants of both groups conducted a 7-hour experimental trial which involved collection of expired air and blood samples in fasted and postprandial states. Body weight and body composition were measured in the fasted state. Prior to the first 7-hour experimental trial, participants were asked to record their diet for 3 days and replicate this intake prior to the second 7-hour experimental trial.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy, sedentary and overweight females with BMI \\>25 kg/m2 and stable body weight for two months prior to the study.\n\nExclusion Criteria:\n\nAcute or chronic illness, eating disorders, history of gastrointestinal operations, smoking, pregnancy, taking supplements, and being on specific diet for the past three months.'}, 'identificationModule': {'nctId': 'NCT04016350', 'acronym': 'IPE', 'briefTitle': 'Impact of Exercise Combined With Inulin Propionate Ester on Fat Oxidation', 'organization': {'class': 'OTHER', 'fullName': 'University of Glasgow'}, 'officialTitle': 'Impact of Moderate Intensity Exercise Training Combined With Inulin Propionate Ester Supplementation on Whole Body Resting Fat Oxidation and Body Weigh in Overweight Women', 'orgStudyIdInfo': {'id': 'UGlasgow IPE'}, 'secondaryIdInfos': [{'id': 'BB/L004259/1', 'type': 'OTHER_GRANT', 'domain': 'BBSRC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise Training with Inulin Propionate Ester', 'description': 'Study participants underwent 4 week supervised moderate intensity exercise training combined with Inulin Propionate Ester supplementation at doses of 10g / day.', 'interventionNames': ['Behavioral: Exercise training with Inulin Propionate Ester']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise Training with Placebo', 'description': 'Study participants underwent 4 week supervised moderate intensity exercise training combined with cellulose as placebo at doses of 10g / day.', 'interventionNames': ['Behavioral: Exercise training with placebo']}], 'interventions': [{'name': 'Exercise training with Inulin Propionate Ester', 'type': 'BEHAVIORAL', 'description': 'Supervised moderate intensity exercise training combined with Inulin Propionate Ester supplementation conducted for 4 weeks.', 'armGroupLabels': ['Exercise Training with Inulin Propionate Ester']}, {'name': 'Exercise training with placebo', 'type': 'BEHAVIORAL', 'description': 'Supervised moderate intensity exercise training combined with placebo conducted for 4 weeks', 'armGroupLabels': ['Exercise Training with Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Douglas Morrison, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Glasgow'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Glasgow', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Lecturer', 'investigatorFullName': 'Dr Dalia Malkova', 'investigatorAffiliation': 'University of Glasgow'}}}}