Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2026-02-27 @ 9:48 PM
Study NCT ID:
NCT05417659
Status:
COMPLETED
Last Update Posted:
2025-03-27
First Post:
2022-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycogen and Appetite
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D009525', 'term': 'Niacin'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2022-05-17', 'studyFirstSubmitQcDate': '2022-06-12', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in plasma GLP-1 concentrations post exercise', 'timeFrame': '2 hours', 'description': 'Incremental area under the curve of plasma GLP-1 concentrations'}, {'measure': 'Change in plasma leptin concentrations post exercise', 'timeFrame': '2 hours', 'description': 'Incremental area under the curve of plasma leptin concentrations'}, {'measure': 'Change in plasma insulin concentrations during exercise', 'timeFrame': '1 hour', 'description': 'Incremental area under the curve for plasma insulin concentrations'}, {'measure': 'Change in plasma non-esterified fatty acid concentrations during exercise', 'timeFrame': '1 hour', 'description': 'Incremental area under the curve for plasma non-esterified fatty acid concentrations'}, {'measure': 'Change in plasma glucose concentrations during exercise', 'timeFrame': '1 hour', 'description': 'Incremental area under the curve for plasma glucose concentrations'}, {'measure': 'Change in plasma lactate concentrations during exercise', 'timeFrame': '1 hour', 'description': 'Incremental area under the curve for plasma lactate concentrations'}, {'measure': 'Change in carbohydrate oxidation during exercise', 'timeFrame': '1 hour', 'description': 'Incremental area under the curve for carbohydrate oxidation'}, {'measure': 'Change in fat oxidation during exercise', 'timeFrame': '1 hour', 'description': 'Incremental area under the curve for fat oxidation'}, {'measure': 'Change in skin temperature during exercise', 'timeFrame': '1 hour', 'description': 'Incremental area under the curve for skin temperature'}, {'measure': 'Change in core body temperature during exercise', 'timeFrame': '1 hour', 'description': 'Incremental area under the curve for core body temperature'}, {'measure': 'Muscle glycogen utilisation', 'timeFrame': '1 hour', 'description': 'Difference in muscle glycogen utilisation during exercise between conditions'}, {'measure': 'Extra-muscular glycogen oxidation', 'timeFrame': '1 hour', 'description': 'Difference in extra muscular glycogen oxidation during exercise between conditions'}, {'measure': 'Difference in blood pressure between conditions', 'timeFrame': '3 hours', 'description': 'Difference in blood pressure between conditions'}], 'primaryOutcomes': [{'measure': 'Difference in ad libitum energy intake', 'timeFrame': '2 hours post exercise', 'description': 'Difference between ad libitum energy intake (kcal) post exercise between trials'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Energy Intake']}, 'descriptionModule': {'briefSummary': 'Obesity is the outcome of chronic excessive energy intake and reduced energy expenditure leading to energy imbalance. It is a risk factor for many preventable diseases such as metabolic disease and its consequences such as type 2 diabetes and cardiovascular disease. Sedentary adults have been shown to have an increased appetite in excess of energy requirements and adults who are more active are able to better regulate energy intake. It is thought that carbohydrate availability and specifically hepatic glycogen utilisation during exercise is a regulator of appetite. However, the majority of research so far does not support this theory, potentially due to research not examining the tissue-specific link between glycogen use and appetite. The aim of this study is to assess whether altering substrate utilisation during exercise by suppressing lipolysis influences GLP-1 levels and caloric intake post exercise. Additionally, the study will explore if there is a tissue specific link between substrate utilisation and post exercise energy intake and examine potential sex differences.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males aged 18-60 and premenopausal women\n* Physically active (at least 30 minutes of exercise 3 times a week)\n* Body mass index 18.0-30.0 kg·m-2\n\nExclusion Criteria:\n\n* Weight instability (\\>5kg change in body mass over last 6 months)\n* Restrained eater (e.g. limiting food intake, calorie counting)\n* Current smoker\n* Aversion or allergy to test meal foods\n* Pregnant or lactating\n* Amenorrhoea in women\n* Any medical condition or medication that could introduce bias into the study (e.g., diabetes, CVD, lipid or glucose metabolism altering medications)\n* Any cardiopulmonary condition prohibiting exercise testing\n* Any contraindication to niacin or aspirin (e.g., diabetes, gout, clotting disorders, allergy to non-steroidal anti-inflammatory drugs)'}, 'identificationModule': {'nctId': 'NCT05417659', 'briefTitle': 'Glycogen and Appetite', 'organization': {'class': 'OTHER', 'fullName': 'University of Bath'}, 'officialTitle': 'The Effect of Suppression of Adipose Lipolysis on GLP-1 and Energy Intake in Men and Women', 'orgStudyIdInfo': {'id': 'EIRA1-7142'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'A placebo drink to be consumed 1 hour prior to exercise and every 15 minutes during exercise and placebo tablets to be consumed 30 minutes prior to exercise, at the onset of exercise and 30 minutes into exercise.', 'interventionNames': ['Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise plus carbohydrate', 'description': 'A high carbohydrate drink (1.6g/kg) to be consumed 1 hour prior to exercise and further drinks (0.2g/kg) every 15 minutes during exercise.', 'interventionNames': ['Dietary Supplement: Exercise plus carbohydrate']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise plus niacin', 'description': 'A dose of niacin (10mg/kg) to be consumed 30 minutes prior to exercise and two further doses (5mg/kg) at the onset of exercise and 30 minutes into exercise.', 'interventionNames': ['Dietary Supplement: Exercise plus niacin']}], 'interventions': [{'name': 'Exercise plus carbohydrate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A high carbohydrate drink to be consumed 1 hour prior to exercise and every 15 minutes during exercise.', 'armGroupLabels': ['Exercise plus carbohydrate']}, {'name': 'Exercise plus niacin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A dose of niacin to be consumed 30 minutes prior to exercise, at onset of exercise and 30 minutes into exercise.', 'armGroupLabels': ['Exercise plus niacin']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'A placebo drink to be consumed 1 hour prior to exercise and every 15 minutes during exercise and placebo tablets to be consumed 30 minutes prior to exercise, at the onset of exercise and 30 minutes into exercise.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BA2 7AY', 'city': 'Bath', 'country': 'United Kingdom', 'facility': 'Department for Health, University of Bath', 'geoPoint': {'lat': 51.3751, 'lon': -2.36172}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bath', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Student', 'investigatorFullName': 'Louise Bradshaw', 'investigatorAffiliation': 'University of Bath'}}}}