Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT06962605
Status:
RECRUITING
Last Update Posted:
2025-05-08
First Post:
2025-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Intermittent Running on Metabolic Health
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': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Participants will be asked to perform 4 trials in a randomized-crossover design (1) moderate-intensity continuous running (MICE: 60% V̇O2max), (2) 5-minute interval running (5MIN; 50% and 70% V̇O2max), (3) 2-minute interval running (2MIN; 50% and 70% V̇O2max), or (4) a control with no exercise (CON).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2025-04-22', 'studyFirstSubmitQcDate': '2025-04-29', 'lastUpdatePostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucose concentrations', 'timeFrame': '120 minutes', 'description': 'Changes in blood glucose responses during OGTT test.'}, {'measure': 'Insulin concentrations', 'timeFrame': '120 minutes', 'description': 'Changes in blood insulin responses during OGTT test.'}], 'secondaryOutcomes': [{'measure': 'Total energy expenditure', 'timeFrame': '190 minutes', 'description': 'Changes in total energy expenditure during 40-minutes running, 30 minutes of EPOC and 120 minutes of OGTT'}, {'measure': 'Substrate utilisation', 'timeFrame': '190 minutes', 'description': 'Changes in total energy expenditure during 40-minutes running, 30 minutes of EPOC and 120 minutes of OGTT'}, {'measure': 'Gut hormone responses', 'timeFrame': '190 minutes', 'description': 'Changes in gut hormone responses (e.g., GLP-1 and PYY) during trials'}, {'measure': 'Muscle oxygen saturation', 'timeFrame': '70 minutes', 'description': 'Changes in muscle oxygen during 40 minutes running and 30 minutes EPOC'}, {'measure': 'Subjective appetite sensation', 'timeFrame': '190 minutes', 'description': 'Changes in subjective feeling of appetite using 0-100 mm scale (e.g., hunger and satisfaction) during trials'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intermittent running', 'OGTT', 'Energy expenditure', 'Glucose control'], 'conditions': ['Glucose Control', 'Metabolic Regulation', 'Energy Expenditure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the suitability of intermittent exercise of long and short intervals at lower intensities than HIIE on energy expenditure during and post-exercise compared to MICE, as well as determine whether similar or greater effects can be achieved for glycemic control in recreationally active adults.', 'detailedDescription': 'The same procedure will be repeated for all trials: Participants will be asked to perform 4 trials in a randomized-crossover design \\[moderate-intensity continuous running (MICE: 60% V̇O2max), 5-minute interval running (5MIN; 50% and 70% V̇O2max), 2-minute interval running (2MIN; 50% and 70% V̇O2max), or a control with no exercise (CON)\\]. All trials will be separated by at least 4 days wash-out and less than 14 days between trials to ensure complete rest.\n\nSensors for measuring muscle oxygen (10 cm proximal to the mid-patella, and 2 cm lateral) will be placed on the rectus femoris muscle and 15 min resting metabolic rate was measured. A bilateral antecubital venous line for blood sampling will be inserted by a nurse. After baseline measurements, participants warm-up for 3 minutes with fixed walking intensity (i.e., 5 km/h) followed by 40 minutes running. Immediately after the running, participants return to a seated position for 30 minutes post-exercise measurements (EPOC). After the 30 minutes measurement, 5-minutes was given for participants to go to the bathroom and drink 100ml water, whereafter a standard 120-minutes oral glucose tolerance test (OGTT) is conducted (75g glucose dose with 50ml of water). The timer will be started at the first sip.\n\nDuring the EPOC and resting metabolic rate (RMR) measurement participants will sit in a comfortable position and need to limit fidgeting, thus allowed only to watch TV or videos on their phone. During the OGTT, participants can do any calm activity such as watching TV, reading, working on the laptop, but no physical activity. Participants will be wheeled to the bathroom if needed.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy recreationally active men\n* BMI between 18.5-27 kg/m2\n* Aged between 20 to 45 years\n* Regular exercise (3 times per week and longer than 3 months) with cardio exercise longer than 30 minutes at least once a week\n* Weight stable for more than 3 months (no change in weight +/- 3%)\n* Non-shift workers and sleep at least 6.5-9 hours for the past 3 months\n* Non-smoker\n\nExclusion Criteria:\n\n* having any cardiovascular, metabolic or pulmonary disease (angina pectoris or uncontrolled arrhythmias)\n* suffering from infectious contagious diseases,\n* using medications that could affect metabolic responses (including anti-inflammatory medications)\n* smoking\n* heavy alcohol intake (more than 4 drinks on any day or more than 14 drinks a week).\n* undergoing special diets (e.g., intermittent fasting and/or ketogenic diets)'}, 'identificationModule': {'nctId': 'NCT06962605', 'briefTitle': 'Effects of Intermittent Running on Metabolic Health', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan Normal University'}, 'officialTitle': 'Acute Effects of Intermittent vs. Continuous Running Exercise on Physiological and Metabolic Responses', 'orgStudyIdInfo': {'id': '202502HM010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Moderate-intensity continuous running (MICE: 60% V̇O2max)', 'description': 'Exercise', 'interventionNames': ['Behavioral: Moderate-intensity continuous running (MICE: 60% V̇O2max)']}, {'type': 'EXPERIMENTAL', 'label': '5-minute interval running (5MIN)', 'description': 'Exercise', 'interventionNames': ['Behavioral: 5-minute interval running (5MIN)']}, {'type': 'EXPERIMENTAL', 'label': '2-minute interval running (2MIN)', 'description': 'Exercise', 'interventionNames': ['Behavioral: 2-minute interval running (2MIN)']}, {'type': 'EXPERIMENTAL', 'label': 'A control with no exercise (CON)', 'description': 'Non-exercise control', 'interventionNames': ['Behavioral: Resting control']}], 'interventions': [{'name': 'Moderate-intensity continuous running (MICE: 60% V̇O2max)', 'type': 'BEHAVIORAL', 'description': 'Participants run continuously for 40 minutes at moderate intensity (60-65% V̇O2max)', 'armGroupLabels': ['Moderate-intensity continuous running (MICE: 60% V̇O2max)']}, {'name': '5-minute interval running (5MIN)', 'type': 'BEHAVIORAL', 'description': 'Participants run for 40 minutes at average moderate intensity with 5-minutes slow and fast cycles where speed is increased and decreased by 20%.', 'armGroupLabels': ['5-minute interval running (5MIN)']}, {'name': '2-minute interval running (2MIN)', 'type': 'BEHAVIORAL', 'description': 'Participants run for 40 minutes at average moderate intensity with 2-minutes slow and fast cycles where speed is increased and decreased by 20%.', 'armGroupLabels': ['2-minute interval running (2MIN)']}, {'name': 'Resting control', 'type': 'BEHAVIORAL', 'description': 'Participants sit for 40 minutes in a comfortable position', 'armGroupLabels': ['A control with no exercise (CON)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'facility': 'National Taiwan Normal University', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Yung-Chih Chen, PhD', 'role': 'CONTACT', 'email': 'yc.chen@ntnu.edu.tw', 'phone': '+886277496979'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan Normal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yung-Chih Chen', 'investigatorAffiliation': 'National Taiwan Normal University'}}}}