Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-29 @ 6:58 PM
Study NCT ID:
NCT05017259
Status:
COMPLETED
Last Update Posted:
2021-08-23
First Post:
2021-08-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Calorie Restriction Diets on Weight Reduction, Post weigh-in Recovery and Exercise Performance in Athletes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D031204', 'term': 'Caloric Restriction'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D002149', 'term': 'Energy Intake'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-17', 'studyFirstSubmitDate': '2021-08-15', 'studyFirstSubmitQcDate': '2021-08-17', 'lastUpdatePostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body weight in kilograms assessed by air-displacement plethysmography (Bod Pod)', 'timeFrame': '1 min', 'description': 'The body weight (kg) of participants was determined before and after calorie restriction intervention to evaluate the degree of weight loss.'}, {'measure': 'Body fat mass in kilograms assessed by air-displacement plethysmography (Bod Pod)', 'timeFrame': '1 min', 'description': 'The body fat mass (kg) of participants was determined before and after calorie restriction intervention to evaluate the degree of weight loss.'}, {'measure': 'Lean body mass in kilograms assessed by air-displacement plethysmography (Bod Pod)', 'timeFrame': '1 min', 'description': 'The lean body fat mass (kg) of participants was determined before and after calorie restriction intervention to evaluate the degree of weight loss.'}], 'secondaryOutcomes': [{'measure': 'Taekwondo-specific reaction time in seconds assessed by Electromyography (EMG) signals', 'timeFrame': '1 min', 'description': 'The reaction time (sec) was measured before and after weight loss to assess the difference in exercise performance. The participants were asked to make the fist on the left hand as soon as they see a light signal, then start the taekwondo-specific movement. The reaction time was calculated as the time from the beginning of the light signal to the start of electromyography (EMG) signal of the left thenar muscles. The movement was performed 5 times. The average reaction time was used to arrive at one reported value.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diet, Reducing']}, 'descriptionModule': {'briefSummary': 'Low-carbohydrate diets are often used as weight-loss strategies by obese individuals and athletes. This diet has effects on oxidizing fat and suppressing appetite. But short term evidences are still few. In combat sports such as taekwondo, athletes prefer rapid weight loss to achieve a desired weight category. The purpose of this study was to investigate the impact of the low carbohydrate diet combined with strict calorie restriction on body composition and exercise performance in taekwondo athletes.', 'detailedDescription': 'This study used a randomized cross-over design. Each participant completed a low carbohydrate and a high carbohydrate trial in a random order, separated by a 30-day wash-out period. Each trial comprised of a 7-day weight loss period, followed by an 18-hr recovery period. The purpose of this study was to investigate the effect of 7-day caloric restriction with low- or high-carbohydrate diet, combined with an 18-hr recovery period, on body weight loss and taekwondo-specific performance.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '24 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have at least 6 years of Taekwondo training experience\n* Must have participated in domestic or international competitions\n\nExclusion Criteria:\n\n* Smoking\n* Cardiovascular disease\n* Diabetes\n* Hypertension\n* Any medication in the past 3 months'}, 'identificationModule': {'nctId': 'NCT05017259', 'briefTitle': 'Calorie Restriction Diets on Weight Reduction, Post weigh-in Recovery and Exercise Performance in Athletes', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan Sport University'}, 'officialTitle': 'The Metabolomic Exploration of Low-carbohydrate and Calorie Restriction Diet on Weight Reduction, Post weigh-in Recovery and Exercise Performance in Taekwondo Athletes', 'orgStudyIdInfo': {'id': 'MOST 108-2410-H-028-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low carbohydrate trial', 'description': 'The energy distribution was carbohydrate 10%, protein 40-50%, fat 40-50% in the LC trial.', 'interventionNames': ['Dietary Supplement: calorie restriction diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'high carbohydrate trial', 'description': 'The energy distribution was carbohydrate 60-65%, protein 30-40%, fat 5-10% in the HC trial.', 'interventionNames': ['Dietary Supplement: calorie restriction diet']}], 'interventions': [{'name': 'calorie restriction diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The 7-day low-calorie diet contained 15.8 ± 0.4 kcal/kg/d in both trials, divided into three meals a day.', 'armGroupLabels': ['high carbohydrate trial', 'low carbohydrate trial']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taichung', 'country': 'Taiwan', 'facility': 'National Taiwan University of Sport', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'Chin Hsu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chin Hsu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Chin Hsu', 'investigatorAffiliation': 'National Taiwan Sport University'}}}}