Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-24 @ 4:45 PM
Study NCT ID:
NCT04000750
Status:
COMPLETED
Last Update Posted:
2023-02-09
First Post:
2019-06-25
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Time-Restricted Eating and Muscle Hypertrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006984', 'term': 'Hypertrophy'}, {'id': 'D000093763', 'term': 'Intermittent Fasting'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005215', 'term': 'Fasting'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}, {'id': 'D000067816', 'term': 'Whey Proteins'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D008894', 'term': 'Milk Proteins'}, {'id': 'D000080224', 'term': 'Animal Proteins, Dietary'}, {'id': 'D004044', 'term': 'Dietary Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000067796', 'term': 'Whey'}, {'id': 'D008892', 'term': 'Milk'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants will know their group. Training and Nutrition research team members will know the participants group. Data analysis team will be blinded to condition.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-02-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-08', 'studyFirstSubmitDate': '2019-06-25', 'studyFirstSubmitQcDate': '2019-06-26', 'lastUpdatePostDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Muscle Size - Lower Body', 'timeFrame': 'Pre, Mid (4 weeks), and Post (8 weeks)', 'description': 'via Ultrasound'}, {'measure': 'Changes in Muscle Size - Upper Body', 'timeFrame': 'Pre, Mid (4 weeks), and Post (8 weeks)', 'description': 'via Ultrasound'}, {'measure': 'Changes in Fiber Type-Specific Size', 'timeFrame': 'Pre and Post (week 8)', 'description': 'Single muscle fiber analysis'}, {'measure': 'Changes in Body composition', 'timeFrame': 'Pre, Mid (4 weeks), and Post (8 weeks)', 'description': 'via BodPod'}, {'measure': 'Acute Exercise Induced Fiber Type-Specific Anabolic Signaling (Total Concentration and Phosphorylation Status)', 'timeFrame': 'Day 1 of exercise training', 'description': 'Men only; assessed via single fiber Simple Western'}], 'secondaryOutcomes': [{'measure': 'Changes in Maximal Strength', 'timeFrame': 'Pre and Post (week 8)', 'description': '1RM on bench press, squat, and leg extension'}, {'measure': 'Changes in Maximal Muscular Endurance', 'timeFrame': 'Pre and Post (week 8)', 'description': 'Maximal repetitions on bench press and leg press'}, {'measure': 'Changes in Gut Microbiome', 'timeFrame': 'Pre, Mid (week 2, 4, 6), and Post (week 8)', 'description': 'via stool sample'}, {'measure': 'Changes in Fiber Type Composition', 'timeFrame': 'Pre and Post (week 8)', 'description': 'Single Fiber via SDS-PAGE'}, {'measure': 'Changes in Fiber Type-Specific Resting Anabolic Signaling (Total Concentration and Phosphorylation Status)', 'timeFrame': 'Pre and Post (week 8)', 'description': 'via single fiber Simple Western'}, {'measure': 'Changes in Mood', 'timeFrame': 'Weekly for duration of the intervention (8 weeks)', 'description': 'via Questionnaire'}, {'measure': 'Changes in Enjoyment of Diet', 'timeFrame': 'Weekly for duration of the intervention (8 weeks)', 'description': 'via Questionnaire'}, {'measure': 'Changes in Sleep (total and quality)', 'timeFrame': 'Weekly for duration of the intervention (8 weeks)', 'description': 'via Questionnaire'}, {'measure': 'Changes in Menstrual Cycle', 'timeFrame': 'Pre, Mid (week 4), and post (week 8)', 'description': 'via Questionnaire; women only'}, {'measure': 'Total Training Volume', 'timeFrame': 'After 8 weeks'}, {'measure': 'Nutrient Intake', 'timeFrame': 'Daily, starting 7 days before the study and continuing for 8 additional weeks', 'description': 'Total Kcal and grams of protein, fat, and carbohydrates'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypertrophy', 'Intermittent Fasting', 'Time Restricted Eating', 'Protein Signaling', 'Anabolic'], 'conditions': ['Muscle Hypertrophy', 'Healthy and Well-Trained Men and Women']}, 'descriptionModule': {'briefSummary': 'The purpose is to examine the effects of time-restricted eating (TRE; consuming all calories within an 8-hour period each day) vs. normal eating (CON; consuming same kcals and protein as TRE, but during a 10-13 hr eating window each day) during 8 weeks of resistance exercise on body composition and muscle mass (whole muscle and single fiber), muscular performance, anabolic protein signaling, single muscle fiber characteristics, and the gut microbiome in well-trained young men and women.', 'detailedDescription': 'The primary goal pertains to muscle hypertrophy (not fat loss), thus all participants will be placed in a 10% caloric surplus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-35 years old with \\<25% (men) or \\<30% (women) body fat\n* have experience in resistance exercise for the whole body and performed resistance exercise at least 3 times per week the last 12 months\n* be able to perform all necessary exercises with safe technique and no pain\n* be able to squat 1.5x (men) or 1x (women) body weight\n* be able to bench press 1.1x (men) or 0.55x (women) body weight\n* be on a non-specialized, mixed macronutrient diet\n* have a lifestyle which enables a reasonably consistent 7+ hours of sleep per night\n* be free of any current joint, musculoskeletal, and/or neuromuscular injuries\n\nExclusion Criteria:\n\n* have any known current illness, prohibitive muscular or neuromuscular problem, hypertension, cardiac, pulmonary, liver, kidney, insulin or any other metabolic disorders (e.g. Type I or Type II diabetes)\n* are lactose intolerant or unable to consume whey protein for any reason\n* are on any medications known to affect protein metabolism\n* have taken antibiotics in the last 6 months\n* cannot refrain from consuming any alcoholic beverages, nicotine, or marijuana (or derivative) for a period of 48 hours prior to data collection (pre and post testing)\n* consume alcohol \\>2x per week\n* consume any analgesic or anti-inflammatory drug(s), prescription or non-prescription, chronically or within 48 hours of data collection\n* consume any recreational drug(s), prescription or non-prescription, legal or illegal, chronically or within 30 days of data collection\n* consume any caffeine or food within 12 hours of data collection\n* cannot refrain from physical exercise (outside of activities of daily living) outside of what is prescribed by the research team for the duration of the study\n* cannot refrain from using recovery methods such as electric stimulation, hot/cold therapy, massage, chiropractic, or personal air/water devices (Normatech, etc.)\n* have utilized any anabolic steroid, currently or in the past\n* cannot refrain from consumption of any supplementation (creatine, multivitamin, fish oil, protein powder, BCAA, pre-workouts, etc.) outside of what is provided\n* cannot refrain from consuming any supplemental pro or prebiotics or other items that intentionally alter the gut microbiome\n* fail to adhere to the nutritional guidelines or miss \\>3 of the exercise sessions\n* were recently pregnant, trying to become pregnant, or are currently breastfeeding'}, 'identificationModule': {'nctId': 'NCT04000750', 'briefTitle': 'Time-Restricted Eating and Muscle Hypertrophy', 'organization': {'class': 'OTHER', 'fullName': 'California State University, Fullerton'}, 'officialTitle': 'The Influence of 16:8 Time-Restricted Eating on Resistance Exercise-Induced Skeletal Muscle Hypertrophy', 'orgStudyIdInfo': {'id': 'CSP Fullerton'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Time Restricted Eating (16:8)', 'description': 'Participants will consume all calories within an 8 hour window each day.', 'interventionNames': ['Other: Time Restricted Eating', 'Other: Resistance Training', 'Dietary Supplement: Whey Protein']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Participants will consume all calories within a \\~12 hour window each day (4 separate meals + needed snacks).', 'interventionNames': ['Other: Normal Feeding', 'Other: Resistance Training', 'Dietary Supplement: Whey Protein']}], 'interventions': [{'name': 'Time Restricted Eating', 'type': 'OTHER', 'description': 'Diet will be tracked and reported every day to a qualified dietitian.', 'armGroupLabels': ['Time Restricted Eating (16:8)']}, {'name': 'Normal Feeding', 'type': 'OTHER', 'description': 'Diet will be tracked and reported every day to a qualified dietitian.', 'armGroupLabels': ['Control']}, {'name': 'Resistance Training', 'type': 'OTHER', 'description': '8 weeks of supervised and programmed whole body resistance training, performed 4x per week', 'armGroupLabels': ['Control', 'Time Restricted Eating (16:8)']}, {'name': 'Whey Protein', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Consumed on all exercise days.', 'armGroupLabels': ['Control', 'Time Restricted Eating (16:8)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92831', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Center for Sport Performance at California State University, Fullerton', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'California State University, Fullerton', 'class': 'OTHER'}, 'collaborators': [{'name': 'San Francisco State University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Andrew Galpin', 'investigatorAffiliation': 'California State University, Fullerton'}}}}