Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-02-20 @ 12:34 PM
Study NCT ID:
NCT05439720
Status:
UNKNOWN
Last Update Posted:
2022-06-30
First Post:
2022-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Effect of Exogenous Ketosis on Sleep Architecture Following Strenuous Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007662', 'term': 'Ketosis'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C524675', 'term': 'formic acid 4-(3-oxobutyl)phenyl ester'}, {'id': 'D015444', 'term': 'Exercise'}], '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-28', 'studyFirstSubmitDate': '2022-06-16', 'studyFirstSubmitQcDate': '2022-06-28', 'lastUpdatePostDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total sleep time', 'timeFrame': 'Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)', 'description': 'Change in total sleep time between conditions as evaluated with polysomnography'}, {'measure': 'Urinary nocturnal adrenaline excretion', 'timeFrame': 'Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)', 'description': 'Change in urinary nocturnal adrenaline excretion between conditions'}, {'measure': 'Urinary nocturnal noradrenaline excretion', 'timeFrame': 'Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)', 'description': 'Change in urinary nocturnal adrenaline excretion between conditions'}], 'secondaryOutcomes': [{'measure': 'Total rapid-eye-movement sleep', 'timeFrame': 'Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)', 'description': 'Change in total rapid-eye-movement sleep between conditions as evaluated with polysomnography'}, {'measure': 'Total non-rapid-eye-movement sleep', 'timeFrame': 'Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)', 'description': 'Change in total non-rapid-eye-movement sleep between conditions as evaluated with polysomnography'}, {'measure': 'Total slow-wave sleep', 'timeFrame': 'Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)', 'description': 'Change in total slow-wave sleep between conditions as evaluated with polysomnography'}, {'measure': 'Plasma adrenaline concentration', 'timeFrame': 'Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)', 'description': 'Change in plasma adrenaline concentration between conditions'}, {'measure': 'Plasma noradrenaline concentration', 'timeFrame': 'Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)', 'description': 'Change in plasma noradrenaline concentration between conditions'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ketone', 'Exercise', 'Sleep'], 'conditions': ['Sleep']}, 'referencesModule': {'references': [{'pmid': '37259248', 'type': 'DERIVED', 'citation': 'Robberechts R, Albouy G, Hespel P, Poffe C. Exogenous Ketosis Improves Sleep Efficiency and Counteracts the Decline in REM Sleep after Strenuous Exercise. Med Sci Sports Exerc. 2023 Nov 1;55(11):2064-2074. doi: 10.1249/MSS.0000000000003231. Epub 2023 Jun 1.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effect of oral ketone ester administration on sleep architecture. To investigate this, the investigators use a randomised, placebo-controlled, cross-over research design. The study comprises three experimental sessions, each separated by a one-week washout period. Two of the three experimental sessions consist of a 120 minutes cycling endurance training session (ET) two hours after breakfast and an evening high-intensity-interval training (HIIT) ending one hour before bedtime. After each training session, and 30 minutes before sleeptime, subjects receive a ketone ester or a control drink . To investigate the effects of strenuous exercise on sleep alone, an additional experimental session without exercise is added.\n\nBefore bedtime, a venous blood sample is taken to evaluate hormones playing an important role in sleep regulation. During the experimental sessions, the subjects sleep in a sleep facility to evaluate quality of sleep. Time spent in different sleep phases is measured via polysomnography (PSG). Urine output throughout the day and night will be collected for measurement of urinary excretion of adrenaline and noradrenaline as an index of intrinsic sympathetic activity.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males between 18 and 35 years old\n* Recreational or competitive cyclists performing regularly cycling training sessions with an average training volume of more than 6 hours per week\n* Good health status confirmed by a medical screening\n* Body Mass Index (BMI) between 18 and 25\n* Normal sleep pattern as assessed by the Pittsburgh Sleep Quality Index (PSQI)\n* Moderate sleep chronotype, assessed by the Horne and Östberg questionnaire\n\nExclusion Criteria:\n\n* Excessive daytime sleepiness as assessed by the Epworth scale\n* Depression or anxiety as assessed by the Beck Depression Inventory and Beck Anxiety Inventory\n* Night-shifts or travel across time zones in the month preceding the study\n* Any kind of injury/pathology that is a contra-indication to perform high-intensity exercise\n* Intake of any medication or nutritional supplement that is known to affect exercise performance or sleep\n* Smoking\n* Involvement in elite athletic training at a semi-professional or professional level\n* Current participation in another research trial\n* Any other argument to believe that the subject is unlikely to successfully complete the full study protocol'}, 'identificationModule': {'nctId': 'NCT05439720', 'briefTitle': 'Acute Effect of Exogenous Ketosis on Sleep Architecture Following Strenuous Exercise', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'Acute Effect of Exogenous Ketosis on Sleep Architecture Following Morning and Evening Strenuous Exercise', 'orgStudyIdInfo': {'id': 'S65394'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise and ketone', 'description': 'Ketone ester is provided', 'interventionNames': ['Dietary Supplement: Ketone ester', 'Behavioral: Exercise']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Exercise and placebo', 'description': 'Placebo is provided', 'interventionNames': ['Dietary Supplement: Placebo', 'Behavioral: Exercise']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Non-exercise and placebo', 'description': 'Placebo is provided', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Ketone ester', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A dose of 25g of ketone ester after each training session and 30 minutes before sleeptime. The total dose is 75g of ketone ester.', 'armGroupLabels': ['Exercise and ketone']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Collagen peptan (3g) mixed with 1 mM bitter sucrose octaacetate and 20ml of pure water. A dose of 25g of placebo drink is provided after each training session and 30 minutes before sleeptime. The total dose is 75g of placebo drink.', 'armGroupLabels': ['Exercise and placebo', 'Non-exercise and placebo']}, {'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': 'A 120 minutes cycling endurance training session (ET) two hours after breakfast and an evening high-intensity-interval training (HIIT) ending one hour before bedtime', 'armGroupLabels': ['Exercise and ketone', 'Exercise and placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Exercise Physiology Group', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Peter Hespel', 'investigatorAffiliation': 'KU Leuven'}}}}