Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2026-04-22 @ 7:47 PM
Study NCT ID:
NCT03310034
Status:
TERMINATED
Last Update Posted:
2020-08-20
First Post:
2017-10-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NAD Supplementation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized, dubbel-blind, cross-over trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'whyStopped': 'Concluded study following COVID19 outbreak and inability to complete study as designed.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-18', 'studyFirstSubmitDate': '2017-10-10', 'studyFirstSubmitQcDate': '2017-10-10', 'lastUpdatePostDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ex vivo mitochondrial respiration', 'timeFrame': 'After 4 weeks of supplementation.', 'description': 'Ex vivo mitochondrial function in skeletal muscle measured by oxygen consumption in muscle fibres (muscle biopsy vastus lateralis) on lipid-derived and carbohydrate-derived substrates.'}, {'measure': 'Basal metabolic rate', 'timeFrame': 'After 4 weeks of supplementation.', 'description': 'Basal metabolic rate expressed as kcal/kg/min'}, {'measure': 'In vivo mitochondrial capacity', 'timeFrame': 'After 4 weeks of supplementation.', 'description': 'In vivo mitochondrial capacity measured with 31P-MRS.'}, {'measure': 'Submaximal exercise energy expenditure', 'timeFrame': 'After 4 weeks of supplementation.', 'description': 'Submaximal exercise energy expenditure expressed as kcal/kg/min'}], 'secondaryOutcomes': [{'measure': 'Glucose tolerance', 'timeFrame': 'After 4 weeks of supplementation.', 'description': 'Glucose tolerance measured by oral glucose tolerance test.'}, {'measure': 'Ectopic lipid accumulation', 'timeFrame': 'After 4 weeks of supplementation.', 'description': 'Liver and skeletal muscle lipid accumulation measured with H-MRS in vivo.'}, {'measure': 'Acetylcarnitine levels', 'timeFrame': 'After 4 weeks of supplementation.', 'description': 'Skeletal muscle acetylcarnitine levels measured with H-MRS in vivo, before and after exercise stimulation (cycling).'}, {'measure': 'Physical function', 'timeFrame': 'After 4 weeks of supplementation.', 'description': 'Measured by Short Physical Performance Battery and Frailty criteria.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aging', 'Mitochondrial Function']}, 'referencesModule': {'references': [{'pmid': '34191033', 'type': 'DERIVED', 'citation': 'Connell NJ, Grevendonk L, Fealy CE, Moonen-Kornips E, Bruls YMH, Schrauwen-Hinderling VB, de Vogel J, Hageman R, Geurts J, Zapata-Perez R, Houtkooper RH, Havekes B, Hoeks J, Schrauwen P. NAD+-Precursor Supplementation With L-Tryptophan, Nicotinic Acid, and Nicotinamide Does Not Affect Mitochondrial Function or Skeletal Muscle Function in Physically Compromised Older Adults. J Nutr. 2021 Oct 1;151(10):2917-2931. doi: 10.1093/jn/nxab193.'}]}, 'descriptionModule': {'briefSummary': 'This research project aims to determine whether supplementing with a mixture of the NAD+-precursors NA, NAM, and tryptophan can stimulate skeletal muscle mitochondrial function in physically compromised, elderly humans. Outcomes are related to mitochondrial function, energy metabolism, and physical function will be investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males and females\n* Age ≥ 65 ≤ 75 years;\n* BMI ≥ 20 kg/m2 ≤ 30 kg/m2;\n* Normal physical activity levels: maximum of 1 hour per week engagement in a structured exercise session;\n* SPPB score 4-9 and (pre-)frail;\n* Subject should be in sufficient health to participate in the experiments, to be judged by the responsible physician based on the subject's medical history.\n\nExclusion Criteria:\n\n* Not meeting all inclusion criteria;\n* Smoking;\n* Excessive alcohol use and/or drug abuse;\n* Subjects with diabetes mellitus type 2;\n* Significant food allergies or intolerances concerning the study products;\n* Participation in another biomedical study within 1 month before the first study visit, possibly interfering with the study results;\n* Medication use known to hamper subject's safety during the study procedures;\n* Subjects who use selective serotonin re-uptake inhibitors (SSRI), or selective norepinephrin re-uptake inhibitors (SNRI), or monoamino oxidase inhibitors (MAO-inhibitors), or clomipramine, or St. John's wort (Hypericum perforatum);\n* Subjects with contra-indications for MRI;\n* Subjects who do not want to be informed about unexpected medical findings;\n* Subjects who do not want that their treating physician to be informed;\n* Co-morbidities to which the intervention or program the may pose as a complicating factor;\n* Inability to participate and/or complete the required measurements."}, 'identificationModule': {'nctId': 'NCT03310034', 'acronym': 'NADS', 'briefTitle': 'NAD Supplementation Study', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University'}, 'officialTitle': 'The Effects of NAD+-Precursor Supplementation on Energy Metabolism in Physically Compromised Elderly', 'orgStudyIdInfo': {'id': 'NL61204.068.17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'interventionNames': ['Dietary Supplement: NAD-precursors']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'interventionNames': ['Dietary Supplement: Control']}], 'interventions': [{'name': 'NAD-precursors', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Intervention product containing the NAD+-precursors nicotinic acid, nicotinamide, and tryptophan (total of 204 NE per serving) in a whey protein source for 31 days.', 'armGroupLabels': ['Intervention']}, {'name': 'Control', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Control product containing amino-acid mixture resembling whey-protein not containing the NAD+-precursors nicotinic acid, nicotinamide, and tryptophan. To be taken for 31 days.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6229ER', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Maastricht University', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. P. Schrauwen', 'investigatorFullName': 'Patrick Schrauwen', 'investigatorAffiliation': 'Maastricht University'}}}}