Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-02-20 @ 10:08 PM
Study NCT ID:
NCT02850367
Status:
COMPLETED
Last Update Posted:
2021-09-29
First Post:
2016-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of NO Precursors on Physiological Responses to Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009566', 'term': 'Nitrates'}, {'id': 'D001120', 'term': 'Arginine'}, {'id': 'D002956', 'term': 'Citrulline'}], 'ancestors': [{'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017942', 'term': 'Nitric Acid'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2021-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-28', 'studyFirstSubmitDate': '2016-05-18', 'studyFirstSubmitQcDate': '2016-07-26', 'lastUpdatePostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neuromuscular evaluations', 'timeFrame': '3 half days', 'description': 'After the intake of the supplement. Measure the stretching force in the ankle (N)'}, {'measure': 'Evaluation of post-ischemic vascular reactivity', 'timeFrame': '3 half days', 'description': 'After the intake of the supplement. Concentration of hemoglobin (g/mL) in the quadriceps with the device : NIRS system Oxymon, ARTINIS.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Physiology']}, 'referencesModule': {'references': [{'pmid': '22691607', 'type': 'BACKGROUND', 'citation': 'Alvares TS, Conte-Junior CA, Silva JT, Paschoalin VM. Acute L-Arginine supplementation does not increase nitric oxide production in healthy subjects. Nutr Metab (Lond). 2012 Jun 12;9(1):54. doi: 10.1186/1743-7075-9-54.'}, {'pmid': '22251130', 'type': 'BACKGROUND', 'citation': 'Alvares TS, Conte CA, Paschoalin VM, Silva JT, Meirelles Cde M, Bhambhani YN, Gomes PS. Acute l-arginine supplementation increases muscle blood volume but not strength performance. Appl Physiol Nutr Metab. 2012 Feb;37(1):115-26. doi: 10.1139/h11-144. Epub 2012 Jan 17.'}, {'pmid': '22965792', 'type': 'BACKGROUND', 'citation': 'Bachasson D, Guinot M, Wuyam B, Favre-Juvin A, Millet GY, Levy P, Verges S. Neuromuscular fatigue and exercise capacity in fibromyalgia syndrome. Arthritis Care Res (Hoboken). 2013 Mar;65(3):432-40. doi: 10.1002/acr.21845.'}, {'pmid': '24001968', 'type': 'BACKGROUND', 'citation': 'Bachasson D, Temesi J, Bankole C, Lagrange E, Boutte C, Millet GY, Verges S, Levy P, Feasson L, Wuyam B. Assessement of quadriceps strength, endurance and fatigue in FSHD and CMT: benefits and limits of femoral nerve magnetic stimulation. Clin Neurophysiol. 2014 Feb;125(2):396-405. doi: 10.1016/j.clinph.2013.08.001. Epub 2013 Aug 31.'}, {'pmid': '24324843', 'type': 'BACKGROUND', 'citation': 'Bachasson D, Wuyam B, Pepin JL, Tamisier R, Levy P, Verges S. Quadriceps and respiratory muscle fatigue following high-intensity cycling in COPD patients. 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Epub 2013 Feb 20.'}, {'pmid': '23903463', 'type': 'BACKGROUND', 'citation': 'Vega-Villa K, Pluta R, Lonser R, Woo S. Quantitative Systems Pharmacology Model of NO Metabolome and Methemoglobin Following Long-Term Infusion of Sodium Nitrite in Humans. CPT Pharmacometrics Syst Pharmacol. 2013 Jul 31;2(7):e60. doi: 10.1038/psp.2013.35.'}, {'pmid': '18756009', 'type': 'BACKGROUND', 'citation': 'Verges S, Maffiuletti NA, Kerherve H, Decorte N, Wuyam B, Millet GY. Comparison of electrical and magnetic stimulations to assess quadriceps muscle function. J Appl Physiol (1985). 2009 Feb;106(2):701-10. doi: 10.1152/japplphysiol.01051.2007. Epub 2008 Aug 28.'}, {'pmid': '20388537', 'type': 'BACKGROUND', 'citation': 'Villanueva C, Giulivi C. Subcellular and cellular locations of nitric oxide synthase isoforms as determinants of health and disease. Free Radic Biol Med. 2010 Aug 1;49(3):307-16. doi: 10.1016/j.freeradbiomed.2010.04.004. Epub 2010 Apr 11.'}, {'pmid': '10862539', 'type': 'BACKGROUND', 'citation': 'Vuillemin A, Oppert JM, Guillemin F, Essermeant L, Fontvieille AM, Galan P, Kriska AM, Hercberg S. Self-administered questionnaire compared with interview to assess past-year physical activity. Med Sci Sports Exerc. 2000 Jun;32(6):1119-24. doi: 10.1097/00005768-200006000-00013.'}, {'pmid': '1593914', 'type': 'BACKGROUND', 'citation': 'Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.'}, {'pmid': '23640589', 'type': 'BACKGROUND', 'citation': 'Wylie LJ, Kelly J, Bailey SJ, Blackwell JR, Skiba PF, Winyard PG, Jeukendrup AE, Vanhatalo A, Jones AM. Beetroot juice and exercise: pharmacodynamic and dose-response relationships. J Appl Physiol (1985). 2013 Aug 1;115(3):325-36. doi: 10.1152/japplphysiol.00372.2013. Epub 2013 May 2.'}, {'pmid': '23370859', 'type': 'BACKGROUND', 'citation': 'Wylie LJ, Mohr M, Krustrup P, Jackman SR, Ermiotadis G, Kelly J, Black MI, Bailey SJ, Vanhatalo A, Jones AM. Dietary nitrate supplementation improves team sport-specific intense intermittent exercise performance. Eur J Appl Physiol. 2013 Jul;113(7):1673-84. doi: 10.1007/s00421-013-2589-8. Epub 2013 Feb 1.'}, {'pmid': '22957482', 'type': 'BACKGROUND', 'citation': 'Zhu Q, Yue X, Tian QY, Saren G, Wu MH, Zhang Y, Liu TT. Effect of L-arginine supplementation on blood pressure in pregnant women: a meta-analysis of placebo-controlled trials. Hypertens Pregnancy. 2013;32(1):32-41. doi: 10.3109/10641955.2012.697952. Epub 2012 Sep 7.'}]}, 'descriptionModule': {'briefSummary': 'NO is an ubiquitous molecule contributing to many physiological functions such as vasodilation, immune and oxidative stress responses. NO production can be supplemented either by providing substrate to the NO-synthase (L-Arginine and L-Citruline) or by providing nitrate which can lead to NO. In the present project the investigators evaluate the effect of various acute and chronic oral NO precursors supplementation on exercise performance and responses in healthy young and older subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sedentary subjects\n* No cardiovascular, respiratory, metabolic and neurological disorders\n\nExclusion Criteria:\n\n* Body mass index \\> 28 kg.m-2\n* Smoker\n* Alcool intake \\> 10g/day\n* Psychiatric diseases\n* Subjects under treatment able to interfere with their cardiovascular, metabolic and neurological status'}, 'identificationModule': {'nctId': 'NCT02850367', 'acronym': 'NO-SUP', 'briefTitle': 'Effect of NO Precursors on Physiological Responses to Exercise', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'The Effect of NO Precursors on Physiological Responses to Exercise', 'orgStudyIdInfo': {'id': '38RC14.430'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Acute intake', 'description': 'Evaluation after acute intake of the food supplement.', 'interventionNames': ['Dietary Supplement: Nitrate', 'Dietary Supplement: Nitrate and L-Arginine', 'Dietary Supplement: Nitrate and L-Citrulline', 'Dietary Supplement: Placebo', 'Biological: Evaluation of post-ischemic vascular reactivity', 'Biological: Neuromuscular evaluations']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chronic intake', 'description': 'Evaluation before and after chronic intake of the food supplement.', 'interventionNames': ['Dietary Supplement: Nitrate and L-Citrulline', 'Dietary Supplement: Placebo', 'Biological: Evaluation of post-ischemic vascular reactivity', 'Biological: Neuromuscular evaluations']}], 'interventions': [{'name': 'Nitrate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Subjects will be supplemented orally either acutely or chronically (4-8 weeks) with NO precursors.', 'armGroupLabels': ['Acute intake']}, {'name': 'Nitrate and L-Arginine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Subjects will be supplemented orally either acutely or chronically (4-8 weeks) with NO precursors.', 'armGroupLabels': ['Acute intake']}, {'name': 'Nitrate and L-Citrulline', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Subjects will be supplemented orally either acutely or chronically (4-8 weeks) with NO precursors.', 'armGroupLabels': ['Acute intake', 'Chronic intake']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Subjects will be supplemented orally either acutely or chronically (4-8 weeks) with a placebo.', 'armGroupLabels': ['Acute intake', 'Chronic intake']}, {'name': 'Evaluation of post-ischemic vascular reactivity', 'type': 'BIOLOGICAL', 'description': 'After the intake of the supplement. Concentration of hemoglobin (g/mL) in the quadriceps with the device : NIRS system Oxymon, ARTINIS.', 'armGroupLabels': ['Acute intake', 'Chronic intake']}, {'name': 'Neuromuscular evaluations', 'type': 'BIOLOGICAL', 'description': 'After the intake of the supplement. Measure the stretching force in the ankle (N)', 'armGroupLabels': ['Acute intake', 'Chronic intake']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'Grenoble University Hospital', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Stéphane Doutreleau, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}