Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-02-26 @ 11:00 AM
Study NCT ID:
NCT05460351
Status:
COMPLETED
Last Update Posted:
2022-07-15
First Post:
2022-07-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Beetroot Juice Resistance Training Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D001284', 'term': 'Atrophy'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'A third party not involved with the conduct of the study provided research staff with the beetroot juice in participant specific coded bottles. The research staff then distributed these coded bottles to the participant. At the end of the trial, the code was revealed for intervention assignment.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized into one of two groups. The first group will consume daily beetroot juice containing 380 mg of nitrate and the second group will consume daily beetroot juice with nitrate removed. Both groups will undergo resistance exercise training and consume a protein supplement'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-12', 'studyFirstSubmitDate': '2022-07-04', 'studyFirstSubmitQcDate': '2022-07-12', 'lastUpdatePostDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Whole body fat free mass', 'timeFrame': 'Collected at baseline', 'description': 'Mass of fat free tissue'}, {'measure': 'Whole body fat mass', 'timeFrame': 'Collected at baseline', 'description': 'Mass of fat tissue'}, {'measure': 'Thigh muscle', 'timeFrame': 'Collected at baseline', 'description': 'Volume of thigh muscle'}, {'measure': 'Thigh intermuscular fat', 'timeFrame': 'Collected at baseline', 'description': 'Volume of fat in the thigh muscle'}, {'measure': 'Thigh subcutaneous fat', 'timeFrame': 'Collected at baseline', 'description': 'Volume of subcutaneous fat in the thigh'}, {'measure': 'Visceral fat', 'timeFrame': 'Collected at baseline', 'description': 'Volume of visceral fat'}, {'measure': 'Muscle strength', 'timeFrame': 'Collected at baseline', 'description': 'Strength of quadriceps muscle at a speed of 60 degrees per second'}, {'measure': '400 meter walk', 'timeFrame': 'Collected at baseline', 'description': 'Time to walk 400 meters'}, {'measure': 'Stair climb time', 'timeFrame': 'Collected at baseline', 'description': 'Time to ascend and descend 12 stairs'}, {'measure': 'Peak oxygen consumption', 'timeFrame': 'Collected at baseline', 'description': 'Peak oxygen consumed at maximal exercise during graded exercise testing'}, {'measure': 'Whole body fat free mass', 'timeFrame': 'Collected at 10-weeks', 'description': 'mass of fat free tissue'}, {'measure': 'Whole body fat mass', 'timeFrame': 'Collected at 10-weeks', 'description': 'Mass of fat tissue'}, {'measure': 'Thigh muscle', 'timeFrame': 'Collected at 10-weeks', 'description': 'Volume of thigh muscle'}, {'measure': 'Thigh intermuscular fat', 'timeFrame': 'Collected at 10-weeks', 'description': 'Volume of fat in the thigh muscle'}, {'measure': 'Thigh subcutaneous fat', 'timeFrame': 'Collected at 10-weeks', 'description': 'Volume of subcutaneous fat in the thigh'}, {'measure': 'Visceral fat', 'timeFrame': 'Collected at 10-weeks', 'description': 'Volume of visceral fat'}, {'measure': 'Muscle strength', 'timeFrame': 'Collected at 10-weeks', 'description': 'Strength of quadriceps muscle at a speed of 60 degrees per second'}, {'measure': '400 meter walk', 'timeFrame': 'Collected at 10-weeks', 'description': 'Time to walk 400 meters'}, {'measure': 'Stair climb time', 'timeFrame': 'Collected at 10-weeks', 'description': 'Time to ascend and descend 12 stairs'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sarcopenia', 'Old Age; Atrophy']}, 'descriptionModule': {'briefSummary': 'The present study compared the effects of a nitrate containing beetroot juice supplement (BRJ+Nitrate) vs. a placebo (Control) on total and regional fat free mass, quadriceps muscle strength, lower body mobility, and VO2peak in healthy, older adults undergoing a 10-week long progressive resistance training program with protein supplementation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to provide own transportation to study testing visits and intervention\n* Able to read and write in English\n* Nondiabetic, i.e. fasting glucose \\< 126 mg/dl\n* Sedentary (less than 60 minutes of moderate intensity structured physical activity each week and occurs in no more than 10 minute blocks and not participating in a resistance exercise training program)\n* Willingness to provide informed consent and participate in intervention. Participants with diagnosed depression were permitted to participate provided that they have been medically stable without medication change for at least 3 months.\n\nExclusion Criteria:\n\n* Smoking or use of chewing tobacco\n* Involved in another intervention research study\n* Diabetic (type 1 or 2)\n* Atrophic gastritis\n* Hypo- or hyperthyroidism\n* Gout or history of kidney stones\n* History of hypotension\n* Premenopausal (women)\n* Aversion to study-related testing procedures\n* Allergy/sensitivity/aversion to beetroot beverages or protein supplement\n* Medical conditions with contraindications for engaging in resistance training program or taking the protein supplement\n* Systemic, uncontrolled diseases (diabetes, recent (last 6 months) or current treatment of cancer, thyroid disorders, cardiovascular disease, COPD, or inflammatory bowel diseases)\n* Use of any of the following medications: phosphodiesterase type 5 inhibitors, nitroglycerin or nitrate preparations, proton pump inhibitors, or medications for hypothyroidism\n* Potential inability to complete the tasks required for the protocol as well as conditions that may interfere with interpretation of results including: inability to ambulate, severe congestive heart failure or severe cardiovascular disease, neoplasm for practical and neurophysiologic reasons\n* Individuals with contraindications for performing a graded exercise test or have medical contraindications for participating in a scheduled exercise training program\n* Individuals more than 300 pounds or less than 125 pounds due to DEXA weight limits and possibility of exceeding recommended daily nitrate dose of 7 mg/kg body weight, respectively.'}, 'identificationModule': {'nctId': 'NCT05460351', 'briefTitle': 'Beetroot Juice Resistance Training Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University'}, 'officialTitle': 'Effect of Beetroot Juice on Body Composition, Physical Function, Muscle Strength, and Peak Oxygen Consumption in Resistance Trained Older Adults Consuming a Protein Supplement', 'orgStudyIdInfo': {'id': 'IRB00025941'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BRJ+Nitrate', 'description': 'This arm underwent a 3 days a week, 10 weeks of resistance exercise training program and consumed for a 70 mL bottle of beetroot juice containing 380 mg of nitrate plus a 15 dose of whey protein after each exercise session.', 'interventionNames': ['Dietary Supplement: BRJ+Nitrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'This arm underwent a 3 days a week, 10 weeks of resistance exercise training program and consumed for a 70 mL bottle of beetroot juice containing 0 mg of nitrate plus a 15 dose of whey protein after each exercise session.', 'interventionNames': ['Dietary Supplement: Control']}], 'interventions': [{'name': 'BRJ+Nitrate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants in this group drank a 70 mL bottle of Beet It Sport drink with nitrate plus 15 grams of whey protein 3 days a week following a resistance exercise training program', 'armGroupLabels': ['BRJ+Nitrate']}, {'name': 'Control', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants in this group drank a 70 mL bottle of Beet It Sport drink without nitrate plus 15 grams of whey protein 3 days a week following a resistance exercise training program', 'armGroupLabels': ['Control']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Gary Miller', 'investigatorAffiliation': 'Wake Forest University'}}}}