Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT04787718
Status:
COMPLETED
Last Update Posted:
2022-05-05
First Post:
2021-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Almond for Physical Performance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063806', 'term': 'Myalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-03', 'studyFirstSubmitDate': '2021-03-03', 'studyFirstSubmitQcDate': '2021-03-05', 'lastUpdatePostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes from baseline in energy (vigor) perception', 'timeFrame': 'At baseline , at 8 weeks', 'description': 'Energy (vigor) perception will be assessed using POMS questionnaire'}, {'measure': 'Changes from baseline in exercise performance', 'timeFrame': 'At baseline , at 8 weeks', 'description': 'VO2max will be assessed for measuring exercise performance'}], 'secondaryOutcomes': [{'measure': 'Changes from baseline in strength and power performance', 'timeFrame': 'At baseline, at 8 weeks', 'description': 'strength and power performance by be measure by biodex'}, {'measure': 'Changes from baseline in muscle soreness', 'timeFrame': 'At baseline, at 8 weeks', 'description': 'muscle soreness will be measured by DOMES questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Muscle Soreness', 'Energy']}, 'referencesModule': {'references': [{'pmid': '39257478', 'type': 'DERIVED', 'citation': 'Rayo VU, Cervantes M, Hong MY, Hooshmand S, Jason N, Liu C, North E, Okamoto L, Storm S, Witard OC, Kern M. Almond Consumption Modestly Improves Pain Ratings, Muscle Force Production, and Biochemical Markers of Muscle Damage Following Downhill Running in Mildly Overweight, Middle-Aged Adults: A Randomized, Crossover Trial. Curr Dev Nutr. 2024 Aug 7;8(9):104432. doi: 10.1016/j.cdnut.2024.104432. eCollection 2024 Sep.'}]}, 'descriptionModule': {'briefSummary': 'Investigators specific aims are to compare the effects of consuming daily snacks of raw, shelled, unsalted almonds (2.0 ounces) versus an isocaloric amount of another commonly consumed snack food (pretzels) on energy (vigor) perception and physical activity, exercise performance (VO2max and measures of strength), strength and power performance as well as muscle soreness recovery after strenuous eccentrically-biased exercise.', 'detailedDescription': 'To accomplish these aims, investigators will examine whether regular consumption of almonds versus a common snack food over a period of 8 weeks impacts longer term metabolic, physiological and behavioral responses related to energy sensations and exercise capacity/performance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 30-50 years old\n* BMI of 23-30\n\nExclusion Criteria:\n\n* smoking,\n* medications known to impact inflammation,\n* musculoskeletal limitations and\n* use of supplements within 1 month of participation that are known to impact antioxidant\n* use of supplements within 1 month of participation that are known to impact inflammatory status'}, 'identificationModule': {'nctId': 'NCT04787718', 'briefTitle': 'Almond for Physical Performance', 'organization': {'class': 'OTHER', 'fullName': 'San Diego State University'}, 'officialTitle': 'Roles of Almonds in Physical Performance', 'orgStudyIdInfo': {'id': '59997A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Almond', 'description': 'Participants will consume 2.0 oz of raw, shelled, unsalted almonds.', 'interventionNames': ['Other: Almond']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'an isocaloric (2.0 oz raw almonds) amount of unsalted pretzels daily.', 'interventionNames': ['Other: Control group']}], 'interventions': [{'name': 'Almond', 'type': 'OTHER', 'description': '2.0 oz of raw, shelled, unsalted almonds', 'armGroupLabels': ['Almond']}, {'name': 'Control group', 'type': 'OTHER', 'description': 'an isocaloric amount of unsalted pretzels', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92182-7251', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego State University', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'San Diego State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mark Kern', 'investigatorAffiliation': 'San Diego State University'}}}}