Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-01-03 @ 8:18 PM
Study NCT ID:
NCT06596395
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2024-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Acute Caffeine and Beetroot Juice Intake on Strength, Power, and Muscular Endurance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Triple-blind, cross-over, randomized controlled-trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-10', 'studyFirstSubmitDate': '2024-09-06', 'studyFirstSubmitQcDate': '2024-09-10', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean and peak velocity and time to reach peak velocity at different %1RM', 'timeFrame': 'On each trial, after dietary supplement intake, during 2 weeks', 'description': 'Measuring bar velocity desplacement during bench press and back squat exercises.'}, {'measure': 'Mean and peak power output and time to reach peak power output at different %1RM', 'timeFrame': 'On each trial, after dietary supplement intake, during 2 weeks', 'description': 'Measuring power output generated during bench press and back squat exercises.'}, {'measure': 'Number of repetitions performed at 65%1RM until task failure', 'timeFrame': 'On each trial, after dietary supplement intake, during 2 weeks', 'description': 'Additionally to mean and peak velocity, mean and peak power output, time to reach peak velocity and peak power'}], 'secondaryOutcomes': [{'measure': 'Mood state (tension, depression, anger, vigor, fatigue and confusion)', 'timeFrame': 'On each trial, after dietary supplement intake, during 2 weeks', 'description': 'Participants graded a set of 29 items related to the mood on a Likert scale from 0 (not at all) to 4 (extremely) in reply to the question \\"How do you feel at this moment?\\" to assess six scales: tension, depression, anger, vigor, fatigue and confusion.'}, {'measure': 'Adverse effects', 'timeFrame': 'On each trial, after dietary supplement intake, during 2 weeks', 'description': 'perception of power, endurance, energy and exertion, as well as heart, muscular and gastrointestinal discomfort.'}, {'measure': 'handgrip and isometric mid-thigh pull tests', 'timeFrame': 'On each trial, after dietary supplement intake, during 2 weeks', 'description': 'N generated'}, {'measure': 'Vertical Jump (cm and power)', 'timeFrame': 'On each trial, after dietary supplement intake, during 2 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dietary Supplements', 'Caffeine', 'Nitrates', 'Sports Performance', 'Resistance Exercise']}, 'descriptionModule': {'briefSummary': 'Introduction: Several studies have evaluated and confirmed the ergogenic effect of acute caffeine and beetroot juice intake on sports performance. However, there are few studies focused on the production of strength, power, and muscle endurance, particularly when both supplements are ingested together.\n\nObjectives: Evaluate the acute effect of combined and isolated intake of caffeine and beetroot juice on the production of strength, power, and muscle endurance in young adults, analyzing the effect of circadian rhythms (morning vs. afternoon) on the exercise performed (bench press vs. squat).\n\nMethods: A total of 12 healthy and physically active participants will be recruited for the study. Through a double-blind, crossover, randomized, and controlled design, participants will ingest: a) Caffeine (3 mg/kg body mass); b) Beetroot juice (70 ml, 6.5 mmol of nitrates); c) Caffeine + Beetroot juice; d) Placebo (maltodextrin, 3 mg/kg). The supplements will be ingested 120 minutes (beetroot juice or placebo) and 60 minutes before (caffeine or placebo), the latter dissolved in 200 ml of water. After the ingestion period, strength, power, and muscle endurance will be analyzed with 1RM tests, strength and power tests at 25%, 50%, 75%, and 90% 1RM, and muscle endurance tests at 65% 1RM, in all cases for squat and bench press exercises. Additionally, dynamometry (manual and the isometric mid-thigh pull test) and vertical jump (squat jump and countermovement jump) will be analyzed. The four experimental conditions will be conducted in the morning (8:00 am to 10:00 am) and in the afternoon (4:30 pm to 6:30 pm).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between ≥ 18 and ≤ 35 years.\n* Body Mass Index (BMI) \\< 25 kg/m².\n* Resistance-trained individuals (\\> 2 years of structured trained).\n* Healthy men and women without neurological, cardiometabolic, immunological, or physical conditions that prevent them from exercising.\n* Participants must be able to perform the tests described in the following section.\n\nExclusion Criteria:\n\n* History of neuromuscular diseases, heart diseases, or diseases that may affect liver or muscle metabolism.\n* Use of drugs, other stimulants or sport supplements that interfere with the intake of the study\\'s dietary supplements.\n* Sedentary habits (\\< 150 min/week of moderate exercise).\n* Having undergone prolonged periods of forced physical inactivity during the 6 months prior to the study.\n* Performing strenuous exercise during the 48 hours prior to the tests.\n* Failure to replicate the same food intake on the two days of the experiments.\n* Consuming caffeine or any other stimulant after 6 pm the day before the training or tests, to avoid headaches, discomfort, or lethargy among regular caffeine consumers.\n* Consuming foods rich in NO3- (e.g., beetroot, spinach, or celery) during the 48 hours prior to each experimental condition.'}, 'identificationModule': {'nctId': 'NCT06596395', 'acronym': 'CAF+BJ', 'briefTitle': 'Effect of Acute Caffeine and Beetroot Juice Intake on Strength, Power, and Muscular Endurance', 'organization': {'class': 'OTHER', 'fullName': 'University of Alcala'}, 'officialTitle': 'Effect of Acute Caffeine and Beetroot Juice Intake on Strength, Power, and Muscular Endurance Based on Circadian Rhythms.', 'orgStudyIdInfo': {'id': 'CEIP/2023/4/093'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Caffeine + Beetroot Juice', 'description': '70 mL of concentrated NO3--rich (BJ, 6.5 mmol NO3-) + 3 mg/kg of caffeine', 'interventionNames': ['Dietary Supplement: Acute caffeine and beetroot juice']}, {'type': 'EXPERIMENTAL', 'label': 'Beetroot Juice', 'description': '70 mL of concentrated NO3--rich (BJ, 6.5 mmol NO3-) + 3 mg/kg of placebo (maltodextrin)', 'interventionNames': ['Dietary Supplement: Acute beetroot juice']}, {'type': 'EXPERIMENTAL', 'label': 'Caffeine', 'description': '70 mL of NO3--depleted (BJ, 0.04 mmol NO3-) + 3 mg/kg of caffeine', 'interventionNames': ['Dietary Supplement: Acute caffeine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '70 mL of NO3--depleted (BJ, 0.04 mmol NO3-) + 3 mg/kg of placebo (maltodextrin)', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Acute caffeine and beetroot juice', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Combined effect of beetroot juice and caffeine intake on muscular strength, power and endurance performance', 'armGroupLabels': ['Caffeine + Beetroot Juice']}, {'name': 'Acute caffeine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'single effect of caffeine intake on muscular strength, power and endurance performance', 'armGroupLabels': ['Caffeine']}, {'name': 'Acute beetroot juice', 'type': 'DIETARY_SUPPLEMENT', 'description': 'single effect of beetroot juice intake on muscular strength, power and endurance performance', 'armGroupLabels': ['Beetroot Juice']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'single effect of placebo on muscular strength, power and endurance performance', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28805', 'city': 'Alcalá de Henares', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Facultad de Medicina y Ciencias de la Salud. Universidad de Alcalá', 'geoPoint': {'lat': 40.48205, 'lon': -3.35996}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alcala', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alberto Pérez-López', 'investigatorAffiliation': 'University of Alcala'}}}}