Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-29 @ 10:31 AM
Study NCT ID:
NCT06618261
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-10-01
First Post:
2024-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Caffeine and Resistance Training in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002110', 'term': 'Caffeine'}], 'ancestors': [{'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-26', 'studyFirstSubmitDate': '2024-09-09', 'studyFirstSubmitQcDate': '2024-09-26', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean velocity at different %1RM', 'timeFrame': 'Through study completion, an average of 12 weeks', 'description': 'Measuring bar mean velocity desplacement during bench press and back squat exercises.'}, {'measure': 'Peak velocity at different %1RM', 'timeFrame': 'Through study completion, an average of 12 weeks', 'description': 'Measuring bar peak velocity and time to reach peak velocity of bar desplacement during bench press and back squat exercises.'}, {'measure': 'Mean power output at different %1RM', 'timeFrame': 'Through study completion, an average of 12 weeks', 'description': 'Measuring during bench press and back squat exercises.'}, {'measure': 'Peak power output and time to reach peak power output at different %1RM', 'timeFrame': 'Through study completion, an average of 12 weeks', 'description': 'Measuring during bench press and back squat exercises.'}, {'measure': 'Number of repetitions performed at 65%1RM until task failure', 'timeFrame': 'Through study completion, an average of 12 weeks', 'description': 'In bench press and back squat exercises'}, {'measure': 'Bar velocity deplacement performed in 1 set at 65%1RM until task failure', 'timeFrame': 'Through study completion, an average of 12 weeks', 'description': 'In bench press and back squat exercises'}, {'measure': 'Power output generated in 1 set at 65%1RM until task failure', 'timeFrame': 'Through study completion, an average of 12 weeks', 'description': 'In bench press and back squat exercise'}, {'measure': 'Resting Metabolic Rate (RMR)', 'timeFrame': 'Through study completion, an average of 12 weeks', 'description': 'Kcal at rest (RMR) using a metabolic chart.'}, {'measure': 'Maximal Fat Oxidation Rate (MFO)', 'timeFrame': 'Through study completion, an average of 12 weeks', 'description': 'g/min (MFO) using a metabolic chart.'}], 'secondaryOutcomes': [{'measure': 'Fat mass', 'timeFrame': 'Through study completion, an average of 12 weeks', 'description': 'Using electrical bioimpedance and untrasound in the quadriceps muscle'}, {'measure': 'Fat-free mass', 'timeFrame': 'Through study completion, an average of 12 weeks', 'description': 'Using electrical bioimpedance and untrasound in the quadriceps muscle'}, {'measure': 'Physical activity (METs-min/wk)', 'timeFrame': 'Through study completion, an average of 12 weeks', 'description': 'Using IPAQ'}, {'measure': 'Dietary (g/kg of macronutrients)', 'timeFrame': 'Through study completion, an average of 12 weeks', 'description': 'Using a 24-total recall'}, {'measure': 'Mood state', 'timeFrame': 'Through study completion, an average of 12 weeks', 'description': 'Mood. 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': 'Through study completion, an average of 12 weeks', 'description': 'Adverse effects. perception of power, endurance, energy and exertion, as well as heart, muscular and gastrointestinal discomfort.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Caffeine and Resistance Training']}, 'descriptionModule': {'briefSummary': 'Introduction: Several studies have evaluated and confirmed the ergogenic effect of acute caffeine intake on sports performance, specifically on strength and power performance. However, little is known about the prolonged effects of this supplement on neuromuscular adaptations to strength training.\n\nObjectives: The present study aims to analyze the effects of acute and chronic caffeine intake on neuromuscular adaptations to strength training, according to sex (men vs. women) and type of exercise (bench press vs. squat), as well as fatigue perception, mood state, and potential side effects in older adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between ≥ 55\n* Body mass index (BMI) ≥ 30 kg/m².\n* Physically active subjects (\\>150 min/week of moderate exercise).\n* Healthy men and women without neurological, cardiometabolic, immunological, or physical conditions that prevent them from performing physical exercise.\n* Participants capable of performing the tests.\n\nExclusion Criteria:\n\n* History of neuromuscular, cardiac, or diseases that could affect liver or muscle metabolism.\n* Use of drugs or other stimulants that interfere with caffeine intake and intestinal absorption during the tests and study.\n* Having undergone prolonged periods of forced physical inactivity during the 6 months prior to the study.\n* Performing strenuous exercise within 48 hours prior to the tests.\n* Failing to replicate the same food intake on the two experimental days.\n* Consuming caffeine after 6 PM on the day prior to training or testing.'}, 'identificationModule': {'nctId': 'NCT06618261', 'briefTitle': 'Caffeine and Resistance Training in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Alcala'}, 'officialTitle': 'Effects of Acute and Prolonged Caffeine Intake on Neuromuscular Adaptations to Resistance Training in Older Adults', 'orgStudyIdInfo': {'id': 'CEIP/2022/3/055'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Caffeine - Males', 'interventionNames': ['Dietary Supplement: Caffeine + Resistance exercise']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo - Males', 'interventionNames': ['Dietary Supplement: Placebo + Resistance exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Caffeine - Females', 'interventionNames': ['Dietary Supplement: Caffeine + Resistance exercise']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo - Females', 'interventionNames': ['Dietary Supplement: Placebo + Resistance exercise']}], 'interventions': [{'name': 'Caffeine + Resistance exercise', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Acute caffeine intake (3 mg/kg) prior each resistance training session of a 8 weeks training program.', 'armGroupLabels': ['Caffeine - Females', 'Caffeine - Males']}, {'name': 'Placebo + Resistance exercise', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Acute placeb intake (3 mg/kg of maltodextrin) prior each resistance training session of a 8 weeks training program.', 'armGroupLabels': ['Placebo - Females', 'Placebo - Males']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28805', 'city': 'Alcalá de Henares', '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': 'Alberto Pérez-López', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Alcala', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alberto Pérez-López', 'investigatorAffiliation': 'University of Alcala'}}}}