Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2025-12-30 @ 4:22 PM
Study NCT ID:
NCT03585868
Status:
COMPLETED
Last Update Posted:
2018-07-13
First Post:
2018-05-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of COcoa Supplement in FRail Elderly Subjects (COFRE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005419', 'term': 'Flavonoids'}], 'ancestors': [{'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-12', 'studyFirstSubmitDate': '2018-05-16', 'studyFirstSubmitQcDate': '2018-07-12', 'lastUpdatePostDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood glucose', 'timeFrame': 'At 90 days', 'description': 'Fasting blood level'}, {'measure': 'Serum triacylglycerol concentration', 'timeFrame': 'At 90 days', 'description': 'Fasting blood level'}, {'measure': 'Serum total cholesterol', 'timeFrame': 'At 90 days', 'description': 'Fasting blood level'}, {'measure': 'Serum HDL cholesterol', 'timeFrame': 'At 90 days', 'description': 'Fasting blood level'}, {'measure': 'Serum LDL cholesterol', 'timeFrame': 'At 90 days', 'description': 'Fasting blood level'}, {'measure': 'Lipid oxidation', 'timeFrame': 'At 90 days', 'description': 'Serum malondialdehyde Levels'}, {'measure': 'Protein oxidation', 'timeFrame': 'At 90days', 'description': 'Serum protein carbonylation Levels'}], 'secondaryOutcomes': [{'measure': 'Handgrip strength', 'timeFrame': 'At 60 days', 'description': 'Measures static force in kilograms that the hand can squeeze around a dynamometer'}, {'measure': 'Up and go test', 'timeFrame': 'At 60 days', 'description': 'Measures time in seconds, a subject can rise and walk a 3-meter line and return to sit down'}, {'measure': 'Six-minute walk test', 'timeFrame': '6 minutes', 'description': 'Measures maximum distance in meters, a subject can walk at their normal gait and pace during 6 minutes'}, {'measure': 'Two-minute step in place test', 'timeFrame': '2 minutes', 'description': 'Measures number of times a subject can rise each knee to the hip level during 2 minutes.'}, {'measure': 'Sit-up test', 'timeFrame': '30 seconds', 'description': 'Measures number of times a subject can rise and sit-down in place during 30 seconds'}, {'measure': 'EQ-5D questionnaire', 'timeFrame': 'At 60 days', 'description': 'Self-administered health index that explores five domains'}, {'measure': 'Analog Visual Scale', 'timeFrame': 'At 60 days', 'description': 'Use of a Analog Visual Scale to measure the quality of life, graded 0 (worst) to 100 (best) for the perception of wellbeing.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['flavonoids'], 'conditions': ['Sarcopenia', 'Frail Elderly Syndrome']}, 'referencesModule': {'references': [{'pmid': '31056655', 'type': 'DERIVED', 'citation': 'Munguia L, Rubio-Gayosso I, Ramirez-Sanchez I, Ortiz A, Hidalgo I, Gonzalez C, Meaney E, Villarreal F, Najera N, Ceballos G. High Flavonoid Cocoa Supplement Ameliorates Plasma Oxidative Stress and Inflammation Levels While Improving Mobility and Quality of Life in Older Subjects: A Double-Blind Randomized Clinical Trial. J Gerontol A Biol Sci Med Sci. 2019 Sep 15;74(10):1620-1627. doi: 10.1093/gerona/glz107.'}]}, 'descriptionModule': {'briefSummary': 'The study use a double blind, placebo-controlled design enrolling male and female subjects between 55-90 yo to evaluate the effect of daily consumption of a cocoa beverage on anthropometric, metabolic, oxidative stress, physical performance and quality of life.', 'detailedDescription': 'The study use a double blind, placebo-controlled design enrolling male and female subjects between 55-90 yo randomly assigned to consumption of a flavonoid rich mixture (flavonoids; F), alkalinized cocoa which eliminates flavonoid content (no flavonoids; NF) or placebo. All beverages had similar physical characteristics and flavor. Cocoa beverages were provided in individual sachets containing a dry powder that was reconstituted with water just before consumption. Subjects were instructed as above to maintain their usual lifestyle, to limit intake of high caloric foods and flavonoid-containing foods and beverages, and to walk for 30 min/day.\n\nTo determine the effect of flavonoids, study evaluates anthropometric measures, metabolic parameters as glycemia and a lipid profile (triglycerides, total cholesterol, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol). To evaluate oxidative stress damage as lipid oxidation is measured with the malondialdehyde (MDA) assay. Protein carbonylation is measured using an assay for detection of carbonyl groups that relies on 2,4-dinitrophenylhydrazine (DNPH) as a substrate. The investigators also evaluate interleukin-6 and tumor necrosis factor levels.\n\nFor physical performance is evaluated the handgrip strength, and mobility assesment with the following test: Six-minute walk test, two-minute step, sit-up test and the up \\& go test.\n\nThe investigators also assessed quality of life using the Health Related QoL (EQ-5D) questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sex: both\n* Age: 55-90 yo\n* Waist circumference: Women \\> 80 cm, Men \\> 90 cm\n* HDL-c: Women \\< 50 mg/dL, Men \\< 40 mg/dL\n* Triglycerides: ≥ 150 mg/dL\n* Glycemia: ≈100 mg/dL\n* Hand strength: Women\\< 20 kg, Men \\< 30 kg\n* Up \\& Go test: \\> 10 seconds\n\nNon-inclusion criteria:\n\n* Any active infections\n* Malignancies\n* Habitual consumers of antioxidant supplements and cocoa products\n* Use of benzodiazepines or protein supplements'}, 'identificationModule': {'nctId': 'NCT03585868', 'acronym': 'COFRE', 'briefTitle': 'Effects of COcoa Supplement in FRail Elderly Subjects (COFRE)', 'organization': {'class': 'OTHER', 'fullName': 'National Polytechnic Institute, Mexico'}, 'officialTitle': 'Evaluation of the Effects of a COcoa Supplement to Reduce FRailty in the Elderly: COFRE a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'COFRE-LIICM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Beverage without flavonoids', 'interventionNames': ['Other: Placebo']}, {'type': 'SHAM_COMPARATOR', 'label': 'No Flavonoids', 'description': 'Beverage with alkalinized cocoa which eliminates flavonoid content', 'interventionNames': ['Dietary Supplement: No Flavonoids']}, {'type': 'EXPERIMENTAL', 'label': 'Flavonoids', 'description': 'Beverage with a flavonoid rich mixture', 'interventionNames': ['Other: Flavonoids']}], 'interventions': [{'name': 'Placebo', 'type': 'OTHER', 'description': 'Beverage with no flavonoids', 'armGroupLabels': ['Placebo']}, {'name': 'Flavonoids', 'type': 'OTHER', 'description': 'Flavonoids-enriched cacao beverage', 'armGroupLabels': ['Flavonoids']}, {'name': 'No Flavonoids', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Beverage with alkalinized cocoa which eliminates flavonoid content', 'armGroupLabels': ['No Flavonoids']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Polytechnic Institute, Mexico', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Guillermo Ceballos Reyes', 'investigatorAffiliation': 'National Polytechnic Institute, Mexico'}}}}