Effects of COcoa Supplement in FRail Elderly Subjects (COFRE)

Study Overview
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Brief Summary
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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.

Detailed Description
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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. To 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. For 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. The investigators also assessed quality of life using the Health Related QoL (EQ-5D) questionnaire.

Official Title
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Evaluation of the Effects of a COcoa Supplement to Reduce FRailty in the Elderly: COFRE a Randomized Clinical Trial

Conditions
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Sarcopenia, Frail Elderly Syndrome

Intervention / Treatment
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* Other: Placebo
* Other: Flavonoids
* Dietary Supplement: No Flavonoids


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sex: both Age: 55-90 yo Waist circumference: Women > 80 cm, Men > 90 cm HDL-c: Women < 50 mg/dL, Men < 40 mg/dL Triglycerides: ≥ 150 mg/dL Glycemia: ≈100 mg/dL Hand strength: Women< 20 kg, Men < 30 kg Up & Go test: > 10 seconds Non-inclusion criteria: Any active infections Malignancies Habitual consumers of antioxidant supplements and cocoa products Use of benzodiazepines or protein supplements

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Beverage without flavonoids | Other: Placebo<br>* Beverage with no flavonoids<br>|
| Sham Comparator: No Flavonoids<br>Beverage with alkalinized cocoa which eliminates flavonoid content | Dietary Supplement: No Flavonoids<br>* Beverage with alkalinized cocoa which eliminates flavonoid content<br>|
| Experimental: Flavonoids<br>Beverage with a flavonoid rich mixture | Other: Flavonoids<br>* Flavonoids-enriched cacao beverage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose | Fasting blood level | At 90 days | 
| Serum triacylglycerol concentration | Fasting blood level | At 90 days | 
| Serum total cholesterol | Fasting blood level | At 90 days | 
| Serum HDL cholesterol | Fasting blood level | At 90 days | 
| Serum LDL cholesterol | Fasting blood level | At 90 days | 
| Lipid oxidation | Serum malondialdehyde Levels | At 90 days | 
| Protein oxidation | Serum protein carbonylation Levels | At 90days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Handgrip strength | Measures static force in kilograms that the hand can squeeze around a dynamometer | At 60 days | 
| Up and go test | Measures time in seconds, a subject can rise and walk a 3-meter line and return to sit down | At 60 days | 
| Six-minute walk test | Measures maximum distance in meters, a subject can walk at their normal gait and pace during 6 minutes | 6 minutes | 
| Two-minute step in place test | Measures number of times a subject can rise each knee to the hip level during 2 minutes. | 2 minutes | 
| Sit-up test | Measures number of times a subject can rise and sit-down in place during 30 seconds | 30 seconds | 
| EQ-5D questionnaire | Self-administered health index that explores five domains | At 60 days | 
| Analog Visual Scale | Use of a Analog Visual Scale to measure the quality of life, graded 0 (worst) to 100 (best) for the perception of wellbeing. | At 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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flavonoids