Effects of COcoa Supplement in FRail Elderly Subjects (COFRE)

Not Applicable

Completed

• Conditions: Sarcopenia; Frail Elderly Syndrome
• Interventions: Other: Flavonoids; Other: Placebo; Dietary Supplement: No Flavonoids

• Registration Number: NCT03585868
• Lead Sponsor: National Polytechnic Institute, Mexico

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-01
• Primary Completion: 2017-10
• Study Completion: 2017-12
• Study First Submitted: 2018-05-16
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-12
• Last Update Submitted: 2018-07-12
• Study First Posted: 2018-07-13
• Last Update Posted: 2018-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flavonoids	Flavonoids	Beverage with a flavonoid rich mixture
Placebo	Placebo	Beverage without flavonoids
No Flavonoids	No Flavonoids	Beverage with alkalinized cocoa which eliminates flavonoid content

Primary Outcome Measures

Name	Time	Method
Lipid oxidation	At 90 days	Serum malondialdehyde Levels
Serum total cholesterol	At 90 days	Fasting blood level
Protein oxidation	At 90days	Serum protein carbonylation Levels
Serum triacylglycerol concentration	At 90 days	Fasting blood level
Serum HDL cholesterol	At 90 days	Fasting blood level
Blood glucose	At 90 days	Fasting blood level
Serum LDL cholesterol	At 90 days	Fasting blood level

Secondary Outcome Measures

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