Effects of COcoa Supplement in FRail Elderly Subjects (COFRE)

National Polytechnic Institute, Mexico

Status: Completed

Conditions: Sarcopenia; Frail Elderly Syndrome

Treatments: Other: Placebo; Other: Flavonoids; Dietary Supplement: No Flavonoids

Study type: Interventional

Funder types: Other

Identifiers

NCT03585868

COFRE-LIICM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Beverage without flavonoids

Treatment:

Other: Placebo

No Flavonoids

Sham Comparator group

Description:

Beverage with alkalinized cocoa which eliminates flavonoid content

Treatment:

Dietary Supplement: No Flavonoids

Flavonoids

Experimental group

Description:

Beverage with a flavonoid rich mixture

Treatment:

Other: Flavonoids