Effects of COcoa Supplement in FRail Elderly Subjects (COFRE)

NCT ID: NCT03585868

Last Updated: 2018-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2017-12-31

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.

Conditions

Sarcopenia; Frail Elderly Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Beverage without flavonoids

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Beverage with no flavonoids

No Flavonoids

Beverage with alkalinized cocoa which eliminates flavonoid content

Group Type: SHAM_COMPARATOR

No Flavonoids

Intervention Type: DIETARY_SUPPLEMENT

Beverage with alkalinized cocoa which eliminates flavonoid content

Flavonoids

Beverage with a flavonoid rich mixture

Group Type: EXPERIMENTAL

Flavonoids

Intervention Type: OTHER

Flavonoids-enriched cacao beverage

Interventions

Placebo

Beverage with no flavonoids

Intervention Type: OTHER

Flavonoids

Flavonoids-enriched cacao beverage

Intervention Type: OTHER

No Flavonoids

Beverage with alkalinized cocoa which eliminates flavonoid content

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Any active infections
• Malignancies
• Habitual consumers of antioxidant supplements and cocoa products
• Use of benzodiazepines or protein supplements

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Polytechnic Institute, Mexico

OTHER

Sponsor Role: lead

Responsible Party

Guillermo Ceballos Reyes

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 31056655 (View on PubMed)

Other Identifiers

COFRE-LIICM

Identifier Type: -

Identifier Source: org_study_id