Effects of COcoa Supplement in FRail Elderly Subjects (COFRE) (COFRE)

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

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.

Study Overview

• Status: Completed
• Conditions: Frail Elderly Syndrome; Sarcopenia
• Intervention / Treatment: Other: Placebo; Dietary supplement: No Flavonoids; Other: Flavonoids

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Polytechnic Institute, Mexico

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: May 16, 2018
• First Submitted That Met QC Criteria: July 12, 2018
• First Posted (Actual): July 13, 2018

Study Record Updates

• Last Update Posted (Actual): July 13, 2018
• Last Update Submitted That Met QC Criteria: July 12, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: flavonoids
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: COFRE-LIICM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No