Effects of COcoa Supplement in FRail Elderly Subjects (COFRE)

Sarcopenia Clinical Trial

— COFRE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03585868
• Other study ID #: COFRE-LIICM
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 2017

Study information

• Verified date: July 2018
• Source: National Polytechnic Institute, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Frail Elderly Syndrome
• Sarcopenia

Intervention

Other:
• Placebo
Beverage with no flavonoids
• Flavonoids
Flavonoids-enriched cacao beverage

Dietary Supplement:
• No Flavonoids
Beverage with alkalinized cocoa which eliminates flavonoid content

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Polytechnic Institute, Mexico

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose	Fasting blood level	At 90 days
Primary	Serum triacylglycerol concentration	Fasting blood level	At 90 days
Primary	Serum total cholesterol	Fasting blood level	At 90 days
Primary	Serum HDL cholesterol	Fasting blood level	At 90 days
Primary	Serum LDL cholesterol	Fasting blood level	At 90 days
Primary	Lipid oxidation	Serum malondialdehyde Levels	At 90 days
Primary	Protein oxidation	Serum protein carbonylation Levels	At 90days
Secondary	Handgrip strength	Measures static force in kilograms that the hand can squeeze around a dynamometer	At 60 days
Secondary	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
Secondary	Six-minute walk test	Measures maximum distance in meters, a subject can walk at their normal gait and pace during 6 minutes	6 minutes
Secondary	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
Secondary	Sit-up test	Measures number of times a subject can rise and sit-down in place during 30 seconds	30 seconds
Secondary	EQ-5D questionnaire	Self-administered health index that explores five domains	At 60 days
Secondary	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