Clinical trial NCT03585868: Effects of COcoa Supplement in FRail Elderly Subjects (COFRE)
Official title: Evaluation of the Effects of a COcoa Supplement to Reduce FRailty in the Elderly: COFRE a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Frail Elderly Syndrome
Keywords: flavonoids
Lead sponsor: National Polytechnic Institute, Mexico
Sponsor class: OTHER
First posted: 2018-07-13
Enrollment: 30
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Non-inclusion criteria:

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

Primary outcomes:
measure: Blood glucose
timeFrame: At 90 days
measure: Serum triacylglycerol concentration
timeFrame: At 90 days
measure: Serum total cholesterol
timeFrame: At 90 days
measure: Serum HDL cholesterol
timeFrame: At 90 days
measure: Serum LDL cholesterol
timeFrame: At 90 days
measure: Lipid oxidation
timeFrame: At 90 days
measure: Protein oxidation
timeFrame: At 90days
Secondary outcomes:
measure: Handgrip strength
timeFrame: At 60 days
measure: Up and go test
timeFrame: At 60 days
measure: Six-minute walk test
timeFrame: 6 minutes
measure: Two-minute step in place test
timeFrame: 2 minutes
measure: Sit-up test
timeFrame: 30 seconds
measure: EQ-5D questionnaire
timeFrame: At 60 days
measure: Analog Visual Scale
timeFrame: At 60 days
Other outcomes:
Locations:
Study officials:
References:
citation: 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.