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
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2017
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedFirst Submitted
Initial submission to the registry
May 16, 2018
CompletedFirst Posted
Study publicly available on registry
July 13, 2018
CompletedJuly 13, 2018
July 1, 2018
9 months
May 16, 2018
July 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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 Outcomes (7)
Handgrip strength
At 60 days
Up and go test
At 60 days
Six-minute walk test
6 minutes
Two-minute step in place test
2 minutes
Sit-up test
30 seconds
- +2 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATORBeverage without flavonoids
No Flavonoids
SHAM COMPARATORBeverage with alkalinized cocoa which eliminates flavonoid content
Flavonoids
EXPERIMENTALBeverage with a flavonoid rich mixture
Interventions
Beverage with alkalinized cocoa which eliminates flavonoid content
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 31056655DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 16, 2018
First Posted
July 13, 2018
Study Start
January 1, 2017
Primary Completion
October 1, 2017
Study Completion
December 1, 2017
Last Updated
July 13, 2018
Record last verified: 2018-07