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

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ClinicalTrials.gov Identifier: NCT03585868
Recruitment Status : Completed
First Posted : July 13, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Guillermo Ceballos Reyes, National Polytechnic Institute, Mexico

Tracking Information
First Submitted Date  ICMJE May 16, 2018
First Posted Date  ICMJE July 13, 2018
Last Update Posted Date July 13, 2018
Actual Study Start Date  ICMJE January 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2018)
  • Blood glucose [ Time Frame: At 90 days ]
    Fasting blood level
  • Serum triacylglycerol concentration [ Time Frame: At 90 days ]
    Fasting blood level
  • Serum total cholesterol [ Time Frame: At 90 days ]
    Fasting blood level
  • Serum HDL cholesterol [ Time Frame: At 90 days ]
    Fasting blood level
  • Serum LDL cholesterol [ Time Frame: At 90 days ]
    Fasting blood level
  • Lipid oxidation [ Time Frame: At 90 days ]
    Serum malondialdehyde Levels
  • Protein oxidation [ Time Frame: At 90days ]
    Serum protein carbonylation Levels
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2018)
  • Handgrip strength [ Time Frame: At 60 days ]
    Measures static force in kilograms that the hand can squeeze around a dynamometer
  • Up and go test [ Time Frame: At 60 days ]
    Measures time in seconds, a subject can rise and walk a 3-meter line and return to sit down
  • Six-minute walk test [ Time Frame: 6 minutes ]
    Measures maximum distance in meters, a subject can walk at their normal gait and pace during 6 minutes
  • Two-minute step in place test [ Time Frame: 2 minutes ]
    Measures number of times a subject can rise each knee to the hip level during 2 minutes.
  • Sit-up test [ Time Frame: 30 seconds ]
    Measures number of times a subject can rise and sit-down in place during 30 seconds
  • EQ-5D questionnaire [ Time Frame: At 60 days ]
    Self-administered health index that explores five domains
  • Analog Visual Scale [ Time Frame: At 60 days ]
    Use of a Analog Visual Scale to measure the quality of life, graded 0 (worst) to 100 (best) for the perception of wellbeing.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of COcoa Supplement in FRail Elderly Subjects (COFRE)
Official Title  ICMJE Evaluation of the Effects of a COcoa Supplement to Reduce FRailty in the Elderly: COFRE a Randomized Clinical Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Sarcopenia
  • Frail Elderly Syndrome
Intervention  ICMJE
  • Other: Placebo
    Beverage with no flavonoids
  • Other: Flavonoids
    Flavonoids-enriched cacao beverage
  • Dietary Supplement: No Flavonoids
    Beverage with alkalinized cocoa which eliminates flavonoid content
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Beverage without flavonoids
    Intervention: Other: Placebo
  • Sham Comparator: No Flavonoids
    Beverage with alkalinized cocoa which eliminates flavonoid content
    Intervention: Dietary Supplement: No Flavonoids
  • Experimental: Flavonoids
    Beverage with a flavonoid rich mixture
    Intervention: Other: Flavonoids
Publications * Munguia L, Rubio-Gayosso I, Ramirez-Sanchez I, Ortiz A, Hidalgoa 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 May 6. pii: glz107. doi: 10.1093/gerona/glz107. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 12, 2018)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03585868
Other Study ID Numbers  ICMJE COFRE-LIICM
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Guillermo Ceballos Reyes, National Polytechnic Institute, Mexico
Study Sponsor  ICMJE National Polytechnic Institute, Mexico
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Polytechnic Institute, Mexico
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP