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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

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.

Condition or disease Intervention/treatment Phase
Sarcopenia Frail Elderly Syndrome Other: Placebo Other: Flavonoids Dietary Supplement: No Flavonoids Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Effects of a COcoa Supplement to Reduce FRailty in the Elderly: COFRE a Randomized Clinical Trial
Actual Study Start Date : January 2017
Actual Primary Completion Date : October 2017
Actual Study Completion Date : December 2017

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




Primary Outcome Measures :
  1. Blood glucose [ Time Frame: At 90 days ]
    Fasting blood level

  2. Serum triacylglycerol concentration [ Time Frame: At 90 days ]
    Fasting blood level

  3. Serum total cholesterol [ Time Frame: At 90 days ]
    Fasting blood level

  4. Serum HDL cholesterol [ Time Frame: At 90 days ]
    Fasting blood level

  5. Serum LDL cholesterol [ Time Frame: At 90 days ]
    Fasting blood level

  6. Lipid oxidation [ Time Frame: At 90 days ]
    Serum malondialdehyde Levels

  7. Protein oxidation [ Time Frame: At 90days ]
    Serum protein carbonylation Levels


Secondary Outcome Measures :
  1. Handgrip strength [ Time Frame: At 60 days ]
    Measures static force in kilograms that the hand can squeeze around a dynamometer

  2. 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

  3. 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

  4. 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.

  5. Sit-up test [ Time Frame: 30 seconds ]
    Measures number of times a subject can rise and sit-down in place during 30 seconds

  6. EQ-5D questionnaire [ Time Frame: At 60 days ]
    Self-administered health index that explores five domains

  7. 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.



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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Guillermo Ceballos Reyes, Professor, National Polytechnic Institute, Mexico
ClinicalTrials.gov Identifier: NCT03585868     History of Changes
Other Study ID Numbers: COFRE-LIICM
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Guillermo Ceballos Reyes, National Polytechnic Institute, Mexico:
flavonoids

Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms