An interventional study of Placebo and Flavonoids in Sarcopenia and Frail Elderly Syndrome, sponsored by National Polytechnic Institute, Mexico. Completed. Open to participants aged 55 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-07-13.
Sponsored by National Polytechnic Institute, Mexico · Not applicable, Interventional, and Treatment
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.
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.
1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.
This study's enrollment of 30 is below the median of 60 across 775 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →National Polytechnic Institute, Mexico is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
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Inclusion Criteria:
Non-inclusion criteria:
Beverage without flavonoids
Other: Placebo
Beverage with alkalinized cocoa which eliminates flavonoid content
Dietary Supplement: No Flavonoids
Beverage with a flavonoid rich mixture
Other: Flavonoids
Beverage with no flavonoids
Flavonoids-enriched cacao beverage
Beverage with alkalinized cocoa which eliminates flavonoid content
Blood glucose
Fasting blood level
Time frame: At 90 days
Serum triacylglycerol concentration
Fasting blood level
Time frame: At 90 days
Serum total cholesterol
Fasting blood level
Time frame: At 90 days
Serum HDL cholesterol
Fasting blood level
Time frame: At 90 days
Serum LDL cholesterol
Fasting blood level
Time frame: At 90 days
Lipid oxidation
Serum malondialdehyde Levels
Time frame: At 90 days
Protein oxidation
Serum protein carbonylation Levels
Time frame: At 90days
Handgrip strength
Measures static force in kilograms that the hand can squeeze around a dynamometer
Time frame: At 60 days
Up and go test
Measures time in seconds, a subject can rise and walk a 3-meter line and return to sit down
Time frame: At 60 days
Six-minute walk test
Measures maximum distance in meters, a subject can walk at their normal gait and pace during 6 minutes
Time frame: 6 minutes
Two-minute step in place test
Measures number of times a subject can rise each knee to the hip level during 2 minutes.
Time frame: 2 minutes
Sit-up test
Measures number of times a subject can rise and sit-down in place during 30 seconds
Time frame: 30 seconds
EQ-5D questionnaire
Self-administered health index that explores five domains
Time frame: At 60 days
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.
Time frame: At 60 days
No study locations are listed for this record.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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National Polytechnic Institute, Mexico