The study use a triple blind, placebo-controlled design enrolling male and female subjects between 30-70 yo to evaluate the effect of daily consumption of a cacao supplement on inflammation, endothelial damage, handgrip strength, fatigue scale and quality of life.
The study use a triple blind, placebo-controlled design enrolling male and female subjects between 30-70 yo distributed homogeneously at random in two groups: the control group (Placebo) and the intervention group (Cacao Flavonoids) both groups affected for 90 days. The variables to consider will be: Interleukins (IL-1b, IL-6), Tumoral Necrosis Factor alpha (TNF-α) and syndecan-1. For physical performance is evaluated the handgrip strength. The investigators also assessed quality of life using the Health Related QoL (EQ-5D) questionnaire, and the numerical fatigue rating scale.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
46
1 capsule every 12h for 90 days
C.E. Indianilla
Mexico City, Mexico City, Mexico
Interleukin-1b
Plasmatic concentration
Time frame: At 0 and 90 day
Interleukin-6
Plasmatic concentration
Time frame: At 0 and 90 day
TNF-alpha
Plasmatic concentration
Time frame: At 0 and 90 day
Syndecan-1
Plasmatic concentration
Time frame: At 0 and 90 day
EQ-5D questionnaire
Self-administered health index that explores five domains
Time frame: At 0 and 90 day
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 0 and 90 day
Numerical fatigue rating scale
fatigue rating scale graded 0 (best) to 100 (worst)
Time frame: At 0 and 90 day
Handgrip strength
Measures static force in kilograms that the hand can squeeze around a dynamometer
Time frame: At 0 and 90 day
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