None listed
Conditions
Brief summary
In adults with metabolic syndrome the study will compare the efficacy of a grape skin extract combined with non-pharmacological treatment (diet/exercise orientation) in insulin resistance (measured using the homeostasis model assessment of insulin resistance [HOMA-IR] index), as compared to placebo plus non-pharmacological treatment (diet/exercise orientation). The hypothesis will consider the superiority of the grape skin extract therapy.
Interventions
Two arms:
1)grape skin extract 500 micrograms, three times a day, for 24 weeks; tablet
2)placebo (microcellulose) 500 micrograms, three times a day, for 24 weeks; tablet
Both arms will have non-pharmacological treatment (specialised diet taken daily for 24 weeks/exercise orientation: regular light/moderate-intensity physical activity at least 30 minutes daily, 4-7 days/week) according to the First Brazilian Guideline on the Diagnosis and Treatment of The metabolic Syndrome- Brazilian Society
Two arms: 1)grape skin extract 500 micrograms, three times a day, for 24 weeks; tablet 2)placebo (microcellulose) 500 micrograms, three times a day, for 24 weeks; tablet Both arms will have non-pharmacological treatment (specialised diet taken daily for 24 weeks/exercise orientation: regular light/moderate-intensity physical activity at least 30 minutes daily, 4-7 days/week) according to the First Brazilian Guideline on the Diagnosis and Treatment of The metabolic Syndrome- Brazilian Society of Cardiology
Sponsors
Ache Laboratories
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
diagnosis of metabolic syndrome homeostasis model assessment of insulin resistance [HOMA-IR] >2,7
Exclusion criteria
hypertension (stages 2 and 3) diabetes
Outcome results
None listed