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Effect of an Polyphenolic Beverage in Healthy Volunteers
Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Summary
Currently, there are different strategies to prevent the effect of beverages and foods on blood glucose levels after ingestion. In this sense, polyphenols are a promising field; these compounds are secondary metabolites produced by plants, vegetables, and fruits; of these compounds, gallic acid, quercetin, and kaempferol stand out for their antihyperglycemic characteristics through a) complex formation, b) enzymatic inhibition, c) affecting transport and, d) stimulation of the secretion of intestinal satiety hormones. Vachellia farnesiana (VF) is a shrub distributed in arid, semi-arid, and tropical regions of Mexico and the world. The polyphenols of the fruits of VF in pre-clinical studies by this research group have shown important antioxidant activity and antihyperglycemic effects. The present proposal aims to evaluate the effect of the polyphenolic extract of Vachellia farnesiana on glycemic response and to monitor liver and renal function tests as a safety control in healthy volunteers through developing a Phase I clinical study.
Official title: Effect of Polyphenolic Extract of Vachellia Farnesiana on Glycemic Response and Safety in Healthy Volunteers.
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2022-04-06
Completion Date
2027-11-30
Last Updated
2025-05-13
Healthy Volunteers
Yes
Conditions
Interventions
Polyphenolic beverage from extract of Vachellia farnesiana
During Visit 2. A single infusion of the polyphenolic extract was administered orally. The dose (1.2 mg/kg body weight) of lyophilized extract, which was diluted in water, was calculated considering each participant's weight.