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Effect of an Polyphenolic Beverage in Healthy Volunteers

NCT05802472 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-13

No results posted yet for this study

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.

Conditions

  • Healthy
  • Safety Issues

Interventions

OTHER

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.

Sponsors & Collaborators

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-06
Primary Completion
2025-10-30
Completion
2027-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05802472 on ClinicalTrials.gov