Ireland
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Recruiting Not applicable

Postprandial Glucose Levels, Gut Microbiota and Supplementation With Functional Foods in Adults

NCT05723913 · tracked via the Priya Life Science Mexico tracker
Phase
Not applicable
Started
2023-06-07
Last updated
2025-06-18

Condition(s) studied

HealthyNutritional and Metabolic Diseases

Investigational drug(s) / intervention(s)

Dietary Supplement: A package containing a mix of functional foods

Dietary Supplement: A package containing a mix of functional foods: Participants will be provided with a nutritional strategy based on functional foods to use over the 2 week trial. These will be nopal, chía seeds, inulin, soy protein, agave extract and genistein.

Study summary

This is a clinical study with participants over 18 years of age that meet the selection criteria. This will be 42-day study divided into three phases of 14 days each: 14 days without intervention, 14 days with intervention with functional foods and 14 days without intervention again. With the objective of assess the changes in the postprandial glycemic responses through the gut microbiota and urine metabolites.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Male and female * Adults between 18 and 60 years of age. * The signing of the informed consent. Exclusion Criteria: * Patients with any type of diabetes. * Patients with high blood pressure. * Patients with acquired diseases secondarily producing obesity and diabetes. * Patients who have suffered a cardiovascular event. * Patients with gastrointestinal diseases. * Weight loss \> 3 kg in the last 3 months. * Catabolic diseases such as cancer and acquired immunodeficiency syndrome. * Pregnancy status. * Drug treatment: * Antihypertensive drugs or treatment (thiacycline, loop or potassium-sparing diuretics, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, alpha blockers, calcium antagonists, beta blockers). * Treatment with hypoglycemic agents (sulfonylureas, biguanides, incretins) or insulin and antidiabetic drugs. * Treatment with statins, fibrates or other drugs to control dyslipidemia. * Use of antibiotics in the three months prior to the study. * Use of steroid drugs, chemotherapy, immunosuppressants, or radiation therapy. * Anorexigenic or that accelerate weight loss such as sibutramine or orlistat. * Supplements with any of the functional foods used in the study. * Probiotic, prebiotic or symbiotic supplements.

Primary outcome measure(s)

  • Changes in postprandial glucose responses — 6 weeks
    Postprandial glucose concentrations (mmol/L). The incremental area under the curve will be calculated and expressed as mmol\*minutes/litre.
  • Changes in diversity analysis of intestinal microbiota with and without intervention with functional foods — 6 weeks
    Based on the gene and species composition of each sample, the Chao1 and Shannon indexes, as well as the observed operational taxonomic units, will be calculated in order to identify the differences in gene and species diversity for each group

Trial sites (1)

FacilityCityRegionStatus
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Mexico City Mexico City Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05723913 on ClinicalTrials.gov ↗ ← All trials in Mexico