Effect of Agave Consumption on Performance and Gut Microbiota in Adults Undergoing Physical Training

NCT07828093 | Enrolling By Invitation

• 1 other identifier: CEI CEPROBI-2025-3
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to analyze changes in the gut microbiota of healthy adult athletes, both men and women, before and after supplementation with a dietary fiber (agavins). Each participant will be their own control, so the design will allow us to identify whether the intervention generates changes in bacterial composition and whether these changes are related to variations in physical performance. The study will determine changes in the gut microbiota, athletic performance, and markers of metabolic stress such as lactate and creatine kinase. Volunteers will be required to take 10g of agavins in warm water for 6 weeks. The gut microbiota will be evaluated through a stool sample, while athletic performance will be measured through direct calorimetry, determining VO2max. Lactate will be determined by finger prick using Accutrend Plus equipment, while creatine kinase will be measured using a blood sample taken by staff from the biomarker measurement laboratory of the Department of Nutrition and Functional Foods.

Conditions

Dysbiosis

Keywords

sports; microbiota; dietetic fiber; agavins; athlete

Outcome Measures

Primary Outcomes (1)

• Changes in the relative abundance of gut microbiota bacterial taxa determined by multiplex digital PCR

  The relative abundance of selected gut microbiota bacterial taxa will be determined from fresh fecal samples collected at baseline and after 6 weeks of supplementation using multiplex digital PCR and reported as percentages of the total bacterial population.

  Before and after agavin supplementation, which lasts 6 weeks

Secondary Outcomes (3)

• Changes in metabolic stress markers (serum creatine kinase and blood lactate concentrations)

  Before and after agavin supplementation, which lasts 6 weeks

• Change in maximal oxygen consumption (VO₂max; mL/kg/min)

  before and after the agave treatment, which lasts 6 weeks

• Change in body composition

  before and after the intervention, which lasts six weeks

Study Arms (1)

agavins

EXPERIMENTAL

Intervention group that is its own control

Dietary Supplement: Agavins

Interventions

Agavins DIETARY_SUPPLEMENT

tomarán 10 g en ayudas diariamente

Also known as: dietetic fiber, agave inulin

agavins

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• athletes in any sport, metabolically healthy.

You may not qualify if:

• intestinal diseases, recreational athletes, people undergoing antibiotic treatment, people undergoing treatment with probiotics or prebiotics.

Sponsors & Collaborators

• National Polytechnic Institute, Mexico: lead

Study Sites (1)

Centro de Desarrollo de Productos Bióticos

Yautepec, Morelos, 62739, Mexico

Location

MeSH Terms

Conditions

Dysbiosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Perla Osorio, SNI II

  Centro de Desarrollo de Productos Bióticos

  STUDY DIRECTOR

• Brenda H Camacho, Díaz

  Centro de Desarrollo de Productos Bióticos

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: phD student

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: September 18, 2026
• Study Start: June 6, 2025
• Primary Completion (Estimated): February 11, 2027
• Study Completion (Estimated): February 11, 2027
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

ME (1)