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Enrolling by invitation

NCT Number: NCT07828093

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

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.

Enrolling by invitation

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Key information

Conditions

Dysbiosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Desarrollo de Productos Bióticos

Yautepec, Morelos, 62739, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • athletes in any sport, metabolically healthy.

Exclusion criteria

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

Treatment and study plan

Agavins

Dietary Supplement

tomarán 10 g en ayudas diariamente

Other names: dietetic fiber, agave inulin

Primary outcomes

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

    Time frame: Before and after agavin supplementation, which lasts 6 weeks

    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.

Secondary outcomes

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

    Time frame: Before and after agavin supplementation, which lasts 6 weeks

    Metabolic stress will be assessed by measuring serum creatine kinase and blood lactate concentrations at baseline and after the intervention. Creatine kinase will be quantified in serum samples, and blood lactate concentration will be determined using the Accutrend Plus analyzer. Results will be reported as concentrations and changes from baseline.

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

    Time frame: before and after the agave treatment, which lasts 6 weeks

    Maximal oxygen consumption (VO₂max) will be assessed using a CardioCoach Pro metabolic analyzer during a graded exercise test on a treadmill. VO₂max will be reported in mL/kg/min at baseline and after the intervention, and changes from baseline will be calculated.

  3. Change in body composition

    Time frame: before and after the intervention, which lasts six weeks

    Changes in body composition will be assessed at baseline and after the intervention. Body weight (kg), body mass index (BMI; kg/m²), body fat percentage (%), and skeletal muscle mass percentage (%) will be measured and reported. Changes from baseline will be calculated for each body composition parameter.

Interested in participating?

Enrolling by invitation

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

National Polytechnic Institute, Mexico

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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