An interventional study of Agavins in Dysbiosis, sponsored by National Polytechnic Institute, Mexico. Enrolling by invitation at 1 site in Mexico. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by National Polytechnic Institute, Mexico · Not applicable, Interventional, and Supportive care
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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.
187 studies on the registry are indexed under Dysbiosis; 64 are open to participants now.
This study's planned enrollment of 12 is below the median of 60 across 132 interventional studies indexed under Dysbiosis.
Browse Dysbiosis studies →National Polytechnic Institute, Mexico is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Intervention group that is its own control
Dietary Supplement: Agavins
tomarán 10 g en ayudas diariamente
Also known as: dietetic fiber, agave inulin
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.
Time frame: Before and after agavin supplementation, which lasts 6 weeks
Changes in metabolic stress markers (serum creatine kinase and blood lactate concentrations)
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.
Time frame: Before and after agavin supplementation, which lasts 6 weeks
Change in maximal oxygen consumption (VO₂max; mL/kg/min)
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.
Time frame: before and after the agave treatment, which lasts 6 weeks
Change in body composition
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.
Time frame: before and after the intervention, which lasts six weeks
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified individual participant data underlying the published results will be available. Shared data may include demographic, anthropometric, gut microbiota, short-chain fatty acid, cardiorespiratory fitness, blood biochemical, and statistical analysis data collected before and after the intervention. Personal identifiers will be removed. De-identified data will be available upon reasonable request to the principal investigator for researchers with an approved scientific proposal. Data will be shared after publication of the primary study results.
Supporting information: Clinical study report
Started Jun 2025 (actual). Primary completion is estimated for Feb 2027, 20 months after the start.
Of 71 non-industry interventional studies with no phase under Dysbiosis, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 28. This study's planned 20 months is close to that.
Counting every sponsor, half of 83 studies reached it within 19 months; a quarter within 10 and three quarters within 27.
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Studies of the drug tested here: Blue agave inulin (agave tequilana)
National Polytechnic Institute, Mexico