DysbiosisNCT07828093
Effect of Agave Consumption on Performance and Gut Microbiota in Adults Undergoing Physical Training
A study testing Agavins in people with Dysbiosis, run by National Polytechnic Institute, Mexico at 1 site in Mexico.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Dysbiosis
- What is being tested?
- Agavins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteMexico
- Study dates
- 6 Jun 2025to 11 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- athletes in any sport, metabolically healthy.
Who cannot join
- intestinal diseases, recreational athletes, people undergoing antibiotic treatment, people undergoing treatment with probiotics or prebiotics.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
Centro de Desarrollo de Productos Bióticos
Yautepec, Morelos, 62739
About this study
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.
Read more
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
- Being tested
- Agavins
- Keywords
- sports, microbiota, dietetic fiber, agavins, athlete
- Medical subject headings
- Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AgavinsDietary supplement
Also called dietetic fiber, agave inulin
tomarán 10 g en ayudas diariamente
| Study group | Role | What they receive |
|---|---|---|
| agavins | Experimental | Intervention group that is its own control Receives: Dietary Supplement: Agavins |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and after agavin supplementation, which lasts 6 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: before and after the intervention, which lasts six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start6 Jun 2025
- Primary completion11 Feb 2027 (estimated)
- Study completion11 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysbiosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Polytechnic Institute, Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AMALINALI PORTILLO AYALA, National Polytechnic Institute, Mexico
- Investigators
- Perla Osorio, SNI II, Study director, Centro de Desarrollo de Productos BióticosBrenda H Camacho, Díaz, Study director, Centro de Desarrollo de Productos Bióticos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828093
- Sponsor's protocol ID
- CEI CEPROBI-2025-3
- Status last verified
- Sep 2026
- First submitted
- 14 Aug 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Agave Consumption on Performance and Gut Microbiota in Adults Undergoing Physical Training
- ClinicalTrials.gov ID
- NCT07828093
- Acronym / sponsor ID
- CEI CEPROBI-2025-3
- Conditions
- Dysbiosis
- Keywords
- sports, microbiota, dietetic fiber, agavins, athlete
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- National Polytechnic Institute, MexicoUniversity, hospital or other
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- 11 Feb 2027 (estimated)
- Study completion
- 11 Feb 2027 (estimated)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| agavins | Experimental | Dietary Supplement: AgavinsIntervention group that is its own control |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- athletes in any sport, metabolically healthy.
Key exclusion criteria (1 listed)
- intestinal diseases, recreational athletes, people undergoing antibiotic treatment, people undergoing treatment with probiotics or prebiotics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AgavinsAlso: dietetic fiber, agave inulintomarán 10 g en ayudas diariamente | Dietary supplement | agavins |
Primary outcome
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.
3 secondary outcomes
Changes in metabolic stress markers (serum creatine kinase and blood lactate concentrations)
Time frame: Before and after agavin supplementation, which lasts 6 weeks
Change in maximal oxygen consumption (VO₂max; mL/kg/min)
Time frame: before and after the agave treatment, which lasts 6 weeks
Change in body composition
Time frame: before and after the intervention, which lasts six weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: 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.
Related trials for Dysbiosis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Enrolling by invitationPhase 2
Herbal Supplement (Biocidin REMOVE) for Bacterial Overgrowth in Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Small Intestinal Bacterial Overgrowth Syndrome (SIBO)
RecruitingObservational study
Effects Of Periodontal Therapy In Patients With Inflammatory Bowel Disease
Periodontal Diseases, IBD
Recruiting
Effect of a Probiotic or Postbiotic on Gut Microbiome During Antibiotic Treatment
Microbiome
RecruitingObservational study
Metabolic and Functional Study of γδ T Cells in Critically Ill Patients
Sepsis, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Perla Osorio, SNI II study director
Centro de Desarrollo de Productos Bióticos
Brenda H Camacho, Díaz study director
Centro de Desarrollo de Productos Bióticos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Agavins in people with Dysbiosis, run by National Polytechnic Institute, Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.