Comparing plant-based and fungal fiber for gut health
Fungal Fiber for Gut Health
This study tests whether fungal fiber or plant-based fiber can improve gut health and well-being in healthy women aged 37 to 48.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 38 Years to 48 Years |
| Sex | Female |
| Sponsor | Future Biome SA Industry-sponsored |
| Locations | 1 site (Ciudad Autonoma de Buenos Aires, Caba) |
| Trial ID | NCT06404749 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of fungal fiber versus plant-based fiber on gut function and related clinical outcomes in healthy women aged 37 to 48. It focuses on how these fibers influence gut microbiome structure and function, as well as their impact on gastrointestinal symptoms, stress, and emotional well-being. Participants will be monitored for their gastrointestinal symptoms and overall gut health during the intervention period.
Who should consider this trial
Good fit: Ideal candidates are healthy women aged 37 to 48 who experience mild gastrointestinal symptoms and consume less than 20g of fiber per day.
Not a fit: Patients with chronic immune, metabolic, or gastrointestinal diseases, or those who have had gastrointestinal surgery, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary fiber options that improve gut health and reduce gastrointestinal symptoms.
How similar studies have performed: While the specific comparison of fungal fiber to plant-based fiber is novel, studies on dietary fibers and gut health have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Provision of a signed and dated informed consent form 2. Declared willingness to comply with all study procedures and availability during the study. 3. Female, \>37 years, ≤48 years 4. Healthy volunteers who have experienced at least one of the following Gastrointestinal symptoms in the last week: abdominal pain, full stomach, bloating, accidental leakage of intestinal gas, loud belching, bowel movements more frequent than usual, discomfort when eating, with a GIQLI score \<121 5. Fiber intake \<20g/day according to R24 6. 18.5 ≤ BMI ≤ 29.9 7. Volunteers permanently living in the Buenos Aires Metropolitan Area for at least 6 months prior to the intervention. 8. Ability to take oral capsules and willingness to comply with intervention regimen of the study. 9. Agreement to comply with lifestyle considerations during the study. Exclusion Criteria: 1. History of chronic immune, metabolic or gastrointestinal diseases. 2. History of gastrointestinal surgery. 3. Acute illness within one week prior to screening. 4. Treatment with oral or systemic antibiotics within 3 months prior to screening. 5. Hospitalization within 3 months prior to screening. 6. Consumption of laxatives or antidiarrheals, antispasmodic agents, antacids, anti-inflammatories within three days prior to screening. 7. Current intake of fiber or prebiotics as a supplement, or probiotics as a supplement. 8. Vegan, vegetarian or on a special diet. 9. Pregnancy or breastfeeding. 10. Menopause (absence of menstruation for 12 consecutive months) or postmenopause. 11. Known allergic reactions to components of the study interventions: inulin, beta-glucan, mushrooms, magnesium stearate, microcrystalline cellulose, hydroxypropylmethylcellulose. 12. Treatment with another investigational drug or other intervention in the last 6 months. 13. Receives pharmacological intervention for the treatment of a disease 14. Any disorder that, in the opinion of the investigator, could jeopardize safety of the participant.
Where this trial is running
Ciudad Autonoma de Buenos Aires, Caba
- Consultorios Del Dr Jorge Eduardo Tartaglione — Ciudad Autonoma de Buenos Aires, Caba, Argentina (Recruiting)
Study contacts
- Principal investigator: Javier Tartaglione
- Study coordinator: Javier Tartaglione
- Email: Javier@tartaglione.com.ar
- Phone: 541148134563
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.