Fungal Fiber for Gut Health

Launched by FUTURE BIOME SA · May 5, 2024

Keywords

ClinConnect Summary

The "Fungal Fiber for Gut Health" trial is studying how different types of fiber—plant-based and fungi-based—can affect gut health in healthy women aged 37 to 48. The researchers want to see if these fibers can improve gut function, which includes how the immune system works, how we handle stress and emotions, and how our gut bacteria behave. To join the study, participants need to be in good health but have experienced mild gastrointestinal symptoms like bloating or discomfort after eating in the past week. They should also have a daily fiber intake of less than 20 grams and a body mass index (BMI) between 18.5 and 29.9.

Participants will be asked to take capsules of either type of fiber and follow specific guidelines during the study. It’s important for them to be available for the trial and to avoid certain medications or supplements that could interfere with the results. This study is currently recruiting participants living in the Buenos Aires area, and anyone interested in improving their gut health might find this trial beneficial.

Gender

FEMALE

Eligibility 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.