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Fungal Fiber for Gut Health

Fungal Fiber for Gut Health

Recruiting
38-48 years
Female
Phase N/A

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Overview

This study compares effects of plant based fiber vs fungi based fiber on clinical outcomes related to gut function (immunity, emotions, stress) and explores the role of gut microbiome structure and function on individual responses.

Eligibility

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.

Study details
    Mild Gastrointestinal Symptoms in Healthy Adults
    Low-grade Chronic Inflammation
    Stress
    Gut Health
    Gut Permeability
    Gut Microbiome
    Immune Response
    Activity of Daily Living
    Nutrition
    Healthy

NCT06404749

Future Biome SA

14 May 2024

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