Fungal Fiber for Gut Health (FUN4GUT)

Future Biome SA

Status: Enrolling

Conditions: Low-grade Chronic Inflammation; Immune Response; Gut Microbiome; Nutrition, Healthy; Activity of Daily Living; Gut Permeability; Gut Health; Mild Gastrointestinal Symptoms in Healthy Adults; Stress

Treatments: Dietary Supplement: inulin; Dietary Supplement: fungal fiber

Study type: Interventional

Funder types: Industry

Identifiers

NCT06404749

FUN4GUT01

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 38 to 48 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups

FB01

Experimental group

Description:

fungal fiber, 150 mg/day, oral capsules, 2 weeks

Treatment:

Dietary Supplement: fungal fiber

inulin

Active Comparator group

Description:

inulin, 3 g/day, oral capsules, 2 weeks

Treatment:

Dietary Supplement: inulin