Fungal Fiber for Gut Health

Not Applicable

Recruiting

• Conditions: Low-grade Chronic Inflammation; Stress; Gut Permeability; Gut Microbiome; Mild Gastrointestinal Symptoms in Healthy Adults; Gut Health; Activity of Daily Living; Immune Response; Nutrition, Healthy
• Interventions: Dietary Supplement: fungal fiber; Dietary Supplement: inulin

• Registration Number: NCT06404749
• Lead Sponsor: Future Biome SA

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-05-03
• Study First Submitted: 2024-05-05
• Study First Submitted QC: 2024-05-05
• Last Update Submitted: 2024-05-07
• Study First Posted: 2024-05-08
• Last Update Posted: 2024-05-09
• Primary Completion: 2025-12
• Study Completion: 2026-05-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
FB01	fungal fiber	fungal fiber, 150 mg/day, oral capsules, 2 weeks
inulin	inulin	inulin, 3 g/day, oral capsules, 2 weeks

Primary Outcome Measures

Name	Time	Method
GastroIntestinal Quality of Life Index	From enrollment to the end of treatment at 6 weeks	GastroIntestinal Quality of Life Index (GIQLI), self assessed questionnaire, minimum score 0 (low quality), maximum score 144 (high quality)

Secondary Outcome Measures

Name	Time	Method
basal cortisol	From enrollment to the end of treatment at 6 weeks	basal cortisol
Bristol	From the enrollment to the end of treatment at 6 weeks	Bristol scale and frequency chart. Frequency and consistence of feces, self assessed questionnaire. Range 1 to 7. Optimal value: 4. Values 1-3: different levels of constipation. Values 6-7: different levels of diarrhea
Wisconsin Upper Respiratory Symptom Survey	From enrollment to the end of treatment at 6 weeks	Wisconsin Upper Respiratory Symptom Survey (WURSS41) scale, self assessed questionnaire, range 0 (desired) to 301 (undesired)
Positive and Negative Affect Schedule	From enrollment to the end of treatment at 6 weeks	PANAS, self assessed questionnaire. Range from 10 (lowest) to 50 (highest) for both positive and negative scale
hs-CRP	From enrollment to the end of treatment at 6 weeks	high sensitivity C Reactive Protein
Short Chain Fatty Acids	From enrollment to the end of treatment at 6 weeks	fecal and serum SCFA
Work Productivity and Activity Impairment	From enrollment to the end of treatment at 6 weeks	WPAI, self assessed questionnaire, range 0 (desired) to 100 (undesired)
calprotectin	From enrollment to the end of treatment at 6 weeks	fecal

Trial Locations

Locations (1)

Consultorios Del Dr Jorge Eduardo Tartaglione; 🇦🇷 Ciudad Autonoma de Buenos Aires, Caba, Argentina