Stress Clinical Trial
— FUN4GUTOfficial title:
Fungal Fiber for Gut Health
NCT number | NCT06404749 |
Other study ID # | FUN4GUT01 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 3, 2024 |
Est. completion date | May 3, 2026 |
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | May 3, 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 38 Years to 48 Years |
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. |
Country | Name | City | State |
---|---|---|---|
Argentina | Consultorios Del Dr Jorge Eduardo Tartaglione | Ciudad Autonoma de Buenos Aires | Caba |
Lead Sponsor | Collaborator |
---|---|
Future Biome SA |
Argentina,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | microbiome metagenomics | gut microbiome taxonomy: abundance, diversity | from enrollment to the end of treatment at 6 weeks | |
Other | microbiome metatranscriptomics | expression of gut microbial genes | From enrollment to the end of treatment at 6 weeks | |
Primary | GastroIntestinal Quality of Life Index | GastroIntestinal Quality of Life Index (GIQLI), self assessed questionnaire, minimum score 0 (low quality), maximum score 144 (high quality) | From enrollment to the end of treatment at 6 weeks | |
Secondary | Bristol | 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 | From the enrollment to the end of treatment at 6 weeks | |
Secondary | Wisconsin Upper Respiratory Symptom Survey | Wisconsin Upper Respiratory Symptom Survey (WURSS41) scale, self assessed questionnaire, range 0 (desired) to 301 (undesired) | From enrollment to the end of treatment at 6 weeks | |
Secondary | Positive and Negative Affect Schedule | PANAS, self assessed questionnaire. Range from 10 (lowest) to 50 (highest) for both positive and negative scale | From enrollment to the end of treatment at 6 weeks | |
Secondary | Work Productivity and Activity Impairment | WPAI, self assessed questionnaire, range 0 (desired) to 100 (undesired) | From enrollment to the end of treatment at 6 weeks | |
Secondary | basal cortisol | basal cortisol | From enrollment to the end of treatment at 6 weeks | |
Secondary | hs-CRP | high sensitivity C Reactive Protein | From enrollment to the end of treatment at 6 weeks | |
Secondary | calprotectin | fecal | From enrollment to the end of treatment at 6 weeks | |
Secondary | Short Chain Fatty Acids | fecal and serum SCFA | From enrollment to the end of treatment at 6 weeks |
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