Activity of Daily Living, Gut Health, Gut Microbiome, Gut Permeability, Immune Response, Low-grade Chronic Inflammation, Mild Gastrointestinal Symptoms in Healthy Adults, Nutrition, Healthy, Stress
Conditions
Keywords
gut microbiome, gut health, healthy women, perimenopause, pre menopause, middle aged women, fiber, gut brain axis, low grade chronic inflammation, prebiotic
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.
Interventions
DIETARY_SUPPLEMENTfungal fiber
fungal fiber from mycelium
DIETARY_SUPPLEMENTinulin
long chain, degree of polymerization DP\>23
Sponsors
Future Biome SA
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Masking description
data analysts
Eligibility
Sex/Gender
FEMALE
Age
38 Years to 48 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Short Chain Fatty Acids | From enrollment to the end of treatment at 6 weeks | fecal and serum SCFA |
| basal cortisol | From enrollment to the end of treatment at 6 weeks | basal cortisol |
| hs-CRP | From enrollment to the end of treatment at 6 weeks | high sensitivity C Reactive Protein |
Other
| Measure | Time frame | Description |
|---|---|---|
| microbiome metagenomics | from enrollment to the end of treatment at 6 weeks | gut microbiome taxonomy: abundance, diversity |
| microbiome metatranscriptomics | From enrollment to the end of treatment at 6 weeks | expression of gut microbial genes |
Countries
Argentina
Outcome results
None listed