Fungal Fiber for Gut Health

TerminadoClinicalTrials.gov

ID: NCT06404749Tipo: INTERVENTIONALInicio: 3 de may de 2024Fin estimado: 24 de dic de 2024

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 38 YearsEdad máxima: 48 YearsSexo: FEMALE

Criterios de inclusión

Provision of a signed and dated informed consent form
Declared willingness to comply with all study procedures and availability during the study.
Female, \>37 years, ≤48 years
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
Fiber intake \<20g/day according to R24
≤ BMI ≤ 29.9
Volunteers permanently living in the Buenos Aires Metropolitan Area for at least 6 months prior to the intervention.
Ability to take oral capsules and willingness to comply with intervention regimen of the study.
Agreement to comply with lifestyle considerations during the study.

Criterios de exclusión

History of chronic immune, metabolic or gastrointestinal diseases.
History of gastrointestinal surgery.
Acute illness within one week prior to screening.
Treatment with oral or systemic antibiotics within 3 months prior to screening.
Hospitalization within 3 months prior to screening.
Consumption of laxatives or antidiarrheals, antispasmodic agents, antacids, anti-inflammatories within three days prior to screening.
Current intake of fiber or prebiotics as a supplement, or probiotics as a supplement.
Vegan, vegetarian or on a special diet.
Pregnancy or breastfeeding.
Menopause (absence of menstruation for 12 consecutive months) or postmenopause.
Known allergic reactions to components of the study interventions: inulin, beta-glucan, mushrooms, magnesium stearate, microcrystalline cellulose, hydroxypropylmethylcellulose.
Treatment with another investigational drug or other intervention in the last 6 months.
Receives pharmacological intervention for the treatment of a disease
Any disorder that, in the opinion of the investigator, could jeopardize safety of the participant.

Intervenciones

dietary_supplement

fungal fiber

fungal fiber from mycelium

dietary_supplement

inulin

long chain, degree of polymerization DP\>23

Ubicaciones

Consultorios Del Dr Jorge Eduardo Tartaglione

Buenos Aires, Buenos Aires F.D., Argentina

Patrocinadores

PrincipalFuture Biome SA

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Fungal Fiber for Gut Health | EligiMed