Dietary supplement to improve gastrointestinal health and mood in women
Ritual Synbiotic+, a Dietary Supplement
This study is testing if a new dietary supplement can help women aged 25-65 with digestive issues feel better and improve their mood.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 25 Years to 65 Years |
| Sex | Female |
| Sponsor | Colorado State University Academic / other |
| Locations | 1 site (Fort Collins, Colorado) |
| Trial ID | NCT06834984 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of Ritual Synbiotic+, a dietary supplement containing prebiotics, probiotics, and postbiotics, on gastrointestinal health, mood, and behavior in women aged 25-65 with moderate digestive discomfort. Participants will be randomly assigned to receive either the supplement or a placebo in a double-blinded manner. The study will track bowel movements, gastrointestinal symptom severity, and various health markers through questionnaires and clinical assessments over the course of the intervention. The aim is to evaluate improvements in gut health and overall well-being.
Who should consider this trial
Good fit: Ideal candidates are healthy adult women aged 25-65 with a BMI under 30 and moderate gastrointestinal symptoms.
Not a fit: Patients with a BMI over 30 or significant gastrointestinal diseases such as Crohn's or Ulcerative Colitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved gastrointestinal health and enhanced mood for women suffering from digestive issues.
How similar studies have performed: Other studies have shown promising results with similar probiotic and prebiotic interventions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy adult women (age 25-65, with target average age of 50). * BMI \<30. * with moderate gastrointestinal symptoms. * Participants should be willing to follow the study protocol and attend clinic visits. Exclusion Criteria: * less than 25 years of age or greater than 65 years of age. * have a BMI \>30. * taken antibiotics within two months or any probiotic supplements within the past 14 days prior to the start of treatment. * current medications and dietary supplements will be assessed on a case-by- case basis and will result in exclusion if there is the possibility that the drugs or supplements used would influence the endpoints of the study. This would include statins, metformin, NSAIDs, MAO inhibitors, and hormone therapies. * Individuals with current disease diagnosis, including diagnosis of cancer, liver or kidney disease, gastrointestinal diseases, and cardiometabolic disorders (cardiovascular disease, diabetes, etc.) * pregnant and breastfeeding people. * overuse of alcohol as determined on a case-by-case self-reported alcohol use. * if the individual feels they are unable to adhere to the study requirements, which includes consuming capsules, providing stool or blood samples, tracking bowel movements and symptoms, and attending scheduled clinic visits.
Where this trial is running
Fort Collins, Colorado
- Colorado State University Food and Nutrition Clinical Research Laboratory — Fort Collins, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Dr. Tiffany Weir, PhD
- Email: tiffany.weir@colostate.edu
- Phone: (970) 491-4631
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.