Using spices to improve gut health and heart health
Spices for Cultivating a Healthy Gut Microbiome and Cardiometabolic Profile: the SPICE Study
This study is testing whether adding spices to yogurt can improve gut and heart health in post-menopausal women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 50 Years to 69 Years |
| Sex | Female |
| Sponsor | University of Alabama, Tuscaloosa Academic / other |
| Locations | 1 site (Tuscaloosa, Alabama) |
| Trial ID | NCT06313580 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a food-first synbiotic approach, combining prebiotics and probiotics, on gut microbiota and cardiometabolic health in post-menopausal women. Participants will consume yogurt with added spices or without for four weeks, followed by a washout period, and then switch to the alternative treatment. The study aims to measure changes in gut microbiota and their relationship with systemic metabolic effects, particularly focusing on short chain fatty acids and gut-derived metabolites.
Who should consider this trial
Good fit: Ideal candidates are post-menopausal women aged 50-69 with a BMI between 18.5 and 34.9.
Not a fit: Patients with cardiovascular disease, diabetes, liver disease, cancer, or significant gastrointestinal issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel dietary approach to improve gut health and reduce risks associated with cardiometabolic syndrome.
How similar studies have performed: While the use of spices for health benefits is gaining attention, this specific synbiotic approach is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * post-menopausal women ages 50-69y with a BMI of 18.5 - 34.9 kg/m2 Exclusion Criteria: * Dx - Diagnosis of cardiovascular disease, type 1 or 2 diabetes, liver disease, cancer, endocrine disorders, or inflammatory condition such as rheumatoid arthritis. * GI - History of gastrointestinal surgery, irritable bowel syndrome, intestinal bowel disease, or other gastrointestinal distress such as chronic diarrhea, bulimia, anorexia, or frequent laxative use * Rx or Supplements - Actively taking steroids or antibiotics in the previous two to three months, or currently using tobacco products, \> 10% weight loss or gain in the last 6 months, unwilling to stop taking prebiotic/probiotic or fiber supplements * Dietary - Adherence to a high fiber/polyphenol rich diet, have an allergy, aversion, or intolerance to food and spices provided in this study
Where this trial is running
Tuscaloosa, Alabama
- The University of Alabama — Tuscaloosa, Alabama, United States (Recruiting)
Study contacts
- Study coordinator: Kristi M Crowe-White, PhD, RD
- Email: kcrowe@ches.ua.edu
- Phone: 205-348-6173
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.