Spices for Cultivating a Healthy Gut Microbiome and Cardiometabolic Profile

University of Alabama, Tuscaloosa

Status: Enrolling

Conditions: Cardiometabolic Syndrome

Treatments: Other: Yogurt with added Spices; Other: Yogurt without added Spices

Study type: Interventional

Funder types: Other

Identifiers

NCT06313580

22-1055

Details and patient eligibility

About

Among food products receiving attention for prebiotic functionality, spices represent a flavorful vehicle for cultivating a healthy gut microbiota. As the required doses of spice-derived polyphenols to elicit prebiotic and systemic metabolic effects are not well-characterized, additional research is warranted. Thus, the investigators propose to use a food-first synbiotic (prebiotic + probiotic) approach to examine alterations in the gut microbiota pre- and post-intervention/placebo and their relationship with systemic cardiometabolic effects mediated by short chain fatty acids (SCFA) and gut-derived metabolites.

Full description

Study will be conducted as a single blind, randomized crossover design with a 4-week arm (placebo or control) followed by a 2-week washout period and another 4-week arm (placebo or control).

Enrollment: 30 estimated patients

Sex: Female

Ages: 50 to 69 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

30 participants in 2 patient groups

Intervention Arm - Yogurt with added Spices

Experimental group

Description:

Consumption of twice daily yogurt with added spices for four weeks.

Treatment:

Other: Yogurt with added Spices

Sham Arm - Yogurt without added Spices

Sham Comparator group

Description:

Consumption of twice daily yogurt without added spices for four weeks.

Treatment:

Other: Yogurt without added Spices