NCT06313580

Spices for Cultivating a Healthy Gut Microbiome and Cardiometabolic Profile

Spices for Cultivating a Healthy Gut Microbiome and Cardiometabolic Profile: the SPICE Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Alabama, Tuscaloosa · Academic / Other
• Sex: Female
• Age: 50 Years – 69 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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).

Conditions

• Cardiometabolic Syndrome

Interventions

Type	Name	Description
OTHER	Yogurt with added Spices	Consumption of twice daily yogurt with added spices for four weeks.
OTHER	Yogurt without added Spices	Consumption of twice daily yogurt without added spices for four weeks.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-12-01
• Completion: 2025-06-01
• First posted: 2024-03-15
• Last updated: 2024-03-20

Locations

1 site across 1 country: United States