An interventional study of Yogurt with added Spices and Yogurt without added Spices in Cardiometabolic Syndrome, sponsored by University of Alabama, Tuscaloosa. Recruiting at 1 site in United States. Open to female participants aged 50 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-20.
Sponsored by University of Alabama, Tuscaloosa · Not applicable, Interventional, and Prevention
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.
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).
1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →University of Alabama, Tuscaloosa is the lead sponsor of 39 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Consumption of twice daily yogurt with added spices for four weeks.
Other: Yogurt with added Spices
Consumption of twice daily yogurt without added spices for four weeks.
Other: Yogurt without added Spices
Consumption of twice daily yogurt with added spices for four weeks.
Consumption of twice daily yogurt without added spices for four weeks.
Concentration of fecal short chain fatty acids including acetate, proprionate, and butyrate
Units - uM
Time frame: pre/post each four-week study arm
Concentration of serum leptin
Units - ng/mL
Time frame: pre/post each four-week study arm
Concentration of serum ghrelin (pg/mL)
Units - pg/mL
Time frame: pre/post each four-week study arm
Concentration of serum peptide tyrosine tyrosine (PYY)
Units - pg/mL
Time frame: pre/post each four-week study arm
Plan to share: No
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University of Alabama, Tuscaloosa