Spices for Cultivating a Healthy Gut Microbiome and Cardiometabolic Profile

Cardiometabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06313580
• Other study ID #: 22-1055
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: University of Alabama, Tuscaloosa
• Contact: Kristi M Crowe-White, PhD, RD
• Phone: 205-348-6173
• Email: kcrowe[@]ches.ua.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiometabolic Syndrome
• Metabolic Syndrome

Intervention

Other:
• Yogurt with added Spices
Consumption of twice daily yogurt with added spices for four weeks.
• Yogurt without added Spices
Consumption of twice daily yogurt without added spices for four weeks.

Locations

Country	Name	City	State
United States	The University of Alabama	Tuscaloosa	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama, Tuscaloosa	McCormick Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of fecal short chain fatty acids including acetate, proprionate, and butyrate	Units - uM	pre/post each four-week study arm
Primary	Concentration of serum leptin	Units - ng/mL	pre/post each four-week study arm
Primary	Concentration of serum ghrelin (pg/mL)	Units - pg/mL	pre/post each four-week study arm
Primary	Concentration of serum peptide tyrosine tyrosine (PYY)	Units - pg/mL	pre/post each four-week study arm