Recruiting

Gut Microbiome

Sponsor:

University of Alabama, Tuscaloosa

Code:

NCT06313580

Conditions

Cardiometabolic Syndrome

Eligibility Criteria

Sex: Female

Age: 50 - 69

Healthy Volunteers: Accepted

Interventions

Yogurt with added Spices

Yogurt without added Spices

Study Details

Brief 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.

Conditions

Cardiometabolic Syndrome

Study ID

NCT06313580

Start date

Jan 1, 2023

Status verified date

Mar, 2024

Completion date

Jun, 2025

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 50 - 69

Healthy Volunteers: Accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention Arm - Yogurt with added Spices

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

sham comparator: Sham Arm - Yogurt without added Spices

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

Interventions

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.

Primary outcome measure

  • Concentration of fecal short chain fatty acids including acetate, proprionate, and butyrate [ Time Frame: pre/post each four-week study arm ]
  • Concentration of serum leptin [ Time Frame: pre/post each four-week study arm ]
  • Concentration of serum ghrelin (pg/mL) [ Time Frame: pre/post each four-week study arm ]
  • Concentration of serum peptide tyrosine tyrosine (PYY) [ Time Frame: pre/post each four-week study arm ]

Central Contacts and Locations

Central contacts

Kristi M Crowe-White, PhD, RD

205-348-6173kcrowe@ches.ua.edu

Locations

The University of Alabama

Recruiting

Tuscaloosa, Alabama, United States, 35487

Contacts

Kristi M. Crowe-White, PhD, RD

205-348-6173kcrowe@ches.ua.edu

More Information

Sponsor

University of Alabama, Tuscaloosa

Last update posted

Mar 20, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama, Tuscaloosa on 2024-03-20.