Spices for Cultivating a Healthy Gut Microbiome and Cardiometabolic Profile

NCT06313580 | Recruiting

• 1 other identifier: 22-1055
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Concentration of fecal short chain fatty acids including acetate, proprionate, and butyrate

  Units - uM

  pre/post each four-week study arm

• Concentration of serum leptin

  Units - ng/mL

  pre/post each four-week study arm

• Concentration of serum ghrelin (pg/mL)

  Units - pg/mL

  pre/post each four-week study arm

• Concentration of serum peptide tyrosine tyrosine (PYY)

  Units - pg/mL

  pre/post each four-week study arm

Study Arms (2)

Intervention Arm - Yogurt with added Spices

EXPERIMENTAL

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

Other: Yogurt with added Spices

Sham Arm - Yogurt without added Spices

SHAM COMPARATOR

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

Other: Yogurt without added Spices

Interventions

Yogurt with added Spices OTHER

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

Intervention Arm - Yogurt with added Spices

Yogurt without added Spices OTHER

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

Sham Arm - Yogurt without added Spices

Eligibility Criteria

• Age: 50 Years - 69 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• post-menopausal women ages 50-69y with a BMI of 18.5 - 34.9 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama, Tuscaloosa: lead
• McCormick Science Institute: collaborator

Study Sites (1)

The University of Alabama

Tuscaloosa, Alabama, 35487, United States

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Yogurt

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cultured Milk Products; Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Foods; Dairy Products; Food; Food and Beverages

Central Study Contacts

Kristi M Crowe-White, PhD, RD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The study coordinator and participants are unblinded due to the nature of the study design and intervention; however, the PI will remain blinded.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In a single blind crossover design, participants are randomized to 4 weeks of yogurt intake twice daily with or without added spices with a two-week washout period between study arms.

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: March 15, 2024
• Study Start: January 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)