Spices for Cultivating a Healthy Gut Microbiome and Cardiometabolic Profile

University of Alabama, Tuscaloosa30 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Cardiometabolic Syndrome

Interventions

Eligibility

Sex: FEMALEMin age: 50 YearsMax age: 69 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Spices for Cultivating a Healthy Gut Microbiome and Cardiometabolic Profile

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts