Clinical trial NCT06313580: Spices for Cultivating a Healthy Gut Microbiome and Cardiometabolic Profile
Official title: Spices for Cultivating a Healthy Gut Microbiome and Cardiometabolic Profile: the SPICE Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiometabolic Syndrome
Lead sponsor: University of Alabama, Tuscaloosa
Sponsor class: OTHER
Collaborators: name: McCormick Science Institute
First posted: 2024-03-15
Enrollment: 30
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Concentration of fecal short chain fatty acids including acetate, proprionate, and butyrate
timeFrame: pre/post each four-week study arm
measure: Concentration of serum leptin
timeFrame: pre/post each four-week study arm
measure: Concentration of serum ghrelin (pg/mL)
timeFrame: pre/post each four-week study arm
measure: Concentration of serum peptide tyrosine tyrosine (PYY)
timeFrame: pre/post each four-week study arm
Secondary outcomes:
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: The University of Alabama
state: Alabama
Study officials:
References: