Cardiometabolic Syndrome
Conditions
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).
Interventions
OTHERYogurt with added Spices
Consumption of twice daily yogurt with added spices for four weeks.
OTHERYogurt without added Spices
Consumption of twice daily yogurt without added spices for four weeks.
Sponsors
McCormick Science Institute
University of Alabama, Tuscaloosa
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Masking description
The study coordinator and participants are unblinded due to the nature of the study design and intervention; however, the PI will remain blinded.
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.
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 69 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of fecal short chain fatty acids including acetate, proprionate, and butyrate | pre/post each four-week study arm | Units - uM |
| Concentration of serum leptin | pre/post each four-week study arm | Units - ng/mL |
| Concentration of serum ghrelin (pg/mL) | pre/post each four-week study arm | Units - pg/mL |
| Concentration of serum peptide tyrosine tyrosine (PYY) | pre/post each four-week study arm | Units - pg/mL |
Countries
United States
Contacts
Primary ContactKristi M Crowe-White, PhD, RD
Outcome results
None listed