Accordingly, the purpose of this study is to evaluate the efficacy of 1) supplementation with Synbiotic (Plexus® Triplex), 2) commercially-available Probiotic, or 3) placebo control over 30 days on the gut microbiome, cardiometabolic health, body weight and body composition in healthy individuals.
To be included participants must be healthy, weight stable (± 4.4 lb for > 6 months prior), and 18 to 60 years of age. Participants will be expected to be relatively healthy without uncontrolled chronic disease (e.g. cardiovascular, metabolic, or pulmonary) and 1 or fewer positive risk factors for cardiovascular disease (e.g. high blood pressure, high cholesterol, etc.) as described by the American College of Sports Medicine/American Heart Association Criteria and presented in the table 1 below. Per College policy, participants who are visitors are required to be fully vaccinated against COVID-19, including a booster, and participants who are faculty, staff or students are required to be fully vaccinated against COVID-19 and receive a booster by January 24, 2022 or within 30 days of becoming eligible, unless a medical or religious exemption has been granted. Participants will be screened for eligibility by health history form in person baseline measurements are made (Figure 1). To ensure greater inclusion, ecological validity and representation, women will be included in this study; however, we will not control for menstrual cycle phase, but will document for possible statistical consideration.
Given the focus of the study those who are currently, or have recently used (<3 months), oral antibiotics or have diagnosed irritable bowel syndrome or gut/bowel maladies (short bowel syndrome, etc.) will be excluded. Subjects who present with 2 or more CVD risk factors (table above) or have uncontrolled/overt cardiovascular, pulmonary, or metabolic disease (Diabetes Mellitus), or recent blood donation (<8 weeks) will be excluded. Those who have cancer or are being treated for cancer will also be excluded. Women who are currently pregnant, breastfeeding, attempting to conceive, or amenorrheic (not associated with menopause or use of contraceptive medications) will also be excluded from the study. Anyone who is being treated for hypothyroid with levothyroxine will be excluded as one of the supplement ingredients, chromium polynicotinate, may interfere with this medication . Anyone with severe illness or compromised or suppressed immune system (e.g. taking immune suppressants, chronic viral infection or treatment) will be excluded. Anyone recently diagnosed (<1yr) with an eating disorder or food allergies will also be excluded.
Parallel
Synbiotic, Probiotic, Placebo
Dietary supplementUse of dietary supplements to improve gut microbiome and cardiometabolic health
Gut microbial diversity
alpha- and beta-diversity
Gut microbial count
Gut microbial species identification and quantification
Short Chain fatty acids
Short Chain Fatty Acid concentration
Blood pressure
Brachial and estimated central blood pressure
Vascular Stiffness
Aortic vascular stiffness
Vascular reactivity
Using the near-infrared vascular occlusion test
Heart Rate Variability
Time and frequency domain HRV parameters
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