Probiotics and Gut Health (PRO)
Metabolic Syndrome
About this trial
This is an interventional treatment trial for Metabolic Syndrome focused on measuring probiotics, Human, obesity, non-pharmacologic therapy, gut health, microbiome, inflammation
Eligibility Criteria
Inclusion Criteria:
- BMI ≥ to 25 and less than 35 kg/m^2
- Increased waist circumference (men: ≥ 94 cm, women: ≥ 80 cm)
- At least one of the metabolic syndrome criteria-
- serum triglycerides: ≥ 150 mg/dL
- HDL cholesterol: ≤ 40 mg/dL in men, ≤ 50 mg/dL in women
- blood pressure: ≥ 130 mmHg systolic or ≥ 85 mmHg diastolic
- fasting plasma glucose ≥ 100 mg/dL
Exclusion Criteria:
- allergy to dairy
- smoking and/or use of tobacco products
- systolic blood pressure ≥ 160 mmHg
- diastolic blood pressure > 100 mmHg
- fasting glucose ≥ 126 mg/dL
- history of myocardial infarction, cardiovascular disease (CVD), stroke, diabetes mellitus, liver disease, kidney disease, thyroid disease (unless controlled on medication)
- use of cholesterol or lipid lowering medications
- use of anti-hypertensive or glucose lowering supplements (psyllium, fish oil capsules, soy lecithin, niacin, fiber, flax, phytoestrogens, and stanol/sterol supplemented foods)
- refusal to discontinue nutritional supplements, herbs, vitamins, or other probiotics
- clinical diagnosis of inflammatory bowel disease (IBD) e.g. Chron's disease or ulcerative colitis
- Use of antibiotics within the last 2 months
- excessive alcohol consumption (≥ 14 standard drinks per week)
- regular use of anti-inflammatory medications (e.g. aspirin, ibuprofen)
Sites / Locations
- The Pennsylvania State UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Experimental
Control
Participants will consume one yogurt smoothie daily for the duration of the intervention that contains 3.16 × 109 colony forming units (CFU) bifidobacterium animalis subsp. lactis BB-12. Participants will be asked to refrain from consumption of other yogurt or probiotic-containing foods.
Participants will consume one yogurt smoothie daily for the duration of the intervention that contains no BB-12. Participants will be asked to refrain from consumption of other yogurt or probiotic-containing foods.