Probiotics and Gut Health
Purpose
This study evaluates the effects of probiotic consumption on inflammatory outcomes and measures of gut health. Participants will be given yogurt with probiotics for one period and yogurt without probiotics for another, with a break in between. These periods will occur in random order.
Condition
- Metabolic Syndrome
Eligibility
- Eligible Ages
- Between 55 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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)
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Experimental |
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. |
|
|
Placebo Comparator Control |
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. |
|
Recruiting Locations
The Pennsylvania State University
University Park, Pennsylvania 16802
University Park, Pennsylvania 16802
More Details
- NCT ID
- NCT03418857
- Status
- Recruiting
- Sponsor
- Penn State University