Probiotics and Gut Health

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Penn State University
• Collaborator: United States Department of Agriculture (USDA)

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)