Probiotics and Gut Health



Status:Recruiting
Conditions:Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:55 - 75
Updated:11/9/2018
Start Date:June 29, 2018
End Date:December 2019
Contact:Connie J Rogers, PhD, MPH
Email:cjr102@psu.edu
Phone:814 867 3716

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The Role of Probiotics in Attenuating Inflammation and Improving Gut Health in Obese Adults

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.


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)
We found this trial at
1
site
University Park, Pennsylvania 16801
Principal Investigator: Connie J Rogers, PhD, MPH
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mi
from
University Park, PA
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