Status:
RECRUITING
Probiotics and Gut Health
Lead Sponsor:
Penn State University
Collaborating Sponsors:
United States Department of Agriculture (USDA)
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
55-75 years
Phase:
PHASE1
PHASE2
Brief 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 probi...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03418857
Start Date
June 29 2018
End Date
December 1 2022
Last Update
December 14 2021
Active Locations (1)
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1
The Pennsylvania State University
University Park, Pennsylvania, United States, 16802