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Probiotics and Gut Health
RecruitingPhase 1/2
The Role of Probiotics in Attenuating Inflammation and Improving Gut Health in Obese Adults
Who can join
Ages 55 to 75 · All sexes
Full 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)
About the study
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.
What is being tested
- Yogurt smoothie with BB-12 (drug)
- Yogurt smoothie (drug)
Sponsor: Penn State University · Participants: 40 · Started: Jun 29, 2018
Contact the study team
- Connie J Rogers, PhD, MPH · Phone: 814 867 3716
Official record on ClinicalTrials.gov — NCT03418857
Locations in the U.S.
| Pennsylvania | The Pennsylvania State University, University Park |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.