Effects of probiotics on gut health in people with metabolic syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates how consuming yogurt with probiotics affects inflammatory outcomes and gut health in individuals with metabolic syndrome. Participants will alternate between consuming probiotic yogurt and regular yogurt in a randomized order, allowing for a comparison of effects. The study aims to gather data on various health metrics, including waist circumference, blood pressure, and lipid levels, to assess the impact of probiotics on metabolic health.

Why it matters

Who can join: the full rules

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)

Where it's running

• The Pennsylvania State University
  University Park, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Connie J Rogers, PhD, MPH
• Email: cjr102@psu.edu
• Phone: 814 867 3716

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.