Effects of probiotics on gut health in people with metabolic syndrome
The Role of Probiotics in Attenuating Inflammation and Improving Gut Health in Obese Adults
This study is testing if eating yogurt with probiotics can improve gut health and reduce inflammation in people with metabolic syndrome.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 55 Years to 75 Years |
| Sex | All |
| Sponsor | Penn State University Academic / other |
| Locations | 1 site (University Park, Pennsylvania) |
| Trial ID | NCT03418857 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with a BMI between 25 and 35 kg/m² and at least one criterion for metabolic syndrome.
Not a fit: Patients with severe metabolic conditions or those allergic to dairy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-pharmacologic approach to improving gut health and managing metabolic syndrome.
How similar studies have performed: Other studies have shown promising results with probiotics in improving gut health, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
University Park, Pennsylvania
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.