RecruitingPhase 1 / Phase 2

Probiotics and Gut Health

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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)

Study sites (1)

PA