What this study is
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's being tested
- Yogurt smoothie with BB-12
Intervention · DRUG
During the one month intervention period, the participants will consume one yogurt smoothie with BB-12 daily.
- Yogurt smoothie
Intervention · DRUG
During the one month control period, the participants will consume one yogurt smoothie daily.
Study details
- Official title
- The Role of Probiotics in Attenuating Inflammation and Improving Gut Health in Obese Adults
- Sponsor
- Penn State University
- Conditions
- Metabolic Syndrome
- Enrolling
- 40 people
- Starts
- 2018-06-29
- Est. completion
- 2022-12
- Design
- Double-blind, randomized, crossover, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 55 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openThe Pennsylvania State University
University Park, Pennsylvania, United States
- Connie J Rogers · Contactcjr102@psu.edu
- Connie J Rogers, PhD, MPH · Principal investigator
Recruiting
Study team
Sponsor
Penn State University
Study ID STUDY0006843
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.