NCT03418857RecruitingPhase 1/2
Probiotics and Gut Health
The Role of Probiotics in Attenuating Inflammation and Improving Gut Health in Obese Adults
Source: ClinicalTrials.gov · Last updated 14 Dec 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 13 Dec 2017
- Start date
- 29 Jun 2018
- Primary completion date
- 31 Oct 2022
- Lead sponsor
- Penn State University
- Diseases
- Obesity
- NCT number
- NCT03418857
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 40
- From 29 Jun 2018 to the primary completion date, 31 Oct 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- use of cholesterol or lipid lowering medications
- regular use of anti-inflammatory medications (e.g. aspirin, ibuprofen)
Other illness
- allergy to dairy
- history of myocardial infarction, cardiovascular disease (CVD), stroke, diabetes mellitus, liver disease, kidney disease, thyroid disease (unless controlled on medication)
- clinical diagnosis of inflammatory bowel disease (IBD) e.g. Chron's disease or ulcerative colitis
Lab values
- fasting glucose ≥ 126 mg/dL
- use of anti-hypertensive or glucose lowering supplements (psyllium, fish oil capsules, soy lecithin, niacin, fiber, flax, phytoestrogens, and stanol/sterol supplemented foods)
Other
- smoking and/or use of tobacco products
- systolic blood pressure ≥ 160 mmHg
- diastolic blood pressure \> 100 mmHg
- refusal to discontinue nutritional supplements, herbs, vitamins, or other probiotics
- Use of antibiotics within the last 2 months
- excessive alcohol consumption (≥ 14 standard drinks per week)
Who the study is looking for
- 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
Age in the registry: 55 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Pennsylvania State University Coordinator of this site? Confirm its status | University Park | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.