NCT03418857 Probiotics and Gut Health
| NCT ID | NCT03418857 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Penn State University |
| Condition | Metabolic Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2018-06-29 |
| Primary Completion | 2022-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2018-06-29 with a primary completion date of 2022-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03418857 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 75 Years, studying Metabolic Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03418857 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03418857 currently recruiting?
Yes, NCT03418857 is actively recruiting participants. Contact the research team at cjr102@psu.edu for enrollment information.
Where is the NCT03418857 trial being conducted?
This trial is being conducted at University Park, United States.
Who is sponsoring the NCT03418857 clinical trial?
NCT03418857 is sponsored by Penn State University. The trial plans to enroll 40 participants.