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NCT03418857 · ClinicalTrials.gov registry record · Phase 1
Probiotics and Gut Health
A Phase 1 study of Metabolic Syndrome, sponsored by Penn State University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT03418857: Recruiting Phase 1 study of Metabolic Syndrome, sponsored by Penn State University.
NCT03418857 is a Phase 1 study of Metabolic Syndrome that is actively recruiting participants, run by Penn State University. The registered enrollment target is 40 participants, below the 1,205-participant average among 102 other Metabolic Syndrome trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03418857, a Phase 1 study of Metabolic Syndrome, is actively recruiting participants, sponsored by Penn State University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Change in inflammatory markers in the serum and secreted cytokines from lipopolysaccharide (LPS)-stimulated peripheral blood mononuclear cells compared to baseline. In the serum the markers to be investigated are high sensitivity c-reactive protein (hs-CRP), tumor necrosis factor alpha (TNF-a), interleukin 1 beta (IL-1B), IL-6, IL-8, IL-10, IL-12p70, monocyte chemotactic protein 1 (MCP-1), macrophage inflammatory protein alpha (MIP-1a), sCD14, and LPS binding protein (LPB). From LPS-stimulated p
Conditions Studied
Interventions
- DRUG Yogurt smoothie with BB-12
- DRUG Yogurt smoothie
Study Locations (1)
Pennsylvania
- The Pennsylvania State University - University Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-06-29 |
| Est. Completion | 2022-12 |
| Phase | Phase 1 |
What NCT03418857 shows while recruiting
NCT03418857 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,205-participant average among 102 other Metabolic Syndrome trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Metabolic Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Yogurt smoothie with BB-12 is the first listed.
NCT03418857 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03418857 about?
NCT03418857 is a clinical study titled "Probiotics and Gut Health". 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 is the current status of trial NCT03418857?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2018-06-29. Estimated completion is 2022-12.
What conditions does trial NCT03418857 study?
This clinical trial studies the following conditions: Metabolic Syndrome.
What interventions are being tested in trial NCT03418857?
The interventions under investigation include: Yogurt smoothie with BB-12 (DRUG), Yogurt smoothie (DRUG).
Who is sponsoring clinical trial NCT03418857?
This trial is sponsored by Penn State University, which has 219 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03418857 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metabolic Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03418857's enrollment target sits among peer trials
40 67th of 102 higher than 34 of 102 other Metabolic Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metabolic Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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