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NCT03860584 · ClinicalTrials.gov registry record · NA
Alleviation Of Metabolic Endotoxemia In Adults With Metabolic Syndrome With Milk Fat Globule Membrane
A NA study, sponsored by Ohio State University.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT03860584 is a NA study that has completed, run by Ohio State University. The registered enrollment target is 30 participants.
The verdict
NCT03860584, a NA study, has completed, sponsored by Ohio State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
Metabolic syndrome (MetS) adults (n = 24; 18-65 y) will be enrolled to complete a 2-arm, double-blind, randomized controlled, crossover trial. They will be randomized in 4-unit blocks to receive, for 13 d, a controlled diet with dairy milk (3.5% fat; 3 servings/d) enriched with milk fat globule membrane (MFGM, MEB) or a matched dairy milk that instead contains soy lecithin/phospholipid (control, COMP). All foods during each study period will be provided to ensure weight maintenance and to increase homogeneity of gut and host responses. Anthropometrics and blood pressure will be assessed at days 0, 7, and 13. Prior to (day 0) and after each 2-wk arm (day 13), a fasting blood sample will be collected to assess serum endotoxin and metabolic chemistries (glucose, lipids, insulin), and Toll-like receptor 4 /nuclear factor kappaB (TLR4/NFκB)-dependent genes from whole blood. A breath sample will be collected to assess the correlation analysis of plasma metabolic biomarkers. After the 2-week intervention, from fecal samples collected on day 13, the investigators will assess microbiota composition and function, short chain fatty acids (SCFA), and intestinal inflammatory markers (calprotectin, myeloperoxidase). On d 13, participants in the fasted state will receive a high-fat/high-glucose meal challenge to induce gut-derived endotoxin translocation. At 30-minute intervals for 3-hour, the investigators will evaluate circulating endotoxin, glucose, and insulin; TLR4/NFκB-dependent genes will be assessed from whole blood at 0 hour and 3-hour. Gut permeability probes will be co-administered with the test meal challenge, and 24-hour urine will be collected to assess gut barrier integrity. Participants will then undergo a 2-week washout prior to receiving the alternative treatment and completing all procedures in an identical manner.
Interventions
- DIETARY_SUPPLEMENT MFGM-enriched full-fat dairy milk
- DIETARY_SUPPLEMENT Soy phospholipid/lecithin milk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-07-01 |
| Est. Completion | 2020-12-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03860584
The ClinicalTrials.gov registry entry for NCT03860584 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which MFGM-enriched full-fat dairy milk is the first listed.
NCT03860584 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03860584 about?
NCT03860584 is a clinical study titled "Alleviation Of Metabolic Endotoxemia In Adults With Metabolic Syndrome With Milk Fat Globule Membrane". Metabolic syndrome (MetS) adults (n = 24; 18-65 y) will be enrolled to complete a 2-arm, double-blind, randomized controlled, crossover trial. They will be randomized in 4-unit blocks to receive, for 13 d, a controlled diet with dairy milk (3.5% fat; 3 servings/d) enriched with milk fat globule memb...
What is the current status of trial NCT03860584?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2019-07-01. Estimated completion is 2020-12-20.
What interventions are being tested in trial NCT03860584?
The interventions under investigation include: MFGM-enriched full-fat dairy milk (DIETARY_SUPPLEMENT), Soy phospholipid/lecithin milk (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03860584?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
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