N/A
N=30
Alleviation Of Metabolic Endotoxemia In Adults With Metabolic Syndrome With Milk Fat Globule Membrane
Metabolic Syndrome · Metabolic Endotoxemia
Bottom Line
View on ClinicalTrials.gov: NCT03860584 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Serum Endotoxin — 32.5; 30.6 EU/ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MFGM-enriched full-fat dairy milk (Dietary_supplement); Soy phospholipid/lecithin milk (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ohio State University
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Endotoxin |
3855.4; 3972.6 | — |
| PRIMARY Serum Endotoxin |
3855.4; 3972.6 | — |
| SECONDARY Plasma Glucose |
98.1; 99.6 | — |
| SECONDARY Plasma Glucose |
98.1; 99.6 | — |
| SECONDARY Plasma Insulin |
16253.2; 13678.3 | — |
| SECONDARY Plasma Insulin |
16253.2; 13678.3 | — |
| SECONDARY Plasma HDL-C |
32.3; 34.1 | — |
| SECONDARY Plasma Triglyceride |
101.7; 103.3 | — |
| SECONDARY Plasma Total Cholesterol |
187.0; 161.8 | — |
| SECONDARY Plasma Glucagon-like Peptide-1 |
6.0; 6.7 | — |
| SECONDARY Urine Lactulose/Mannitol |
0.0854; 0.0777 | — |
| SECONDARY Urine Sucralose/Erythritol |
0.0174; 0.0172 | — |
| SECONDARY Fecal Acetate |
39.7; 42.1 | — |
| SECONDARY Fecal Butyrate |
16.51; 19.96 | — |
| SECONDARY Fecal Propionate |
21.38; 23.73 | — |
| SECONDARY Plasma Gastric Inhibitory Polypeptide |
67.0; 90.6 | — |
| SECONDARY Fecal Calprotectin |
47.8; 53.0 | — |
| SECONDARY Fecal Myeloperoxidase |
166.7; 163.6 | — |
| SECONDARY Whole-blood Messenger RNA Expression of Toll-like Receptor-4 at Fasting |
.087; .91 | — |
| SECONDARY Whole-blood Messenger RNA Expression of Interleukin-6 at Fasting |
0.81; 0.71 | — |
| SECONDARY Whole Blood Messenger RNA Expression of Tumor Necrosis Factor-alpha at Fasting |
0.91; 0.83 | — |
| SECONDARY Whole Blood Messenger RNA Expression of Toll-like Receptor-4 at 3 h Post-meal Challenge |
0.89; 0.93 | — |
| SECONDARY Whole Blood Messenger RNA Expression of Interleukin-6 at 3 h Post-meal Challenge |
0.91; 0.85 | — |
| SECONDARY Whole Blood Messenger RNA Expression of Tumor Necrosis Factor-alpha at 3 h Post-meal Challenge |
0.75; 0.97 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Serum Glucose 100-126 mg/dl
- Waist C >89/102 cm; F/M
- Serum HDL-C: 150 mg/dl
- Blood Pressure >130/85 mmHg
Exclusion Criteria
- Unstable body mass (±2 kg over prior 3-mo)
- Vegetarian
- Food allergies or lactose intolerance
- User of dietary supplements or probiotics (within past 1-mo)
- Pregnancy, lactation, changes in birth control (within 6-mo)
- Any gastrointestinal disorders
- Chronic diarrhea
- Smoker
- Excess alcohol (>2 drinks/d)
- Excess aerobic exercise (>5 h/wk)
- Recent antibiotic or anti-inflammatory agent use
- Blood Pressure >140/90 mmHg
Data sourced from ClinicalTrials.gov (NCT03860584). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.