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N/A N=30 Randomized Double-blind Prevention

Alleviation Of Metabolic Endotoxemia In Adults With Metabolic Syndrome With Milk Fat Globule Membrane

Metabolic Syndrome · Metabolic Endotoxemia

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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