Status:
COMPLETED
Alleviation Of Metabolic Endotoxemia In Adults With Metabolic Syndrome With Milk Fat Globule Membrane
Lead Sponsor:
Ohio State University
Conditions:
Metabolic Syndrome
Metabolic Endotoxemia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 ...
Detailed Description
Background and hypothesis: Our preclinical evidence shows that phospholipid-rich milk fat globule membrane (MFGM) attenuates lipopolysaccharide-induced increases in gut permeability and pro-inflammat...
Eligibility Criteria
Inclusion
- Serum Glucose 100-126 mg/dl
- Waist C \>89/102 cm; F/M
- Serum HDL-C: \<50/40 mg/dl; F/M
- Serum triglyceride: \>150 mg/dl
- Blood Pressure \>130/85 mmHg
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03860584
Start Date
July 1 2019
End Date
December 20 2020
Last Update
November 18 2025
Active Locations (1)
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1
The Ohio State University
Columbus, Ohio, United States, 43201