Effects of Diet Interventions on Monocytes in Metabolic Syndrome

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Hypertriglyceridemia
• Interventions: Other: diet

• Registration Number: NCT03591588
• Lead Sponsor: Baylor College of Medicine

Brief Summary

Subjects with hypertriglyceridemia and metabolic syndrome are being recruited and receive diet interventions with either a high-saturated fat diet or a low-fat high protein diet for 4 days (days 1-4) and a breakfast on day 5. Blood samples are collected on day 1 and day 5 to examine lipid levels and circulating monocyte phenotypes.

Detailed Description

Subjects with hypertriglyceridemia and metabolic syndrome are being recruited and receive diet interventions with either a high-saturated fat diet or a low-fat high protein diet for 4 days (days 1-4) and a breakfast on day 5. Blood samples are collected on day 1 at fasting state and on day 5 at fasting state and 4 and 6 hours after the breakfast to examine lipid levels and circulating monocyte phenotypes.

Study Timeline

• Study Start: 2016-04-01
• Study First Submitted: 2018-07-09
• Study First Submitted QC: 2018-07-09
• Study First Posted: 2018-07-19
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-07
• Last Update Posted: 2020-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Obese women and men with metabolic syndrome (MS)
• Fasting triglyceride (TG) equal to or greater than 150 mg/dl

Exclusion Criteria

• <21 years of age
• Perimenopausal, pregnant or breastfeeding women
• Current smokers
• Obvious inflammation or other acute illnesses
• Obesity due to endocrinologic disorders including polycystic ovary syndrome
• Partial lipodystrophy
• Diabetes requiring insulin or >1 oral medication
• Fasting TG ≥650 mg/dl
• A history of pancreatitis
• Myocardial infarction within the past 3 years
• Any hospitalization within the past 2 months
• Takes steroids.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
low-fat diet	diet	Diet with low fat (\~25% calorie from fat)
high-saturated fat diet	diet	Diet high in saturated fat (\~50% calorie from fat, \~25% from saturated fat)

Primary Outcome Measures

Name	Time	Method
Effects of diet interventions on monocyte phenotypes	2016 to 2020	Monocyte phenotypes

Trial Locations

Locations (1)

Center for Prevention of cardiometabolic disease; 🇺🇸 Houston, Texas, United States