Effects of Diet Interventions on Monocytes in Metabolic Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Diet Interventions on Monocyte Phenotypes in Individuals With Metabolic Syndrome

Conditions
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Metabolic Syndrome, Hypertriglyceridemia

Intervention / Treatment
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* Other: diet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The study includes 2 types of diets, i.e., high-saturated fat diet and low-fat high-protein diet, in the same individuals with randomized crossover design.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: high-saturated fat diet<br>Diet high in saturated fat ( 50% calorie from fat,  25% from saturated fat) | Other: diet<br>* The study includes 2 types of diets, i.e., high-saturated fat diet and low-fat high-protein diet, which are provided to each participant in a randomized crossover design.<br>|
| Active Comparator: low-fat diet<br>Diet with low fat ( 25% calorie from fat) | Other: diet<br>* The study includes 2 types of diets, i.e., high-saturated fat diet and low-fat high-protein diet, which are provided to each participant in a randomized crossover design.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of diet interventions on monocyte phenotypes | Monocyte phenotypes | 2016 to 2020 |