Effects of Diet Interventions on Monocytes in Metabolic Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2020-03-31

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.

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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.

Conditions

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Metabolic Syndrome Hypertriglyceridemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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high-saturated fat diet

Diet high in saturated fat (\~50% calorie from fat, \~25% from saturated fat)

Group Type ACTIVE_COMPARATOR

diet

Intervention Type OTHER

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.

low-fat diet

Diet with low fat (\~25% calorie from fat)

Group Type ACTIVE_COMPARATOR

diet

Intervention Type OTHER

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.

Interventions

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diet

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.

Intervention Type OTHER

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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No