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Completed

NCT Number: NCT03591588

Effects of Diet Interventions on Monocytes in Metabolic Syndrome

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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Key information

Conditions

Metabolic Syndrome Dyslipidemias Glucose Metabolism Disorders Hyperinsulinism Hyperlipidemias Hypertriglyceridemia Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Prevention of cardiometabolic disease

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diet

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.

Primary outcomes

  1. Effects of diet interventions on monocyte phenotypes

    Time frame: 2016 to 2020

    Monocyte phenotypes

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jul 19, 2018
Registry last updated
Jul 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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