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Effects of Diet Interventions on Monocytes in Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT03591588
Recruitment Status : Completed
First Posted : July 19, 2018
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Huaizhu Wu, Baylor College of Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Hypertriglyceridemia Other: diet Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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 (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Diet Interventions on Monocyte Phenotypes in Individuals With Metabolic Syndrome
Actual Study Start Date : April 1, 2016
Actual Primary Completion Date : March 31, 2020
Actual Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: high-saturated fat diet
Diet high in saturated fat (~50% calorie from fat, ~25% from saturated fat)
 Other: 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.
Active Comparator: low-fat diet
Diet with low fat (~25% calorie from fat)
 Other: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Effects of diet interventions on monocyte phenotypes [ Time Frame: 2016 to 2020 ]
    Monocyte phenotypes


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03591588


Locations
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United States, Texas
Center for Prevention of cardiometabolic disease
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: HUAIZHU WU, MD Baylor College of Medicine
More Information
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Responsible Party: Huaizhu Wu, Associate Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03591588    
Other Study ID Numbers: H21418
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metabolic Syndrome
Hypertriglyceridemia
Syndrome
Disease
Pathologic Processes
Insulin Resistance
 Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders