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Effects of Diet Interventions on Monocytes in Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT03591588
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Huaizhu Wu, 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, high-monounsaturated fat "Mediterranean type" 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The study includes 2 phases, each of which includes 2 arms: phase 1 includes high-saturated fat diet and low-fat diet; phase 2 includes high-saturated fat diet and high monounsaturated fat Mediterranean type diet.
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
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


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 phases, each of which includes 2 arms: phase 1 includes high-saturated fat diet and low-fat diet; phase 2 includes high-saturated fat diet and high monounsaturated fat Mediterranean type diet. The diets 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 phases, each of which includes 2 arms: phase 1 includes high-saturated fat diet and low-fat diet; phase 2 includes high-saturated fat diet and high monounsaturated fat Mediterranean type diet. The diets are provided to each participant in a randomized crossover design.

Active Comparator: Mediterranean diet
Diet high in monounsaturated fat (~50% calorie from fat, ~25% from monounsaturated diet).
Other: diet
The study includes 2 phases, each of which includes 2 arms: phase 1 includes high-saturated fat diet and low-fat diet; phase 2 includes high-saturated fat diet and high monounsaturated fat Mediterranean type diet. The diets are provided to each participant in a randomized crossover design.




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



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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.

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


Contacts
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Contact: HUAIZHU WU, MD 7137984141 hwu@bcm.edu
Contact: Christie M Balllantyne, MD 7137985034 cmb@bcm.edu

Locations
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United States, Texas
Center for Prevention of cardiometabolic disease Recruiting
Houston, Texas, United States, 77030
Contact: Sharon Goss    713-798-8800    sgoss@bcm.edu   
Sponsors and Collaborators
Baylor College of Medicine

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Responsible Party: Huaizhu Wu, Associate Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03591588     History of Changes
Other Study ID Numbers: H21418
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019

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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
Syndrome
Hypertriglyceridemia
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders