Effects of Diet Interventions on Monocytes in Metabolic Syndrome

July 7, 2020 updated by: Huaizhu Wu, Baylor College of Medicine

Effects of Diet Interventions on Monocyte Phenotypes in Individuals With 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Center for Prevention of cardiometabolic disease

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Investigators

  • Principal Investigator: HUAIZHU WU, MD, Baylor College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

March 31, 2020

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

July 9, 2018

First Submitted That Met QC Criteria

July 9, 2018

First Posted (Actual)

July 19, 2018

Study Record Updates

Last Update Posted (Actual)

July 8, 2020

Last Update Submitted That Met QC Criteria

July 7, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H21418

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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