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Effects of Diet Interventions on Monocytes in Metabolic Syndrome

Primary Purpose

Metabolic Syndrome, Hypertriglyceridemia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

diet

About this trial

This is an interventional basic science trial for Metabolic Syndrome

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Center for Prevention of cardiometabolic disease

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

high-saturated fat diet

low-fat diet

Arm Description

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

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

Outcomes

Primary Outcome Measures

Effects of diet interventions on monocyte phenotypes

Monocyte phenotypes

Secondary Outcome Measures

Full Information

NCT ID

NCT03591588

First Posted

July 9, 2018

Last Updated

July 7, 2020

Sponsor

Baylor College of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT03591588

Brief Title

Effects of Diet Interventions on Monocytes in Metabolic Syndrome

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

April 1, 2016 (Actual)

Primary Completion Date

March 31, 2020 (Actual)

Study Completion Date

March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Baylor College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome, Hypertriglyceridemia

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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

Outcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

high-saturated fat diet

Arm Type

Active Comparator

Arm Description

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

Arm Title

low-fat diet

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

diet

Intervention Description

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 Outcome Measure Information:

Title

Effects of diet interventions on monocyte phenotypes

Description

Monocyte phenotypes

Time Frame

2016 to 2020

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

HUAIZHU WU, MD

Organizational Affiliation

Baylor College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Center for Prevention of cardiometabolic disease

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Effects of Diet Interventions on Monocytes in Metabolic Syndrome

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