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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03591588
Other study ID # H21418
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2016
Est. completion date March 31, 2020

Study information

Verified date July 2020
Source Baylor College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date March 31, 2020
Est. primary completion date March 31, 2020
Accepts healthy volunteers No
Gender All
Age group 21 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Center for Prevention of cardiometabolic disease Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effects of diet interventions on monocyte phenotypes Monocyte phenotypes 2016 to 2020
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