Effects of Diet Interventions on Monocytes in Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03591588
• Other study ID #: H21418
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Hypertriglyceridemia
• Metabolic Syndrome
• Syndrome

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