Effects of Diet Interventions on Monocytes in Metabolic Syndrome

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03591588

Enrollment

Registered

2018-07-19

Start date

2016-04-01

Completion date

2020-03-31

Last updated

2020-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertriglyceridemia, Metabolic Syndrome

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.

Interventions

OTHERdiet

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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Outcomes Assessor)

Intervention 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.

Eligibility

Sex/Gender

ALL

Age

21 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Effects of diet interventions on monocyte phenotypes	2016 to 2020	Monocyte phenotypes

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026