Effects of Diet Interventions on Monocytes in Metabolic Syndrome

Baylor College of Medicine

Status: Completed

Conditions: Hypertriglyceridemia; Metabolic Syndrome

Treatments: Other: diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03591588

H21418

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

high-saturated fat diet

Active Comparator group

Description:

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

Treatment:

Other: diet

low-fat diet

Active Comparator group

Description:

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

Treatment:

Other: diet