Effects of Diet Interventions on Monocytes in Metabolic Syndrome

NCT03591588 | Completed

• 1 other identifier: H21418
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome; Hypertriglyceridemia

Outcome Measures

Primary Outcomes (1)

• Effects of diet interventions on monocyte phenotypes

  Monocyte phenotypes

  2016 to 2020

Study Arms (2)

high-saturated fat diet

ACTIVE COMPARATOR

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

Other: diet

low-fat diet

ACTIVE COMPARATOR

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

Other: diet

Interventions

diet OTHER

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.

high-saturated fat diet; low-fat diet

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Obese women and men with metabolic syndrome (MS)
• Fasting triglyceride (TG) equal to or greater than 150 mg/dl

You may not qualify if:

• \<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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Center for Prevention of cardiometabolic disease

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Lian Z, Perrard XD, Antony AK, Peng X, Xu L, Ni J, Zhang B, O'Brien V, Saeed A, Jia X, Hussain A, Yu B, Simon SI, Sacks FM, Hoogeveen RC, Ballantyne CM, Wu H. Dietary Effects on Monocyte Phenotypes in Subjects With Hypertriglyceridemia and Metabolic Syndrome. JACC Basic Transl Sci. 2023 Apr 26;8(5):460-475. doi: 10.1016/j.jacbts.2023.02.011. eCollection 2023 May.

  PMID: 37325398 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Hypertriglyceridemia

Interventions

Diet

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• HUAIZHU WU, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: July 19, 2018
• Study Start: April 1, 2016
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: July 8, 2020

Record last verified: 2020-07

Locations

US (1)