NCT07313787

Effects of Meal Macronutrients on Postprandial Lipids

Prospective Cross-Over Study of the Effects of Meal Macronutrients on Postprandial Lipids

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

Background: Abnormal fats in the blood can lead to many problems, including heart disease. Researchers want to learn more about how eating meals with different levels of nutrients affects fats in the blood. Specifically, they want to study people with too much body fat, too little body fat, and a kidney problem called nephrotic syndrome. Objective: To learn more about how different types of foods affect fat levels in the blood. Eligibility: People aged 18 years or older with a health condition that affects how their body handles fats. Healthy volunteers are also needed. Design: Participants will have 2 overnight stays in the clinic within 6 months. At each visit, after staying overnight, they will eat a breakfast casserole. At 1 visit, breakfast will be a high-fat, low carbohydrate meal. At the other, it will be a high-carbohydrate, low-fat meal. Participants will have a tube inserted into a vein in their arm. They will have blood drawn via the tube 12 times in 8 hours: 2 times before they eat the breakfast and 10 times after. Participants will have other tests during their stays: * A resting metabolic test captures the air they exhale and measures how much energy they use at rest. * A dual energy X-ray absorptiometry (DXA) scan measures how much fat and muscle they have. * A Fibroscan is a special type of ultrasound of the liver. * A body surface scan uses lasers to measure the total area of the body. * A bioelectric impedance (BIS) exam measures how fast small electric currents move through their body. Participants may opt to have a third visit. At this visit, the breakfast will be high in protein....

Detailed description

Study Description: This is a single site, randomized cross-over study assessing the effects of different test meals of varying macronutrient composition on post-prandial lipid metabolism. Studies will be conducted in healthy individuals and in several patient populations including those with nephrotic syndrome (NS), lipodystrophy, and metabolic syndrome. The study hypothesis is that the number, composition and kinetics of lipid-containing particles will differ in the post-prandial state: 1. Within subjects, comparing meals of differing macronutrient composition (i.e. high fat versus high carbohydrate) 2. Between subjects with different disorders (i.e., lipodystrophy vs. NS vs. healthy) 3. Within subjects before and after treatment of their underlying disorders (i.e. nephrotic vs non-nephrotic states) Objectives: * Primary Objective: Determine the difference in postprandial triglycerides between meals of different macronutrient composition within each study cohort. * Secondary Objective: Determine differences in post-prandial triglycerides between different study populations. Endpoints: * Primary Endpoint: Difference in baseline adjusted AUC for TG for 8 hours after meals of different macronutrient composition. * Secondary Endpoints: Difference in baseline adjusted AUC for TG for each meal test between study cohorts

Conditions

• Nephrotic Syndrome
• Lipodystrophy
• Metabolic Syndrome
• Healthy Volunteer
• Diabetes
• Metabolic Associated Steatotic Liver Disease

Interventions

Type	Name	Description
OTHER	High carb then high fat breakfast	High carb then high fat breakfast
OTHER	High fat then high carb breakfast	High fat then high carb breakfast

Timeline

• Start date: 2026-04-22
• Primary completion: 2030-02-01
• Completion: 2031-08-01
• First posted: 2026-01-02
• Last updated: 2026-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study