Effects of Meal Macronutrients on Postprandial Lipids

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....

Conditions

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

Interventions

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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  lead NIH

Principal Investigators

• Rebecca J Brown, M.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

120 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-27

Primary Completion

2030-02-01

Completion

2031-08-01

FDA Device

Yes

Countries

• United States

Study Locations