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Nephrotic SyndromeNutrition and dietDiagnostics and screeningHealthy volunteersHealthmaxxingMetabolicPhase 2

What this study is

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....

What's being tested

  • High carb then high fat breakfast

    Intervention · OTHER

    High carb then high fat breakfast

  • High fat then high carb breakfast

    Intervention · OTHER

    High fat then high carb breakfast

Study details

Official title
Prospective Cross-Over Study of the Effects of Meal Macronutrients on Postprandial Lipids
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions
Nephrotic Syndrome · Lipodystrophy · Metabolic Syndrome · Healthy Volunteer · Diabetes · Metabolic Associated Steatotic Liver Disease
Enrolling
100 people
Starts
2026-11-11
Est. completion
2031-08-01
Design
Open-label, randomized, crossover, Phase 2
Record
View on ClinicalTrials.gov ↗