Effects of Meal Macronutrients on Postprandial Lipids

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ID
NCT07313787
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • High carb then high fat breakfast — OTHER
    High carb then high fat breakfast
  • High fat then high carb breakfast — OTHER
    High fat then high carb breakfast

Study Details

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....

Key Dates

Start date
Jun 16, 2026
Status verified
May 2026
Primary completion
Feb 1, 2030
Completion
Aug 1, 2031

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Healthy
    Healthy
  • Experimental: Lipodystrophy
    Lipodystrophy
  • Experimental: Metabolic syndrome
    Metabolic syndrome
  • Experimental: Nephrotic syndrome
    Nephrotic syndrome

Primary Outcome Measure

Determine the difference in postprandial triglycerides between meals of different macronutrient composition within each study cohort. [ Time Frame: 8 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
NIH Clinical Center Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

Find similar trials in Bethesda, MD

By research site
National Institutes of Health Clinical Center· Bethesda, MD

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