Meal Macronutrients for Blood Fat Levels
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Rebecca J Brown, M.D.
Principal Investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Are You a Good Fit for This Trial?
This trial is for adults over 18 with conditions affecting body fat handling, like nephrotic syndrome or diabetes, and healthy individuals. Participants should have normal liver function tests, a BMI of at least 18.5 but less than 25 (or less than 23 for Asian descent), not drink excessively, and not be on interfering meds.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants will have 2 overnight stays in the clinic within 6 months, consuming meals with different macronutrient compositions and undergoing various tests.
Optional Extension
Participants may opt to have a third visit where the breakfast will be high in protein.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Meal Macronutrients
Trial Overview
The study examines how high-fat, high-carbohydrate, and optionally high-protein breakfasts affect blood fat levels in participants with varying health statuses related to body fat. It involves overnight clinic stays with multiple blood draws after eating the meals to measure changes in lipid profiles.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All subjects
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Lead Sponsor
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