Effects of Meal Macronutrients on Postprandial Lipids (NCT07313787) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
United States100 participantsStarted 2026-05-13
Plain-language 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....
Who can participate
Age range18 Years – 120 Years
SexALL
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Inclusion criteria
✓. Age \>= 18 years
✓. Average alcohol intake in the past 6 months \< 3 drinks (approximately 30g) per day (male) or \< 2 drinks (approximately 20 g) per day (female)
✓. In good general health with no known active medical conditions as evidenced by medical history
✓. Fasting glucose \<100 mg/dL
✓. HbA1c \<5.7%
✓. Fasting triglycerides \<150 mg/dL
✓. ALT and AST within normal limits
✓. BMI \>=18.5 to \<25 kg/m\^2 (or \<23 kg/m\^2 in participants of Asian descent)
Exclusion criteria
✕. Consuming extreme macronutrient diet (e.g., very low-carbohydrate, high fat diets such as ketogenic, paleo or Atkins diets, among others).
✕. Plans to actively gain or lose weight during the study period (other than changes in water balance as clinically needed in subjects with nephrotic syndrome).
What they're measuring
1
Determine the difference in postprandial triglycerides between meals of different macronutrient composition within each study cohort.
Timeframe: 8 hours
Trial details
NCT IDNCT07313787
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
✕. Change in body weight of \>5% or \>3 kg (whichever is larger) in the 3 months prior to screening (by participant report) in participants who do NOT have nephrotic syndrome.
✕. Body weight \>450 lbs (upper limit that can be accommodated by DXA scanner).
✕. Participating in a regular strenuous exercise program (\> 2h/week of vigorous activity) as determined by volunteer report or evidence of vigorous exercising in order to lose weight, change body shape, or to counteract the effects of eating.
✕. Uncontrolled diabetes, defined as HbA1c \>9% at screening.
✕. Lipemia defined as fasting or non-fasting triglycerides of \>1000 mg/dL at screening.
✕. Renal dysfunction defined as eGFR \<50 mL/min/1.73 m\^2 at screening.