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Breakfast showdown: High-Fat vs. High-Carb – which worsens blood fats?

NCT ID NCT07313787

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 58 times

Summary

This study looks at how eating a high-fat or high-carb breakfast changes fat levels in the blood over 8 hours. Researchers will compare results among people with conditions like diabetes, fatty liver, or kidney disease, as well as healthy volunteers. Participants will have two overnight clinic stays, blood draws, and body composition tests to understand these effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
High-carb or high-fat breakfast meals
What this could lead to
If successful, this could help tailor dietary advice for people with conditions like diabetes or kidney disease to better manage blood fat levels.
What could go wrong
This is a small, early-phase observational study, not a treatment trial. Results may not apply to everyone, and no direct health benefit is guaranteed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2031

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 120 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA: Common inclusion criteria (all groups): In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Age \>= 18 years 2. Average alcohol intake in the past 6 months \< 3 drinks (approximately 30g) per day (male) or \< 2 drinks (approximately 20 g) per day (female) Healthy control specific inclusion criteria: 1. In good general health with no known active medical conditions as evidenced by medical history 2. Fasting glucose \<100 mg/dL 3. HbA1c \<5.7% 4. Fasting triglycerides \<150 mg/dL 5. ALT and AST within normal limits 6. BMI \>=18.5 to \<25 kg/m\^2 (or \<23 kg/m\^2 in participants of Asian descent) 7. Not taking any medications or supplements that, in the opinion of the investigator, would interfere with interpretation of study data. Metabolic syndrome specific inclusion criteria 1. Obesity defined as either 1. BMI \>30 kg/m\^2 (or \>=27 kg/m\^2 in participants of Asian descent), OR 2. Elevated waist circumference as defined below: * Country/Ethnic group - Europid, Sub-Saharan African, Eastern Mediterranean and Middle East (Arab): * Sex: Male; Waist circumference: \>=94cm * Sex: Female; Waist circumference: \>=80cm * Country/Ethnic group - South Asian, Chinese, Japanese, Ethnic South and Central American: * Sex: Male; Waist circumference: \>=90cm * Sex: Female; Waist circumference: \>=80cm Plus any 2 of the following 2. Elevated triglycerides defined as EITHER 1. Fasting triglycerides \>= 150 mg/dL at screening, OR 2. Specific treatment for hypertriglyceridemia 3. Low HDL cholesterol, defined as EITHER 1. HDL \<40 mg/dL (males) or \<50 mg/dL (females) at screening, OR 2. Specific treatment for low HDL 4. Elevated blood pressure defined as EITHER 1. Systolic BP \>= 130 at screening, OR 2. Diastolic BP \>= 85 mm Hg at screening, OR 3. Treatment of previously diagnosed hypertension 5. Elevated glucose defined as EITHER 1. HbA1c \>= 5.7% (at screening), OR 2. Fasting serum glucose \>= 100 mg/dL (at screening), OR 3. 2-hour post-load glucose levels \>= 140 mg/dL (by history), OR 4. Prior diagnosis of type 2 diabetes Lipodystrophy-specific inclusion criteria: 1. Clinical diagnosis of generalized or partial lipodystrophy based on reduction in adipose tissue outside the normal range in some or all adipose depots (including, at a minimum, the gluteofemoral depot). 2. Insulin resistance as defined by fasting insulin \>22.5 or high exogenous insulin requirement (\> 2 units per kg per day or \> 200 units total per day) at screening. Nephrotic syndrome specific inclusion criteria 1. History of biopsy proven non-diabetic glomerular disease (any histology) 2. Nephrotic range proteinuria defined by ANY of the following: 1. Protein/creatinine ratio uPCR \>= 3.5 g/g at screening, OR 2. 24 hour protein excretion \>= 3.5 gr/24hr) at screening, OR 3. History of nephrotic range proteinuria (as defined above) within the past 5 years but in complete (defined as proteinuria \<= 0.3 g/day or partial remission (defined as a 50% or greater decrease in proteinuria compared to baseline and proteinuria \< 3.5 g/day) based on 24 hr urine or uPCR at time of screening EXCLUSION CRITERIA: Common exclusion criteria (all groups): An individual who meets any of the following criteria will be excluded from participation in this study: 1. Consuming extreme macronutrient diet (e.g., very low-carbohydrate, high fat diets such as ketogenic, "paleo" or Atkins diets, among others). 2. 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). 3. 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. 4. Body weight \>450 lbs (upper limit that can be accommodated by DXA scanner). 5. 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. 6. Uncontrolled diabetes, defined as HbA1c \>9% at screening. 7. Lipemia defined as fasting or non-fasting triglycerides of \>1000 mg/dL at screening. 8. Renal dysfunction defined as eGFR \<50 mL/min/1.73 m\^2 at screening. 9. In participants with liver disease, history of decompensated advanced liver disease, defined as direct bilirubin \> 0.5 g/dL, PT \> 18 seconds, albumin \< 3 g/dL, MELD score \> 12, or history of ascites, encephalopathy, variceal bleeding, spontaneous bacterial peritonitis or liver transplant. 10. History of hypertriglyceridemia-induced pancreatitis within 3 months prior to screening. 11. Positive pregnancy test or breastfeeding at screening. 12. Clinically significant abnormalities in thyroid function, blood counts, as assessed by screening labs. 13. Acute cardiovascular events within the past 6 months 14. Anemia (Hgb \<10 mg/dL in women or \<12 mg/dL in men) at screening 15. Food allergies or other dietary restrictions that could increase risk associated with test meals or cause the subject to be unwilling to consume test meals (i.e. celiac disease, vegan diets). 16. Subjects with chronic diarrhea, gastric bypass or lap-band procedures, ostomies, bowel motility problems, or other known conditions that could affect intestinal fat absorption. 17. Subjects treated with tamoxifen, estrogens, or progestins that have not been stable for \>4 weeks prior to screening. 18. Blood donation in the last 2 weeks or planned blood donation during the study 19. Subjects requiring regular transfusions for any reason. 20. Subjects with known gastroparesis 21. Inability to adhere to Lifestyle Considerations throughout study duration. 22. Inability of the subject to understand and the unwillingness to sign a written informed consent document. 23. Unwillingness to comply with all study procedures and unavailable for the duration of the study 24. Any other condition or medication which, in the opinion of the investigator, increases risk to the subject, prevents the subject from complying with study procedures, prevents the subject from completing the study, or interferes with the interpretation of study results.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.