NCT07313787

Brief 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....

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
64mo left

Started Apr 2026

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 2, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

April 21, 2026

Expected
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2030

1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2031

Last Updated

April 16, 2026

Status Verified

March 30, 2026

Enrollment Period

3.8 years

First QC Date

December 31, 2025

Last Update Submit

April 15, 2026

Conditions

Nephrotic SyndromeLipodystrophyMetabolic SyndromeDiabetesHealthy VolunteerMetabolic Associated Steatotic Liver Disease

Keywords

postprandial lipidsmacronutrientCARBOHYDRATESFATSProteins

Outcome Measures

Primary Outcomes (1)

  • Determine the difference in postprandial triglycerides between meals of different macronutrient composition within each study cohort.

    Difference in baseline adjusted AUC for TG for 8 hours after meals of different macronutrient composition.

    8 hours

Secondary Outcomes (1)

  • Determine differences in post-prandial triglycerides between different study populations.

    8 hours

Study Arms (4)

Healthy

EXPERIMENTAL

Healthy

Other: High carb then high fat breakfastOther: High fat then high carb breakfast

Lipodystrophy

EXPERIMENTAL

Lipodystrophy

Other: High carb then high fat breakfastOther: High fat then high carb breakfast

Metabolic syndrome

EXPERIMENTAL

Metabolic syndrome

Other: High carb then high fat breakfastOther: High fat then high carb breakfast

Nephrotic syndrome

EXPERIMENTAL

Nephrotic syndrome

Other: High carb then high fat breakfastOther: High fat then high carb breakfast

Interventions

High carb then high fat breakfastOTHER

High carb then high fat breakfast

HealthyLipodystrophyMetabolic syndromeNephrotic syndrome
High fat then high carb breakfastOTHER

High fat then high carb breakfast

HealthyLipodystrophyMetabolic syndromeNephrotic syndrome

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In order to be eligible to participate in this study, an individual must meet all of the following 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)
  • Not taking any medications or supplements that, in the opinion of the investigator, would interfere with interpretation of study data.
  • \. Obesity defined as either
  • BMI \>30 kg/m\^2 (or \>=27 kg/m\^2 in participants of Asian descent), OR
  • Elevated waist circumference as defined below:
  • Country/Ethnic group - Europid, Sub-Saharan African, Eastern Mediterranean and Middle East (Arab):
  • Sex: Male - Waist circumference: \>=94cm
  • +26 more criteria

You may not qualify if:

  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • 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).
  • 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.
  • 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.
  • History of hypertriglyceridemia-induced pancreatitis within 3 months prior to screening.
  • Positive pregnancy test or breastfeeding at screening.
  • Clinically significant abnormalities in thyroid function, blood counts, as assessed by screening labs.
  • Acute cardiovascular events within the past 6 months
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

MeSH Terms

Conditions

Nephrotic SyndromeLipodystrophyMetabolic SyndromeDiabetes Mellitus

Condition Hierarchy (Ancestors)

NephrosisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSkin Diseases, MetabolicSkin DiseasesSkin and Connective Tissue DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersEndocrine System Diseases

Study Officials

  • Rebecca J Brown, M.D.

    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca J Brown, M.D.

CONTACT

(301) 594-0609rebecca.brown@nih.gov

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2025

First Posted

January 2, 2026

Study Start (Estimated)

April 21, 2026

Primary Completion (Estimated)

February 1, 2030

Study Completion (Estimated)

August 1, 2031

Last Updated

April 16, 2026

Record last verified: 2026-03-30

Data Sharing

IPD Sharing
Will share

This study will collect data from subjects enrolled at the NIH Clinical Center to meet the primary and secondary endpoints as stated in the protocol. Demographic, laboratory results, clinical observations and imaging studies will be acquired from up to 100 participants.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Scientific data included in published manuscripts will be made available at the time of publication; all other generated scientific data will be shared no later than the termination date of the study. The study data will be stored in the repository for at least 5 years.
Access Criteria
Identifiable data will be de-identified prior to repository submission. Participant-level clinical data described above will be preserved through deposition of the data in a controlled access public repository. Scientific data included in published manuscripts will be made available at the time of publication; all other generated scientific data will be shared no later than the termination date of the study.

Locations

US(1)