Fatty meals may trap vitamin e in the blood, study suggests

NCT ID NCT07715890

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Cancelled before anyone took part.

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First seen Jul 21, 2026 · Last updated Sep 09, 2026 · Updated 34 times

Summary

This study investigates how eating three high-fat meals in a row changes vitamin E levels in the blood. Researchers will compare people with normal blood fats to those with high blood fats (hyperlipidemia). The goal is to understand whether fats in the blood can trap vitamin E, potentially lowering its availability to the body. Participants will consume specially prepared shakes without vitamin E, and their blood will be tested over 23 hours.

What this could mean

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

Active substance
high-fat liquid shake (vitamin E-stripped)
What this could lead to
If successful, this study could clarify why people with high blood fats may have lower vitamin E levels, potentially guiding future nutritional advice.
What could go wrong
This is a small, early-stage study focused on understanding a biological process, not testing a treatment. Results may not apply to real-world eating patterns or lead to direct health changes.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 48 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

Mar 2029

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 65 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 Cohort 1 1. Males and females between the ages of 18 to 65 2. BMI 18.5 - 26.9 kg/m\^2 3. Subject understands the protocol and provides written, informed consent in addition to a willingness to comply with specified follow-up instructions and evaluations 4. Normotensive, not on medications for hypertension 5. Not on glucose-lowering or lipid-lowing medications 6. Screening labs with baseline HbA1c \<5.7%, baseline fasting triglyceride \< 150 mg/dL and LDL \<100 mg/dL 7. Liver fat \<2% Cohort 2 1. Males and females between the ages of 18 to 65 2. BMI \>26 kg/m\^2 and \<36 kg/m\^2 3. Subject understands the protocol and provides written, informed consent in addition to a willingness to comply with specified follow-up instructions and evaluations. 4. Screening labs with baseline HbA1c \<= 7.5%, agree to be off or stop oral glucose-lowering medications (metformin), baseline fasting triglyceride \< 500 mg/dL and LDL \<190 mg/dL, agree to be off or stop oral lipid-lowing medications for 4-10 weeks prior to the inpatient visit. 5. Liver fat \<2% EXCLUSION CRITERIA 1. For women: pregnancy or currently breastfeeding 2. Subjects \<18-year-old. This age group has a broad spectrum of hormonal profiles, due to development and puberty, which significantly increases the heterogenicity of the study subjects. 3. Subjects \>65-year-old. This age group has significantly increased risk of cardiovascular diseases. To minimize the risk from temporarily suspending lipid- and glucose-lowering medications and stress from serial blood draws, we exclude these individuals. 4. Heavy alcohol user (males with \>2 drinks per day or \>14 drinks per week; female with \>1 drinks per day or \>7 drinks per week) 5. Current smoker, or former smoker who quit smoking \<15 years ago 6. Subjects with weight changes greater than 20% baseline body weight over the past 3 months 7. Subjects with lactose intolerance unwilling to take lactase 8. Subjects with type 1 diabetes 9. Subjects with hemoglobin \<11 g/dL or hematocrit \<33% 10. Subjects with abnormal liver function test results 11. Subjects with liver fat \>= 2% on abdominal MRI 12. Subjects with a history of pancreatitis, diabetes ketoacidosis, hyperosmolar hyperglycemic state, advanced atherosclerosis, cardiovascular diseases, kidney diseases, or liver diseases 13. Subjects with fat malabsorption including: history of gastrointestinal surgery, pancreatic insufficiency, inflammatory bowel disease, celiac disease, moderate-to-severe irritable bowel syndrome, and pathologic mutations impacting lipoprotein metabolism 14. Subjects on glucocorticoids \>1 week (not including topical glucocorticoids) 15. Subjects with HIV 16. Subjects with uncontrolled psychiatric and/or behavioral disorders 17. Subjects taking diabetes medications other than metformin 18. Anticipated surgery during the study period 19. Subjects with severe medication-resistant claustrophobia 20. Subjects who are unwilling to stop medications, vitamins and/or dietary supplements that investigators have requested to be held 21. Subjects participating in any other clinical study without informing investigators 22. Any other reason or clinical condition that the investigators judge would interfere with study participation and/or be unsafe for a participant or staff member

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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

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  1. The places running it

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Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

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