Investigating the Production of Lipoproteins and Acetyl-CoA During a Ketogenic Diet (NCT03901014) | Clinical Trial Compass
CompletedNot Applicable
Investigating the Production of Lipoproteins and Acetyl-CoA During a Ketogenic Diet
United States4 participantsStarted 2019-03-29
Plain-language summary
The purpose of this study is to understand how the reduction in dietary carbohydrates in a very-low carbohydrate ketogenic diet impacts the synthesis of cholesterol, fatty acid, and ketones, and the turnover rate of VLDL and chylomicron particles.
Who can participate
Age range
18 Years – 50 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male
* 18-50 years old
Exclusion Criteria:
* Use of nicotine products
* Has dietary restrictions
* Lactose intolerance
* History of GI disorders, diabetes, liver, kidney, or thyroid disorders
* Taking hypolipidemic, anti-diabetic, anti-hypertensive, or anti-depression medication
* Screening plasma triglyceride \< 50mg/dl or \>500mg/dl
* Screening glucose \> 125mg/dl
* Screening total and LDL-Cholesterol over 95th %tile for age and sex
* BP \> 160/95 mmHg
* Weight loss/gain \> 5% in the previous 3 months (self-reported)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in total cholesterol
Timeframe: Day 3-7 to Day 17-21
2
Change in low density lipoprotein (LDL) cholesterol
Timeframe: Day 3-7 to Day 17-21
3
Change in high density lipoprotein (HDL) cholesterol