Cholesterol MetabolismPLAKNCT03901014
Investigating the Production of Lipoproteins and Acetyl-CoA During a Ketogenic Diet
A study testing Standard American diet and Very low carbohydrate diet in people with Cholesterol Metabolism and Ketone Metabolism, run by Touro University, California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cholesterol Metabolism, Ketone Metabolism
- What is being tested?
- Standard American diet and Very low carbohydrate diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2019to 18 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- 18-50 years old
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Touro University California
Vallejo, California, 94592
About this study
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.
Read the detailed description
Participants will consume a standard American diet for one week followed by a very-low carbohydrate ketogenic diet (VLCKD, <50 grams carbohydrate/day) for two weeks. Participants will undergo an oral stable isotope tracer study during each diet to measure de novo synthesis of fatty acid, cholesterol, ketone bodies, and for measurement of apolipoprotein B and triglyceride kinetics.
- Conditions
- Cholesterol Metabolism, Ketone Metabolism
- Being tested
- Standard American diet, Very low carbohydrate diet
- Keywords
- ketogenic diet, LDL cholesterol, carbohydrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard American dietOther
Standard American diet with 50% energy from carbohydrate, 30% from fat, and 20% from protein.
Very low carbohydrate dietOther
Ketogenic diet with <50g carbohydrate, 60-75% energy from fat, and 20% from protein
| Study group | Role | What they receive |
|---|---|---|
| Baseline diet | Active comparator | 1 week baseline diet Receives: Other: Standard American diet |
| Very low carbohydrate diet | Experimental | 2 week very low carbohydrate ketogenic diet Receives: Other: Very low carbohydrate diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total cholesterol
Change in serum total cholesterol between Day 3-7 (average value) to Day 17-21 (average value)
Measured: Day 3-7 to Day 17-21
Change in low density lipoprotein (LDL) cholesterol
Change in serum LDL cholesterol between Day 3-7 (average value) to Day 17-21 (average value)
Measured: Day 3-7 to Day 17-21
Change in high density lipoprotein (HDL) cholesterol
Change in serum HDL cholesterol between Day 3-7 (average value) to Day 17-21 (average value)
Measured: Day 3-7 to Day 17-21
Change in apolipoprotein B (apoB) kinetics
Change in apoB turnover rates in LDL and very low density lipoprotein plasma fractions as measured using 2H2 leucine incorporation into apoB and mathematical modeling
Measured: Day 3-7 to Day 17-21
Secondary outcomes (9)
Change in fractional hepatic de novo lipogenesis
Measured by the detection of incorporated 1-13C sodium acetate into palmitate in triglyceride rich lipoproteins (TRL)
Measured: Day 3 to Day 17
Change in fractional cholesterol synthesis
Measured by the detection of incorporated 1-13C sodium acetate into cholesterol in plasma
Measured: Day 3 to Day 17
Change in ketone body synthesis
Measured by the detection of incorporated 1-13C sodium acetate into ketone bodies in plasma
Measured: Day 3 to Day 17
Change in TRL-triglyceride kinetics
Change in TRL- triglyceride assembly rates as measured using 2-13C glycerol and mathematical modeling
Measured: Day 3 to Day 17
Change in triglyceride lipolysis
Measured by the dilution of administered 2-13C glycerol in plasma
Measured: Day 3 to Day 17
Change in serum glucose concentration
Change in fasting and postprandial serum glucose levels
Measured: Day 3 to Day 17
Change in serum free fatty acid concentration
Change in fasting and postprandial serum free fatty acid levels
Measured: Day 3 to Day 17
Change in serum insulin concentration
Change in fasting and postprandial serum insulin levels
Measured: Day 3 to Day 17
Change in serum ketone body concentration
Change in fasting and postprandial ketone body levels
Measured: Day 3 to Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start29 Mar 2019
- Primary completion18 Apr 2019
- Study completion18 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholesterol MetabolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Touro University, California
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grace M Jones, PhD, Principal investigator, Touro University, California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901014
- Sponsor's protocol ID
- M-0419
- Acronym
- PLAK
- Status last verified
- Nov 2022
- First submitted
- 29 Mar 2019
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Production of Lipoproteins and Acetyl-CoA During a Ketogenic Diet
- ClinicalTrials.gov ID
- NCT03901014
- Acronym / sponsor ID
- PLAK / M-0419
- Conditions
- Cholesterol Metabolism, Ketone Metabolism
- Keywords
- ketogenic diet, LDL cholesterol, carbohydrate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Touro University, CaliforniaUniversity, hospital or other
- Study start
- 29 Mar 2019 (actual)
- Primary completion
- 18 Apr 2019 (actual)
- Study completion
- 18 Apr 2019 (actual)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants will consume a standard American diet for one week followed by a very-low carbohydrate ketogenic diet (VLCKD, <50 grams carbohydrate/day) for two weeks. Participants will undergo an oral stable isotope tracer study during each diet to measure de novo synthesis of fatty acid, cholesterol, ketone bodies, and for measurement of apolipoprotein B and triglyceride kinetics.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline diet | Active comparator | Other: Standard American diet1 week baseline diet |
| Very low carbohydrate diet | Experimental | Other: Very low carbohydrate diet2 week very low carbohydrate ketogenic diet |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male
- 18-50 years old
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard American dietStandard American diet with 50% energy from carbohydrate, 30% from fat, and 20% from protein. | Other | Baseline diet |
| Very low carbohydrate dietKetogenic diet with <50g carbohydrate, 60-75% energy from fat, and 20% from protein | Other | Very low carbohydrate diet |
Primary outcome
Change in total cholesterol
Time frame: Day 3-7 to Day 17-21
Change in serum total cholesterol between Day 3-7 (average value) to Day 17-21 (average value)
Change in low density lipoprotein (LDL) cholesterol
Time frame: Day 3-7 to Day 17-21
Change in serum LDL cholesterol between Day 3-7 (average value) to Day 17-21 (average value)
Change in high density lipoprotein (HDL) cholesterol
Time frame: Day 3-7 to Day 17-21
Change in serum HDL cholesterol between Day 3-7 (average value) to Day 17-21 (average value)
Change in apolipoprotein B (apoB) kinetics
Time frame: Day 3-7 to Day 17-21
Change in apoB turnover rates in LDL and very low density lipoprotein plasma fractions as measured using 2H2 leucine incorporation into apoB and mathematical modeling
9 secondary outcomes
Change in fractional hepatic de novo lipogenesis
Time frame: Day 3 to Day 17
Change in fractional cholesterol synthesis
Time frame: Day 3 to Day 17
Change in ketone body synthesis
Time frame: Day 3 to Day 17
Change in TRL-triglyceride kinetics
Time frame: Day 3 to Day 17
Change in triglyceride lipolysis
Time frame: Day 3 to Day 17
Change in serum glucose concentration
Time frame: Day 3 to Day 17
Change in serum free fatty acid concentration
Time frame: Day 3 to Day 17
Change in serum insulin concentration
Time frame: Day 3 to Day 17
Change in serum ketone body concentration
Time frame: Day 3 to Day 17
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace M Jones, PhD principal investigator
Touro University, California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard American diet and Very low carbohydrate diet in people with Cholesterol Metabolism and Ketone Metabolism, run by Touro University, California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total cholesterol (time frame: Day 3-7 to Day 17-21). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.