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Completed

NCT Number: NCT03901014

Investigating the Production of Lipoproteins and Acetyl-CoA During a Ketogenic Diet

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.

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Key information

Conditions

Cholesterol Metabolism Ketone Metabolism

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Touro University California

Vallejo, California, 94592, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Standard American Diet

Other

Standard American diet with 50% energy from carbohydrate, 30% from fat, and 20% from protein.

Very low carbohydrate diet

Other

Ketogenic diet with <50g carbohydrate, 60-75% energy from fat, and 20% from protein

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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

Secondary outcomes

  1. Change in fractional hepatic de novo lipogenesis

    Time frame: Day 3 to Day 17

    Measured by the detection of incorporated 1-13C sodium acetate into palmitate in triglyceride rich lipoproteins (TRL)

  2. Change in fractional cholesterol synthesis

    Time frame: Day 3 to Day 17

    Measured by the detection of incorporated 1-13C sodium acetate into cholesterol in plasma

  3. Change in ketone body synthesis

    Time frame: Day 3 to Day 17

    Measured by the detection of incorporated 1-13C sodium acetate into ketone bodies in plasma

  4. Change in TRL-triglyceride kinetics

    Time frame: Day 3 to Day 17

    Change in TRL- triglyceride assembly rates as measured using 2-13C glycerol and mathematical modeling

  5. Change in triglyceride lipolysis

    Time frame: Day 3 to Day 17

    Measured by the dilution of administered 2-13C glycerol in plasma

  6. Change in serum glucose concentration

    Time frame: Day 3 to Day 17

    Change in fasting and postprandial serum glucose levels

  7. Change in serum free fatty acid concentration

    Time frame: Day 3 to Day 17

    Change in fasting and postprandial serum free fatty acid levels

  8. Change in serum insulin concentration

    Time frame: Day 3 to Day 17

    Change in fasting and postprandial serum insulin levels

  9. Change in serum ketone body concentration

    Time frame: Day 3 to Day 17

    Change in fasting and postprandial ketone body levels

Sponsors and collaborators

Lead sponsor

Touro University, California

Other

Registry information

Acronym: PLAK

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 3, 2019
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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