Skip to main content
OpenTrials
Completed

NCT Number: NCT03698929

Effect of Dietary Cholesterol on Plasma Lipids

The Physicians Committee is carrying out a research study to improve the investigator's understanding and expand the literature to quantify the effect of foods on blood cholesterol. This study will measure changes in low density lipoprotein (LDL) concentration, sometimes called "bad cholesterol," over 2 study periods of 4 weeks each, with 1 rest week in between. Approximately 50 subjects will participate in this study.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physicians Committee for Responsible Medicine

Washington D.C., District of Columbia, 20016, United States

About this study

In a 9-week double-blind, crossover trial, participants will consume baked goods with either 2 egg yolks or an isocaloric egg-free product daily for 4 weeks. After a one-week washout period, participants will cross to the other dietary intervention. Participants will be asked not to make changes to their exercise patterns or diet, apart from consuming the provided products, for the study period. Changes in LDL cholesterol concentrations will be the primary dependent variable.

Study evaluations, known as health assessments, will be held at the Physicians Committee's office.

Group assignment: After the study entry, will be assigned by chance, like the flip of a coin, to one of two groups. The participant will have an equal chance of being assigned to either group. Each group will be asked to consume baked goods daily. The two groups will consume the same baked goods, but in a different order. The baked goods will be made from wheat flour with a small amount of sugar, salt, yeast, and other ingredients that are common to baked goods. There will be no animal-derived ingredients, except that some products will contain egg. Each week, the participant will be given a week's worth of baked goods.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Following vegan diet for 6 or more months

Exclusion criteria

  • Following vegan for less than 6 months
  • Smoking during the past six months
  • Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
  • Pregnancy or intention to become pregnant during the study period
  • Unstable medical or psychiatric illness
  • Lack of English fluency
  • Inability or unwillingness to participate in all components of the study
  • Egg allergy
  • Use of cholesterol-lowering medications

Treatment and study plan

Dietary Effect of Cholesterol - Egg Phase

Other

After the study entry, you will be assigned by chance, like the flip of a coin, to one of two groups. You will have an equal chance of being assigned to either group. Each group will be asked to consume baked goods daily. The two groups will consume the same baked goods, but in a different order. Each week, you will be given a week's worth of baked goods.

Dietary Effect of Cholesterol - Non-Egg Phase

Other

After the study entry, you will be assigned by chance, like the flip of a coin, to one of two groups. You will have an equal chance of being assigned to either group. Each group will be asked to consume baked goods daily. The two groups will consume the same baked goods, but in a different order. Each week, you will be given a week's worth of baked goods.

Primary outcomes

  1. Effect of Dietary Cholesterol on Plasma Lipids

    Time frame: 9 weeks total

    Examining the change of plasma lipids after consuming dietary cholesterol daily for one of two 4 week intervention periods with a 1 week washout period.

Sponsors and collaborators

Lead sponsor

Physicians Committee for Responsible Medicine

Other

Registry information

Official study title

A Randomized, Double-blind, Crossover Study on the Effect of Dietary Cholesterol on Plasma Lipids in Individuals With No Baseline Cholesterol Intake

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 9, 2018
Registry last updated
Mar 20, 2019

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.

Published trials that share one or more normalized conditions with this study.