Effect of Dietary Cholesterol on Plasma Lipids



Status:Completed
Conditions:Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:3/22/2019
Start Date:September 17, 2018
End Date:November 20, 2018

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

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.

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.

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
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Washington, District of Columbia 20016
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