Effect of Dietary Cholesterol on Plasma Lipids

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Dietary Modification, Nutritional and Metabolic Disease

Intervention / Treatment
-----------------
* Other: Dietary Effect of Cholesterol - Egg Phase
* Other: Dietary Effect of Cholesterol - Non-Egg Phase


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized, double-blind, crossover
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dietary Effect of Cholesterol - Egg Phase<br>In a randomized, 9-week crossover trial, we will test the effects of dietary cholesterol in individuals without baseline cholesterol intake through two 4-week dietary intervention periods, using baked goods containing egg yolks or egg-free baked goods. During the egg phase participants will consume two egg yolks a day for four weeks. Each week, participants will be given a week's worth of baked goods containing two egg yolks each. | Other: Dietary Effect of Cholesterol - Egg Phase<br>* 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.<br>|
| Placebo Comparator: Dietary Effect of Cholesterol - No-Egg Phase<br>In a randomized, 9-week crossover trial, we will test the effects of dietary cholesterol in individuals without baseline cholesterol intake through two 4-week dietary intervention periods, using baked goods containing egg yolks or egg-free baked goods. During the no-egg phase participants will consume an egg-free product for four weeks. Each week participants will be given a week's worth of egg-free baked goods. | Other: Dietary Effect of Cholesterol - Non-Egg Phase<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Dietary Cholesterol on Plasma Lipids | 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. | 9 weeks total | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dietary cholesterol, cholesterol, nutrition, egg yolks, eggs