Clinical trial NCT03698929: Effect of Dietary Cholesterol on Plasma Lipids
Official title: A Randomized, Double-blind, Crossover Study on the Effect of Dietary Cholesterol on Plasma Lipids in Individuals With No Baseline Cholesterol Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Modification
Nutritional and Metabolic Disease
Keywords: dietary cholesterol
cholesterol
nutrition
egg yolks
eggs
Lead sponsor: Physicians Committee for Responsible Medicine
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, double-blind, crossover
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Effect of Dietary Cholesterol on Plasma Lipids
timeFrame: 9 weeks total
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Physicians Committee for Responsible Medicine
state: District of Columbia
Study officials:
References: