Effect of Dietary Cholesterol on Plasma Lipids

Dietary Modification Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03698929
• Other study ID #: PhysiciansCRM
• Status: Completed
• Phase: N/A
• Start date: September 17, 2018
• Est. completion date: November 20, 2018

Study information

• Verified date: March 2019
• Source: Physicians Committee for Responsible Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: November 20, 2018
• Est. primary completion date: November 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dietary Modification
• Metabolic Diseases
• Nutritional and Metabolic Disease

Intervention

Other:
• Dietary Effect of Cholesterol - Egg Phase
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
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.

Locations

Country	Name	City	State
United States	Physicians Committee for Responsible Medicine	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Physicians Committee for Responsible Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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