search
Back to results

Effect of Dietary Cholesterol on Plasma Lipids

Primary Purpose

Dietary Modification, Nutritional and Metabolic Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary Effect of Cholesterol - Egg Phase
Dietary Effect of Cholesterol - Non-Egg Phase
Sponsored by
Physicians Committee for Responsible Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dietary Modification focused on measuring dietary cholesterol, cholesterol, nutrition, egg yolks, eggs

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Physicians Committee for Responsible Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dietary Effect of Cholesterol - Egg Phase

Dietary Effect of Cholesterol - No-Egg Phase

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 25, 2018
Last Updated
March 18, 2019
Sponsor
Physicians Committee for Responsible Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT03698929
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 17, 2018 (Actual)
Primary Completion Date
November 20, 2018 (Actual)
Study Completion Date
November 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Physicians Committee for Responsible Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dietary Modification, Nutritional and Metabolic Disease
Keywords
dietary cholesterol, cholesterol, nutrition, egg yolks, eggs

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, double-blind, crossover
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dietary Effect of Cholesterol - Egg Phase
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Dietary Effect of Cholesterol - No-Egg Phase
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dietary Effect of Cholesterol - Egg Phase
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Dietary Effect of Cholesterol - Non-Egg Phase
Intervention Description
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 Outcome Measure Information:
Title
Effect of Dietary Cholesterol on Plasma Lipids
Description
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.
Time Frame
9 weeks total

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Physicians Committee for Responsible Medicine
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Effect of Dietary Cholesterol on Plasma Lipids

We'll reach out to this number within 24 hrs