Effect of Dietary Cholesterol on Plasma Lipids

NCT03698929 | Completed

• 1 other identifier: PhysiciansCRM
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Dietary Modification; Nutritional and Metabolic Disease

Keywords

dietary cholesterol; cholesterol; nutrition; egg yolks; eggs

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Dietary Effect of Cholesterol - Egg Phase

ACTIVE COMPARATOR

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

Dietary Effect of Cholesterol - No-Egg Phase

PLACEBO COMPARATOR

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

Interventions

Dietary Effect of Cholesterol - Egg Phase OTHER

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 - Egg Phase

Dietary Effect of Cholesterol - Non-Egg Phase OTHER

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 - No-Egg Phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Following vegan diet for 6 or more months

You may not qualify if:

• 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

Sponsors & Collaborators

• Physicians Committee for Responsible Medicine: lead

Study Sites (1)

Physicians Committee for Responsible Medicine

Washington D.C., District of Columbia, 20016, United States

Location

MeSH Terms

Conditions

Metabolic Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, crossover

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: October 9, 2018
• Study Start: September 17, 2018
• Primary Completion: November 20, 2018
• Study Completion: November 20, 2018
• Last Updated: March 20, 2019

Record last verified: 2019-03

Locations

US (1)