NCT03698929

Effect of Dietary Cholesterol on Plasma Lipids

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Physicians Committee for Responsible Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dietary Modification
• Nutritional and Metabolic Disease

Interventions

Type	Name	Description
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.
OTHER	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.

Timeline

• Start date: 2018-09-17
• Primary completion: 2018-11-20
• Completion: 2018-11-20
• First posted: 2018-10-09
• Last updated: 2019-03-20

Locations

1 site across 1 country: United States