Study of Changes in Total Cholesterol Levels as a Function of Consuming a Supplement Designed to Improve Cardiovascular Health

To evaluate the safety and efficacy of a food-source nutrient by comparing changes in total
cholesterol levels, 44 other blood chemistries, and self-reported quality of life as a
function of consuming two different functional-food supplements versus a placebo in a 60-day
study.

Upon completion of the pre-study screening, and after having received an explanation of the
requirements, risks and benefits, and completing the informed consent interview with the
research coordinator, subjects will execute a written informed consent. Subjects will be
randomly assigned to one of three study groups.

Relevant Background Information.

A factor leading to development of vascular disease, a leading cause of death in
industrialized nations, is elevated serum cholesterol. It is estimated that 19% of Americans
between the ages of 20 and 74 years of age have high serum cholesterol. However, in an
analysis of 10,000 test results in our database from subjects similar to those who are
likely to participate in this study, we found 37% of subjects had TC scores between 200 and
250 and 10.3% above 250.

The most prevalent form of vascular disease is arteriosclerosis, a condition associated with
the thickening and hardening of the arterial wall. The regulation of whole-body cholesterol
homeostasis involves the regulation of intestinal cholesterol absorption, cellular
cholesterol trafficking, a modulation of cholesterol biosynthesis, bile acid biosynthesis,
steroid biosynthesis and the catabolism of the cholesterol-containing plasma lipoproteins.
Regulation of intestinal cholesterol absorption has proven to be an effective means by which
to regulate serum cholesterol levels.

Ad-Chol-Pre (ACP) is a functional food ingredient designed to inhibit cholesterol
absorption. ACP is a freeze dried defatted egg powder containing specific Anti-NPCIL1
(Niemann-Pick C1-like 1) IgY. NPC1L1 is known as a biological target of the
cholesterol-uptake inhibitor, Ezetimibe. In previous unpublished pilot studies examining the
safety and efficacy of ACP include:

- ACP was shown to produce a statistically inhibition of [3H]-Cholesterol absorption from
50 ug/ml (P<0.05) in NPC1L1 over-expressing HepG2 cell lines as compared to an
inhibition of 10ug/ml with Ezetimibe alone.

- I preliminary unpublished animal studies, ACP was shown to significantly inhibit
radiolabelled cholesterol. ACP was found to significantly lower total cholesterol (38%
~56%) and LDL cholesterol (46~57%) in bloods from animals fed who had been fed a high
fat diet for 6 weeks.

Inclusion Criteria:

- be an English-speaking male or female at least 18 years of age;

- have a total cholesterol level between 200 mg/dL and 250mg/dL

- have a LDL level between 100 mg/dL and 160 mg/dL

- not have allergic reactions to eggs or egg products

- not have consumed cholesterol-lowering drugs within 2 months of starting the study

- agree to follow the requirements of the study as set forth in this Informed Consent

- agree to withdraw from the study if becoming pregnant during the study.

Exclusion Criteria:

- do not speak English;

- are under 18 years of age;

- have a total cholesterol level below 200 mg/dL or above 250 mg/dL

- have a LDL level below 100 mg/dL or above 160 mg/dL

- have allergic reactions to eggs or egg products

- have consumed cholesterol-lowering drugs within 2 months of starting the study

- are pregnant or nursing;