Manuscript Proposal Template

Date: ___________________
Title:_______________________________________________________________________
______________________________________________________________________
Proposing Investigator: _______________________________________________________
Address (if not DPM): _________________________________________________________
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SAMPLE PROPOSAL
PROVIDED TO ASSIST IN THE DEVELOPMENT OF NEW PROPOSALS

Correlates of serum lycopene in older women
(Example of MS proposal with all the required elements)
RATIONALE (2-3 paragraphs)
Over the past decade, increasing interest has been focused on the role of antioxidant nutrients in disease prevention.  The carotenoid pigments, which number over 500, are well known for their antioxidant properties. Only b-carotene has been studied extensively; the other major
carotenoids found in the human body have garnered much less attention.  Of this group, lycopene is particularly important because it comprises roughly half the total carotenoid concentration of human serum.  Dietary lycopene is primarily derived from tomatoes and tomato products.

Although research conducted over the past 8 years suggests that lycopene may play an important role in disease prevention, there is little information about predictors of serum lycopene.  It is the only major carotenoid found to decrease with age and does not appear to be higher in women than men, as are other carotenoids, thus, lycopene status may be particularly important in older women. By investigating the factors associated with serum lycopene in a subset of older women, a better understanding of the relationship between this potentially important nutrient and certain disease processes may be gained.

OBJECTIVES

1.   To evaluate the relationship of serum lycopene with dietary lycopene intake, foods high in lycopene and other dietary factors as estimated by the baseline FFQ.

2.   To assess the relationship of serum lycopene with lifestyle, demographic, and biochemical factors of WHI participants at baseline.

The ethnic diversity of the WHI also offers a unique opportunity to study the determinants of serum lycopene among the various ethnic groups.

KEY EXPOSURE VARIABLES:

age
ethnicity
BMI
smoking
alcohol intake
lycopene intake
total caloric intake

KEY OUTCOME VARIABLES:

serum lycopene

ANALYSIS PLAN (brief description)

We propose to analyze baseline data from CT participants in the 6% serum subsample whose blood samples have been analyzed.  We will describe the intake and serum concentration of lycopene according to demographic characteristics of the study population. We will examine the relationship between serum lycopene and other factors using Pearson correlation coefficients and multiple linear regression. For factors that are found to be associated with serum lycopene, e.g. lycopene intake, we will test for modification of the effect by age, ethnicity, and smoking status (current, former, or never).  If any of the findings differ by these variables, the results will be stratified by these variables.

TABLES

Table 1.  Demographic and physiologic characteristics
Variable	Mean or percentage	SD Serum lycopene
Lycopene intake
Total caloric intake
Select demographic variables
.
.
.

Table 2.  Pearson correlations (r) of serum lycopene with dietary estimates, blood measures, and personal characteristics
Serum Lycopene
Variable	Crude	Adjusted
2
.
.
.
22

Table 3.  Multivariate regression analysis of serum lycopene on physiologic and personal characteristics
Independent Variable	Regression Coefficient	Standard Error	Significance
(Intercept)

R2=