|
|
Cerum 7™ Study Design:
Study Population:
Overweight Adult Women
Inclusion Criteria: Female
21+ years of age
Desiring to lose 15+ pounds
Willing to use Cerum 7™ consistently for 7 days and/or 4 weeks
and report weekly for study measurements
(weight, body fat, blood pressure, waist/hip/thigh)
Sample Size Assumptions:
Normal Variance:
5 lb. variation in weight loss over a 4-week period.
Difference from Intervention:
5 lb. weight loss over 4 weeks.
Desired level of significance:
95%
Estimate of required sample size:
20 (10 control, 10 intervention)
Enrollment of participants:
See informed consent form
Baseline Examination:
Record weight, blood pressure, body fat, and
Chest/arm/stomach/waist/hip/thigh measurements
for each participant at beginning of trial.
Intervention Allocation:
Random Double Blind
Person A fills 60 identically appearing bottles.
30 with Cerum 7™ and 30 with an inactive simulacrum.
Person A randomly numbers these 60 bottles in pairs,
compiling a list of which number pairs represent each product.
No one else will have access to this list before the trial is concluded.
Person B (licensed nurse and assistant) presents
each trial participant with one (or two) bottle(s),
recording the bottle number given to each.
Trial Design:
Description and Schedule:
On Enrollment Day of trial, each participant will be given
a baseline examination before receiving a bottle(s) of product.
All participants will begin using their product that day (Day 1).
All participants will report for follow up examinations
on Days 7, 14 and 21 and for final examinations on Day 28.
Participants will bring their bottles on these days.
Bottles will be weighed on each of these days to verify
correct levels of usage.
Measure of Compliance:
Participants comply with terms of trial by using product
daily (as verified by weekly weighing of bottles)
and reporting for each weekly examination.
STATEMENT OF INFORMED CONSENT
