1. Study
objectives
1.1 Primary Objective
To assess the impact of
consumption of canola oil in regular diet on the serum lipid profile of
dyslipidemic adults.
1.2 Secondary
Objectives
Secondary objectives of the
study would be:
1. To gather data on the
existing dietary practices and food preferences of the target population.
2. To collect data on height,
weight, waist circumference and blood pressure of the participants.
3. To do a cost benefit
analysis of canola oil intake in terms of its lipid lowering effect.
These objectives will help
in the establishment of the relationship of other confounding factors with
dyslipidemia. For instance, the pattern of waist circumference measurements
with the prevalence of dyslipidemia among individuals or the pattern of diet
being followed amongst individuals who have high cholesterol levels etc.
2. Outcomes
To find out the extent of change in the lipid profile levels of
dyslipidemic adults post intervention.
To find out the relationship of confounding factors (weight,
waist circumference, stress) with lipid levels.
3. methodology:
As stated before, the study is a comparative
control pre test post test design prospective study. Other details are
specified below:
Study location: The study is proposed to be a hospital based study. This will allow the
ease of data collection that is mainly dependent on biochemical testing.
Subjects would be selected from the Preventive Health Check up (PHC) programs
carried out at the hospitals on a regular basis. Verbal permission from the
concerned authorities of a private hospital has already been obtained.
Participants:
The participants of the research will be selected on the basis of their current
lipoprotein levels as indicated by the health check up reports. Subjects would
be dyslipidemic males and females within the age group of 20-55 years.
All the eligible participants will be included
in the study only after clearly stating the aim, purpose and the motive of the
study. At the end of it, only those who give an informed consent to participate
in the study will be selected. Ethical clearance will also be sought from the
concerned authorities.
The participants fulfilling the criteria of
inclusion shall be considered for the intervention study. All the selected
subjects will be randomly divided into 2 groups on the basis of age and gender
matching- experimental group and control group (It is assumed that the subjects
will be of the same demographic profile i.e. having same SES and lifestyle).
The study would be carried out in three phases.
The proposed procedure of the research is explained below:
PHASE I: Pre - intervention Phase-
Selection of the sample:
The subjects (dyslipidemic adults) will be
selected on the basis of the criteria discussed further They will be randomized
into two groups- experimental and control.
The grouping will be as follows:
·
Experimental group: A group of dyslipidemic adults who
will be provided with canola oil for their consumption during the intervention
period along with dietary and lifestyle modification advice.
·
Control group: A group of dyslipidemic adults who
will NOT be provided with any oil to be consumed during the intervention
period. However, they will be given advice on dietary and lifestyle
modification as in the experimental group.
Baseline data collection:
The baseline data will be collected through
instruments such as the questionnaire, dietary recall, anthropometric
measurements, blood pressure, energy expenditure calculation and also the
biochemical tests.
Run –in period:
This will be followed by a run-in period of a month
wherein the subjects in both the groups will be told to follow the diet and
lifestyle modifications as advised to them at the time of enrolment. At the end
of the run-in period, re-assessment of the lipoprotein levels would be done.
The intervention would commence only at the end of the run-in period.
PHASE II: Intervention Phase-
Experimental Group:
All the subjects will be given a 3 month supply of oil. Although,
initially, it was planned that the supply would be only for the subjects of the
study, it was felt that it would not be very practical to prepare food
separately specially vegetables and curry preparations (although, baghars can
be done for the subject separately). This might cause inconvenience to the
family which may further lead to a higher dropout rate. Hence, it is proposed
that the oil will be supplied for the consumption of the family as well.
Initially, 2 litres of oil in proper vacuum packaging to ensure purity and
authenticity will be provided on a monthly basis. Further on the basis of the
requirement of the subjects/subjects’ family, additional amount of oil may also
be given. Although, this amount will be given to be used by the whole family
for the stipulated period, the subjects will be encouraged and instructed to ensure that the subjects
consume only the intended oil and no other oil. However, other family members
can include any other oil in their diet, if they want to. Regular compliance
will be ensured to arrive at valid results. The subjects would be provided with
a compliance checklist in which they would record any events of deviation from
the suggested dietary guidelines e.g. eating out, entertaining guests etc.
Canola oil will be procured in vacuum packed
bottles manufactured for the purpose of consumption from Dalmia Continental
Pvt. Limited. The company has agreed to sponsor the required amount of the oil.
Along with the oil substitution, the subjects
will be given advice on dietary and lifestyle modification to be followed in
the consequent intervention period.
Control group:
The control group will be given appropriate
advice on dietary and lifestyle modifications to be followed in the 3 month
intervention period. They would be given information about healthy food choices
and cooking practices (within their current consumption patterns) though, they
will not be given any oil for consumption.
Both the groups will be provided with
appropriate material (pamphlets/leaflets) for advice on dietary and lifestyle
modification.
PHASE III: Post Intervention Phase-
After the completion of the intervention
period, re collection of the data on the same grounds as the baseline data for
both the groups will be carried out. This will help to study the impact of
substituting canola oil in the daily dietary intake with dietary and lifestyle
modifications in the experimental group (if any) vis a vis the effect of
modifying the existing framework of dietary intake with dietary and lifestyle
modifications in the control group (Fig 1). The analysis would highlight the
extent of change in the lipid profile (if any) after the consumption of canola
oil and thereby ascertain if the high cost of canola oil is justified.
As far as the collection of data is concerned,
it would be ensured that there is a uniformity and consistency in the way the
data is collected. The same equipments will be sued for measurements such as
height, weight, waist circumference etc. wherever applicable, they will be
calibrated periodically to ensure accuracy. In case of biochemical reports
which are the mainstay of the study, it will be ensured that all three of the
lipid profile tests are done from the same lab to rule out any change of
standards.
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