Effect of Canola oil consumption on the serum lipid profile of dyslipidemic adults- A Study

1. Studyobjectives

 1.1 Primary Objective

To assess the impact ofconsumption of canola oil in regular diet on the serum lipid profile ofdyslipidemic adults.

1.2 SecondaryObjectives

Secondary objectives of thestudy would be:

 1.      To gather data on theexisting 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 benefitanalysis of canola oil intake in terms of its lipid lowering effect.

 These objectives will helpin the establishment of the relationship of other confounding factors withdyslipidemia. For instance, the pattern of waist circumference measurementswith the prevalence of dyslipidemia among individuals or the pattern of dietbeing followed amongst individuals who have high cholesterol levels etc.

 2. Outcomes

2.1.1       Primary outcomeTo find out the extent of change in the lipid profile levels ofdyslipidemic adults post intervention.

2.1.2       Secondary outcomes To find out the relationship of confounding factors (weight,waist circumference, stress) with lipid levels.

 3. methodology:

As stated before, the study is a comparativecontrol pre test post test design prospective study. Other details arespecified below:

 Study location: The study is proposed to be a hospital based study. This will allow theease of data collection that is mainly dependent on biochemical testing.Subjects would be selected from the Preventive Health Check up (PHC) programscarried out at the hospitals on a regular basis. Verbal permission from theconcerned authorities of a private hospital has already been obtained.

 **Participants:**The participants of the research will be selected on the basis of their currentlipoprotein levels as indicated by the health check up reports. Subjects wouldbe dyslipidemic males and females within the age group of 20-55 years.

All the eligible participants will be includedin the study only after clearly stating the aim, purpose and the motive of thestudy. At the end of it, only those who give an informed consent to participatein the study will be selected. Ethical clearance will also be sought from theconcerned authorities.

The participants fulfilling the criteria ofinclusion shall be considered for the intervention study. All the selectedsubjects will be randomly divided into 2 groups on the basis of age and gendermatching- experimental group and control group (It is assumed that the subjectswill 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 beselected 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 whowill be provided with canola oil for their consumption during the interventionperiod along with dietary and lifestyle modification advice.

·        Control group: A group of dyslipidemic adults whowill NOT be provided with any oil to be consumed during the interventionperiod. However, they will be given advice on dietary and lifestylemodification as in the experimental group.

 Baseline data collection:

The baseline data will be collected throughinstruments such as the questionnaire, dietary recall, anthropometricmeasurements, blood pressure, energy expenditure calculation and also thebiochemical tests.

 Run –in period:

This will be followed by a run-in period of a monthwherein the subjects in both the groups will be told to follow the diet andlifestyle modifications as advised to them at the time of enrolment. At the endof 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 thestudy, it was felt that it would not be very practical to prepare foodseparately specially vegetables and curry preparations (although, baghars canbe done for the subject separately). This might cause inconvenience to thefamily which may further lead to a higher dropout rate. Hence, it is proposedthat 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 andauthenticity will be provided on a monthly basis. Further on the basis of therequirement of the subjects/subjects’ family, additional amount of oil may alsobe given. Although, this amount will be given to be used by the whole familyfor the stipulated period, the subjects will be encouraged  and instructed to ensure that the subjectsconsume only the intended oil and no other oil. However, other family memberscan include any other oil in their diet, if they want to. Regular compliancewill be ensured to arrive at valid results. The subjects would be provided witha compliance checklist in which they would record any events of deviation fromthe suggested dietary guidelines e.g. eating out, entertaining guests etc.

Canola oil will be procured in vacuum packedbottles manufactured for the purpose of consumption from Dalmia ContinentalPvt. Limited. The company has agreed to sponsor the required amount of the oil.

Along with the oil substitution, the subjectswill be given advice on dietary and lifestyle modification to be followed inthe consequent intervention period.

 Control group:

The control group will be given appropriateadvice on dietary and lifestyle modifications to be followed in the 3 monthintervention period. They would be given information about healthy food choicesand cooking practices (within their current consumption patterns) though, theywill not be given any oil for consumption.

Both the groups will be provided withappropriate material (pamphlets/leaflets) for advice on dietary and lifestylemodification.

 PHASE III: Post Intervention Phase-

After the completion of the interventionperiod, re collection of the data on the same grounds as the baseline data forboth the groups will be carried out. This will help to study the impact ofsubstituting canola oil in the daily dietary intake with dietary and lifestylemodifications in the experimental group (if any) vis a vis the effect ofmodifying the existing framework of dietary intake with dietary and lifestylemodifications in the control group (Fig 1). The analysis would highlight theextent of change in the lipid profile (if any) after the consumption of canolaoil 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 thedata is collected. The same equipments will be sued for measurements such asheight, weight, waist circumference etc. wherever applicable, they will becalibrated periodically to ensure accuracy. In case of biochemical reportswhich are the mainstay of the study, it will be ensured that all three of thelipid profile tests are done from the same lab to rule out any change ofstandards.