Effect of Omega -3 Fatty Acids Supplements and Plant Sterol Enriched Food in Dyslipidemic Adults
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The incidence of chronic degenerative diseases, especially cardiovascular disease (CVD), is
      high world over and especially in India. High blood cholesterol and triglyceride levels are
      known to be important risk factors for CVD. There is a strong body of evidence for the
      beneficial effects of plant sterols on blood total and LDL-cholesterol and omega-3 fatty
      acids from fish on blood triglycerides. However, the combined benefits of consuming both
      plant sterols and omega-3 fatty acids from fish oil on blood cholesterol and triglycerides
      has not been investigated previously, except in one study where the methodology used was not
      the most appropriate for testing such a combination. In addition, most studies on plant
      sterol efficacy realised so far were done in Western countries. The present study will
      investigate the efficacy of plant sterols and omega-3 fatty acids from fish oil on improving
      the cardiovascular risk profile of Indian adults with dyslipidemia.

      It is expected that, after 4 weeks of intervention, men consuming both plant sterols and
      omega-3 fatty acids from fish oil will have a lower cardiovascular risk profile than men
      receiving only plant sterols or only fish oil or none of these dietary supplements.
    

Detailed description: 
      This study has a double-blind, placebo-controlled, randomized parallel (2 x 2 factorial)
      design with 3 experimental treatments and one control treatment. A two week run-in period
      will be observed during which all subjects will be given placebos for plant sterols.
      Thereafter the subjects will be randomly allocated to the 4 treatment groups for the
      intervention period of 4 weeks and will undergo baseline assessment of blood lipids,
      inflammatory and coagulation markers, anthropometry, lifestyle and dietary habits. The
      intervention period will be closed by repeating measurements of lipids, inflammatory and
      coagulation markers, anthropometry, lifestyle and diet. Participants are mildly
      hypercholesterolemic adult males (TC between 5.0-8.0 mmol/L), aged between 35-55 years who
      are employees of NTPC, Badarpur, New Delhi will be enrolled in the study.

      The subjects will be randomly allocated to the four treatment groups (1 control and 3
      experimental, 50 subjects per group) with the help of computer generated random number
      tables. In case of a surplus of volunteers, a lottery method of selection will be applied.

      The active and control products will be almost identical with respect to taste and appearance
      and will only differ in coding. During the study, the treatment code of the products will be
      blinded and only known by a person not directly involved in the study. The subjects will only
      be identified by a unique identification code given to them at the time of filling their
      interview-schedules. All the information obtained from the subjects will be coded using this
      unique identification code. During the intervention period the key linking subject's names
      and codes will only be accessible to authorized staff.

      For each subject the Investigator and Sponsor will each receive a blinded code envelope with
      details of treatment. In case of an emergency (e.g. Serious Adverse Event possibly related to
      treatments, or unexpected Adverse Events), the envelope can be opened to identify the
      treatment given to a subject. The Investigator and Sponsor will immediately inform each other
      about such de-blinding.

      Randomization data are kept strictly confidential until the time of unblinding. Only after
      the blind review meeting of PI, Investigator and Sponsor, the randomization codes will be
      broken and made available for data analysis.
    

Intervention name(s): Omega 3 fatty acids and plant sterol enriched drink; Omega 3 fatty acids and plant sterols
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Capsules and Yoghurt based minidrink
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dyslipidemia