Effect Of Alpha Tocopherol Supplementation Alone And In Combination With Psyllium On Serum Lipids In Patients With Dyslipidaemia In Lahore: A Double Blind, Placebo Controlled, Parallel Randomized Control Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
Study Overview
Brief Summary
The goal of this clinical trial is to find out whether Vitamin E (Alpha tocopherol), taken alone or together with Psyllium husk (a type of dietary fibre), can improve blood fat levels in adults with dyslipidaemia (abnormal blood levels of two types of fat: cholesterol and triglycerides).
The main questions this study aims to answer are:
- Does Vitamin E (400 mg/day) alone help lower blood cholesterol and triglyceride levels?
- Does combining Vitamin E (400 mg/day) with Psyllium husk (10 g/day) lead to better results compared to participants taking Vitamin E alone? Researchers will compare all three groups i.e. Group A taking Vitamin E alone, Group B taking Vitamin E and Psyllium husk and Group C receiving a placebo (a look alike supplement).
The hypothesis of the study is that 'There is a noticeable difference between all the three study groups.'
Participants will:
- Take their assigned (specific to the concerned group under study) treatment daily for 60 days.
- Visit study place every two weeks for follow-up.
- Have blood tests done at the beginning and end of the study to check for changes in cholesterol and triglyceride levels.
Detailed Description
The present study is a randomized, double-blind, placebo controlled clinical trial which was conducted to check for any improvement in serum cholesterol and triglyceride levels of patients after giving them intervention through alpha tocopherol alone and combination therapy (alpha tocopherol and psyllium) for 60 days. There is an increasing prevalence of dyslipidaemia especially in developing countries such as Pakistan in which unhealthy food consumption combined with sedentary lifestyle has led to increased levels of total blood cholesterol and triglycerides known as dyslipidaemia. Dyslipidaemia is a risk factor contributing to progression of cardiovascular disease. Dietary supplements such as psyllium husk and antioxidants such as Vitamin E are known to improve blood lipid profile levels in patients receiving this therapy.60 participants after meeting inclusion criteria for the study were randomly assigned into three study groups using computer generated: Group A participants treated with alpha-tocopherol, Group B participants treated with combination therapy and Group C receiving a placebo. Statistical analysis was done using two-way ANOVA and Bonferroni. Level of significance 'p value' < 0.05 is considered statistically significant whereas for Bonferroni, level of significance 'p value' <0.167 is considered statistically significant.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants' age is between 40 to 60 years
- •Total cholesterol ≥200 mg/dL and
- •Triglycerides ≥150 mg/dL
- •Not receiving lipid-lowering therapy
Exclusion Criteria
- •Participants were excluded from the study if they:
- •Had any other non-communicable disease (e.g. uncontrolled diabetes, cardiovascular disease, or chronic kidney disease)
- •Were using statins, fibrates, beta-blockers, or antioxidant supplements
- •Had Familial hyperlipidemia
Investigators
Mehreen Hassan
Researcher
NUR International University