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NCT Number: NCT07610304

Effect of Alpha Tocopherol and Psyllium on Lipid Levels in Dyslipidaemia Patients

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.

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Key information

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tertiary medical centres: Fatima Memorial Hospital, Services Hospital and National Hospital

Lahore, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alpha tocopherol

Dietary Supplement

400 mg Alpha Tocopherol supplement to be taken daily for a duration of 60 days

Other names: Vitamin E

Combination therapy (Alpha Tocopherol and Psyllium husk)

Combination Product

400 mg Alpha Tocopherol taken along with 10 g psyllium daily for duration of 60 days

Other names: Vitamin E, Psyllium

Placebo control

Other

A placebo similar to Vitamin E supplement taken daily for 60 days

Other names: placebo

Primary outcomes

  1. Changes in serum cholesterol and serum triglycerides

    Time frame: From baseline (Day 0) to Day 60

    Changes in serum cholesterol and triglyceride levels is evident from the blood test taken from anti cubital vein performed by a skilled phlebotomist taken at Day 30 and Day 60 (final measurement). An abnormal blood cholesterol measurement is defined as blood cholesterol level greater than 200 mg/day and abnormal blood triglyceride measurement is defined as blood triglyceride level greater than 150 mg/day.

Sponsors and collaborators

Lead sponsor

NUR International University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 27, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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