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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07610304
Enrollment
60
Registered
2026-05-27
Start date
2022-06-15
Completion date
2022-08-20
Last updated
2026-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidaemia

Keywords

Alpha tocopherol, Psyllium, Double Blind Randomized Control Trial, Dyslipidaemia

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.

Interventions

DIETARY_SUPPLEMENTAlpha tocopherol

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

COMBINATION_PRODUCTCombination therapy (Alpha Tocopherol and Psyllium husk)

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

OTHERPlacebo Control

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

Sponsors

NUR International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Changes in serum cholesterol and serum triglyceridesFrom baseline (Day 0) to Day 60Changes 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 28, 2026