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

NCT07610304 | Completed Phase 2

• 1 other identifier: ORIC/IRB/MSFND101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyslipidaemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Changes in serum cholesterol and serum triglycerides

  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.

  From baseline (Day 0) to Day 60

Study Arms (3)

Alpha Tocopherol

ACTIVE COMPARATOR

400 mg alpha tocopherol (Vitamin E) supplement taken daily for a period of 60 days

Dietary Supplement: Alpha tocopherol

Alpha Tocopherol and Psyllium husk

ACTIVE COMPARATOR

Combination Therapy (400 mg Alpha Tocopherol supplementation and 10 g Psyllium husk taken daily for period of 60 days)

Combination Product: Combination therapy (Alpha Tocopherol and Psyllium husk)

Placebo

PLACEBO COMPARATOR

Placebo (look alike supplement similar to active intervention taken daily for period of 60 days)

Other: Placebo Control

Interventions

Alpha tocopherol DIETARY_SUPPLEMENT

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

Also known as: Vitamin E

Alpha Tocopherol

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

Also known as: Vitamin E, Psyllium

Alpha Tocopherol and Psyllium husk

Placebo Control OTHER

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

Also known as: placebo

Placebo

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants' age is between 40 to 60 years
• Total cholesterol ≥200 mg/dL and
• Triglycerides ≥150 mg/dL
• Not receiving lipid-lowering therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• NUR International University: lead

Study Sites (1)

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

Lahore, Pakistan

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

alpha-Tocopherol; Vitamin E; Combined Modality Therapy; Psyllium

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Tocopherols; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start: June 15, 2022
• Primary Completion: August 15, 2022
• Study Completion: August 20, 2022
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)