DyslipidaemiaPhase 2NCT07610304
Effect of Alpha Tocopherol and Psyllium on Lipid Levels in Dyslipidaemia Patients
A Phase 2 study testing Alpha tocopherol and Combination therapy (Alpha Tocopherol and Psyllium husk) in people with Dyslipidaemia, run by NUR International University at 1 site in Pakistan.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Dyslipidaemia
- What is being tested?
- Alpha tocopherol and Combination therapy (Alpha Tocopherol and Psyllium husk)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2022to 20 Aug 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants' age is between 40 to 60 years
- Total cholesterol ≥200 mg/dL and
- Triglycerides ≥150 mg/dL
- Not receiving lipid-lowering therapy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Tertiary medical centres: Fatima Memorial Hospital, Services Hospital and National Hospital
Lahore
About this study
Official 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
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:
Read more
- 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.
Read the 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.
- Conditions
- Dyslipidaemia
- Being tested
- Alpha tocopherol, Combination therapy (Alpha Tocopherol and Psyllium husk), Placebo Control
- Keywords
- Alpha tocopherol, Psyllium, Double Blind Randomized Control Trial, Dyslipidaemia
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha tocopherolDietary supplement
Also called Vitamin E
400 mg Alpha Tocopherol supplement to be taken daily for a duration of 60 days
Combination therapy (Alpha Tocopherol and Psyllium husk)Combination product
Also called Vitamin E, Psyllium
400 mg Alpha Tocopherol taken along with 10 g psyllium daily for duration of 60 days
Placebo ControlOther
Also called placebo
A placebo similar to Vitamin E supplement taken daily for 60 days
| Study group | Role | What they receive |
|---|---|---|
| Alpha Tocopherol | Active comparator | 400 mg alpha tocopherol (Vitamin E) supplement taken daily for a period of 60 days Receives: 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) Receives: 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) Receives: Other: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline (Day 0) to Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start15 Jun 2022
- Primary completion15 Aug 2022
- Study completion20 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- NUR International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehreen Hassan, NUR International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610304
- Sponsor's protocol ID
- ORIC/IRB/MSFND101
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to breach of privacy and confidentiality considerations as consent form was given to participants prior to the study enrollment in which they were informed that their information will remain confidential.
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07610304
- Acronym / sponsor ID
- ORIC/IRB/MSFND101
- Conditions
- Dyslipidaemia
- Keywords
- Alpha tocopherol, Psyllium, Double Blind Randomized Control Trial, Dyslipidaemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- NUR International UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 20 Aug 2022 (actual)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alpha Tocopherol | Active comparator | Dietary Supplement: Alpha tocopherol400 mg alpha tocopherol (Vitamin E) supplement taken daily for a period of 60 days |
| Alpha Tocopherol and Psyllium husk | Active comparator | Combination Product: Combination therapy (Alpha Tocopherol and Psyllium husk)Combination Therapy (400 mg Alpha Tocopherol supplementation and 10 g Psyllium husk taken daily for period of 60 days) |
| Placebo | Placebo comparator | Other: Placebo ControlPlacebo (look alike supplement similar to active intervention taken daily for period of 60 days) |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants' age is between 40 to 60 years
- Total cholesterol ≥200 mg/dL and
- Triglycerides ≥150 mg/dL
- Not receiving lipid-lowering therapy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha tocopherolAlso: Vitamin E400 mg Alpha Tocopherol supplement to be taken daily for a duration of 60 days | Dietary supplement | Alpha Tocopherol |
| Combination therapy (Alpha Tocopherol and Psyllium husk)Also: Vitamin E, Psyllium400 mg Alpha Tocopherol taken along with 10 g psyllium daily for duration of 60 days | Combination product | Alpha Tocopherol and Psyllium husk |
| Placebo ControlAlso: placeboA placebo similar to Vitamin E supplement taken daily for 60 days | Other | Placebo |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to breach of privacy and confidentiality considerations as consent form was given to participants prior to the study enrollment in which they were informed that their information will remain confidential.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alpha tocopherol and Combination therapy (Alpha Tocopherol and Psyllium husk) in people with Dyslipidaemia, run by NUR International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in serum cholesterol and serum triglycerides (time frame: From baseline (Day 0) to Day 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.