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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:
The hypothesis of the study is that 'There is a noticeable difference between all the three study groups.'
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alpha Tocopherol | Active Comparator | 400 mg alpha tocopherol (Vitamin E) supplement taken daily for a period of 60 days |
|
| 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) |
|
| Placebo | Placebo Comparator | Placebo (look alike supplement similar to active intervention taken daily for period of 60 days) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alpha tocopherol | Dietary Supplement | 400 mg Alpha Tocopherol supplement to be taken daily for a duration of 60 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Participants were excluded from the study if they:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tertiary medical centres: Fatima Memorial Hospital, Services Hospital and National Hospital | Lahore | Pakistan |
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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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D024502 | alpha-Tocopherol |
| D014810 | Vitamin E |
| D003131 | Combined Modality Therapy |
| D011620 | Psyllium |
| ID | Term |
|---|---|
| D024505 | Tocopherols |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| 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 |
|
|
| Placebo Control | Other | A placebo similar to Vitamin E supplement taken daily for 60 days |
|
|
| D006571 |
| Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013812 | Therapeutics |
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |