DHQ Jhung
Lahore, Punjab Province, 54000, Pakistan
NCT Number: NCT07737067
This study is being conducted at DHQ Hospital, Jhang, under the supervision of the University of Lahore. The purpose of the trial is to find out whether specially prepared cookies made with pumpkin seeds (Cucurbita pepo L.) and walnuts (Juglans regia L.) can help improve cholesterol levels in patients with atherosclerosis.
High cholesterol is one of the major causes of heart disease and stroke. Although medicines are commonly prescribed, adding natural foods with proven health benefits may help patients manage cholesterol in a safer and more affordable way. Pumpkin seeds contain healthy fats, antioxidants, and phytosterols, while walnuts provide omega-3 fatty acids, fiber, and vitamins. Together, they may improve heart health by lowering harmful cholesterol (LDL) and increasing good cholesterol (HDL).
In this study, patients will be divided into two groups:
Treatment group: Will receive one 100 g cookie made with pumpkin seeds and walnuts every day, in addition to their usual care.
Control group: Will receive usual care without the supplemented cookies.
Blood samples will be taken at the start, at 3 weeks, and at 6 weeks to measure cholesterol, triglycerides, LDL, and HDL levels. Researchers will follow up with participants regularly to ensure safety and compliance.
The study will help determine whether these cookies can be recommended as a natural, food-based approach to reducing cholesterol and preventing complications of heart disease.
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Notify Me25 year–45 year
All sexes
Interventional
Not applicable
Lahore, Punjab Province, 54000, Pakistan
Background
Hypercholesterolemia and dyslipidemia are significant modifiable risk factors for atherosclerosis and cardiovascular disease (CVD). Current pharmacological therapies, though effective, are often limited by side effects, cost, and accessibility. Functional foods containing bioactive compounds are gaining attention as adjunct strategies for lipid management.
Pumpkin (Cucurbita pepo L.) seeds are rich in phytosterols, unsaturated fatty acids, magnesium, and antioxidants, all of which may positively influence lipid metabolism. Walnuts (Juglans regia L.) provide polyunsaturated fatty acids (PUFAs), fiber, polyphenols, and essential minerals that have been shown to lower LDL cholesterol and improve endothelial function. Combining these ingredients in an acceptable dietary form may provide synergistic cardioprotective benefits.
Objectives
Primary Objective:
To evaluate the effect of pumpkin seed and walnut-supplemented cookies on serum lipid profile (total cholesterol, LDL, HDL, triglycerides) in patients with atherosclerosis.
Secondary Objectives:
To assess changes in body weight and BMI during the intervention. To monitor acceptability, tolerability, and safety of the supplemented cookies.
Methodology
This is a randomized, controlled interventional study to be conducted at DHQ Hospital, Jhang under the supervision of the University of Lahore.
Study Population: Patients diagnosed with atherosclerosis and hypercholesterolemia.
Sampling Technique: Purposive sampling. Sample Size: \[Insert planned number of participants].
Group Allocation:
Treatment group: Receives one 100 g pumpkin seed and walnut cookie daily for 6 weeks, along with standard medical care.
Control group: Receives standard medical care only. Follow-Up: Baseline, 3rd week, and 6th week laboratory assessments of lipid profile (HDL, LDL, triglycerides, total cholesterol). Regular follow-ups will be conducted using structured datasheets to ensure compliance.
Data Analysis: Pre- and post-intervention outcomes will be compared using appropriate statistical tests.
Expected Outcomes
It is hypothesized that daily supplementation with pumpkin seed and walnut cookies will lead to:
Reduction in total cholesterol and LDL Increase in HDL Improvement in triglyceride levels
Significance
This study will provide evidence on the potential role of functional food supplementation in cardiovascular risk management. If proven effective, the cookie formulation may serve as a cost-effective, culturally acceptable, and safe dietary approach for patients with atherosclerosis in Pakistan and beyond.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients of both gender Patients with age 25-45 years will be included Having HDL value greater than ~60 mg/dL Having triglycerides value greater than150 mg/dL
Exclusion criteria
Pregnant and lactating patients will be excluded. Cancer patient will be excluded
Participants in the intervention group will consume 100 g of cookies supplemented with pumpkin seeds (Cucurbita pepo L.) and walnuts (Juglans regia L.) once daily for 6 weeks. The cookies are prepared with standardized ingredients including whole wheat flour, roasted pumpkin seeds, roasted walnuts, butter, sugar, milk, and baking powder. The supplementation is designed to provide a rich source of polyunsaturated fatty acids, dietary fiber, phytosterols, vitamins, and minerals to support improvement in lipid profile and cardiovascular health.
Participants in the control group will receive conventional medical treatment for hypercholesterolemia and atherosclerosis as prescribed by their physician. No dietary supplementation will be provided.
Time frame: Baseline, 3 weeks, and 6 weeks
Absolute change in serum LDL cholesterol (mg/dL) from baseline to week 6. Blood collected after overnight fast; analyzed by enzymatic methods in hospital lab.
Time frame: Baseline, 3 weeks, and 6 weeks
Absolute change in serum HDL cholesterol (mg/dL) from baseline to week 6. Fasting blood samples analyzed by enzymatic methods.
Kamran Hanif
Other
Acronym: PSW-Cookie
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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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