HypercholesterolemiaPSW-CookieNCT07737067
Alleviation of Hypercholesterolemia Through Newly Developed Cookies Supplementedwithpumpkin (Cucurbita Pepo L.) Seeds and Walnuts (Juglans Regia L.) Among Arthrosclerosispatients.
A study testing Pumpkin Seed and Walnut Cookies in people with Hypercholesterolemia and Arthrosclerosis, run by Kamran Hanif at 1 site in Pakistan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Hypercholesterolemia, Arthrosclerosis
- What is being tested?
- Pumpkin Seed and Walnut Cookies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Sep 2025to 15 Oct 2025
- Phase
- Interventional
- 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 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Pregnant and lactating patients will be excluded. Cancer patient will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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.
Read the detailed description
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.
- Conditions
- Hypercholesterolemia, Arthrosclerosis
- Being tested
- Pumpkin Seed and Walnut Cookies, Standard Care (Control)
- Keywords
- CVD, pumpkin seed,, walnuts, HDL and LDL
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pumpkin Seed and Walnut CookiesDietary supplement
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.
Standard Care (Control)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group - Standard Care | Active comparator | Participants in this group will receive only conventional medical treatment as prescribed by their physician for hypercholesterolemia and atherosclerosis. No additional dietary supplementation (cookies) will be provided. This group serves as the control for comparison with the intervention group. Receives: Other: Standard Care (Control) |
| Intervention Group - Pumpkin Seed and Walnut Cookies | Experimental | Participants in this group will receive conventional medical treatment as prescribed by their physician along with dietary supplementation of 100 g pumpkin seed and walnut cookies once daily for 6 weeks. The cookies are prepared with whole wheat flour, roasted pumpkin seeds, roasted walnuts, sugar, butter, milk, and baking powder in standardized proportions. Blood lipid profile (HDL, LDL, triglycerides, and cholesterol) will be assessed at baseline, 3 weeks, and 6 weeks. Receives: Dietary Supplement: Pumpkin Seed and Walnut Cookies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LDL Cholesterol
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.
Measured: Baseline, 3 weeks, and 6 weeks
Secondary outcomes (1)
hange in HDL Cholesterol
Absolute change in serum HDL cholesterol (mg/dL) from baseline to week 6. Fasting blood samples analyzed by enzymatic methods.
Measured: Baseline, 3 weeks, and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start15 Sep 2025
- Primary completion6 Oct 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kamran Hanif
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lahore
- Responsible party
- Sponsor-investigator, Kamran Hanif, University of Lahore
- Investigators
- Kamran Hanif, Phd, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737067
- Sponsor's protocol ID
- REC-UOL-/547/08/24
- Acronym
- PSW-Cookie
- Status last verified
- Jul 2026
- First submitted
- 25 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: due to privacy concerns
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alleviation of Hypercholesterolemia Through Newly Developed Cookies Supplementedwithpumpkin (Cucurbita Pepo L.) Seeds and Walnuts (Juglans Regia L.) Among Arthrosclerosispatients.
- ClinicalTrials.gov ID
- NCT07737067
- Acronym / sponsor ID
- PSW-Cookie / REC-UOL-/547/08/24
- Conditions
- Hypercholesterolemia, Arthrosclerosis
- Keywords
- CVD, pumpkin seed,, walnuts, HDL and LDL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Kamran HanifUniversity, hospital or other
- Collaborators
- University of Lahore
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 6 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 30 Jul 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group - Standard Care | Active comparator | Other: Standard Care (Control)Participants in this group will receive only conventional medical treatment as prescribed by their physician for hypercholesterolemia and atherosclerosis. No additional dietary supplementation (cookies) will be provided. This group serves as the control for comparison with the intervention group. |
| Intervention Group - Pumpkin Seed and Walnut Cookies | Experimental | Dietary Supplement: Pumpkin Seed and Walnut CookiesParticipants in this group will receive conventional medical treatment as prescribed by their physician along with dietary supplementation of 100 g pumpkin seed and walnut cookies once daily for 6 weeks. The cookies are prepared with whole wheat flour, roasted pumpkin seeds, roasted walnuts, sugar, butter, milk, and baking powder in standardized proportions. Blood lipid profile (HDL, LDL, triglycerides, and cholesterol) will be assessed at baseline, 3 weeks, and 6 weeks. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnant and lactating patients will be excluded. Cancer patient will be excluded
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 |
|---|---|---|
| Pumpkin Seed and Walnut CookiesParticipants 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. | Dietary supplement | Intervention Group - Pumpkin Seed and Walnut Cookies |
| Standard Care (Control)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. | Other | Control Group - Standard Care |
Primary outcome
Change in LDL Cholesterol
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.
1 secondary outcome
hange in HDL Cholesterol
Time frame: Baseline, 3 weeks, and 6 weeks
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 30 Jul 2026.
- Individual participant dataSharing planned: No. due to privacy concerns
Related trials for Hypercholesterolemia
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
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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.
Kamran Hanif, Phd principal investigator
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pumpkin Seed and Walnut Cookies in people with Hypercholesterolemia and Arthrosclerosis, run by Kamran Hanif 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 1 inclusion and 1 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 30 Jul 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change in LDL Cholesterol (time frame: Baseline, 3 weeks, and 6 weeks). 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 30 Jul 2026.