HypercholesterolemiaNCT07231367
Effect of Sunflower Seed Consumption on Blood Cholesterol Levels in Adults
A study testing Sunflower Seed Supplementation in people with Hypercholesterolemia, run by University of Faisalabad at 1 site in Pakistan.
Trial summary
This study evaluates the effect of daily consumption of sunflower seeds on blood cholesterol levels in adult participants. Participants were randomly assigned to consume a specified amount of sunflower seeds for a defined period, and their blood cholesterol and lipid profile were measured before and after the… Read more about this study
- Who is it for?
- Ages 40 to 50 years, men only
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Sunflower Seed Supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Jul 2023to 20 Aug 2023
- 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 40 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Participants included males aged between 40 and 50 years, with serum cholesterol levels exceeding 200 mg/dL, and shared the same socioeconomic status.
Who cannot join
- The participants were excluded based on different physiological factors, such as active smokers, alcoholics, chronic disease patients, people having extremely low or high BMI, people suffering from psychological disorders or familial hypercholesterolemia, people who belong to a high-income group, and people having doubts or confusion while following instructions
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
University of Agriculture, Faisalabad
Faisalābad, Punjab Province, 38000
About this study
Official title: "Cholesterol-lowering Potential of Sunflower Seeds: Evidence From Phytochemical and Fatty Acid Composition and a Randomized Human Trial"
This study evaluates the effect of daily consumption of sunflower seeds on blood cholesterol levels in adult participants. Participants were randomly assigned to consume a specified amount of sunflower seeds for a defined period, and their blood cholesterol and lipid profile were measured before and after the intervention. The study aims to determine whether sunflower seeds can contribute to improving cardiovascular health by lowering cholesterol. Adult men and women meeting the eligibility criteria were included in the study. The findings may help inform dietary recommendations for managing cholesterol and promoting heart health.
Read the detailed description
This randomized, open-label human trial evaluated the cholesterol-lowering potential of sunflower seeds in adult participants. Eligible men and women were recruited based on inclusion criteria, which included age range, baseline cholesterol levels, and absence of major health conditions. Participants were randomly assigned to consume a defined daily portion of sunflower seeds for a specified intervention period. Blood samples were collected at baseline and at the end of the intervention to measure total cholesterol, LDL-C, HDL-C, triglycerides, and other relevant lipid parameters.
Prior to the human intervention, sunflower seeds were analyzed for their nutritional composition, mineral content, phytochemical profile, and fatty acid composition using standard laboratory procedures. Tests included proximate analysis (moisture, protein, fat, ash, and carbohydrate content), mineral quantification (calcium, magnesium, potassium, etc.), phytochemical assays (total phenolics, flavonoids), and fatty acid profiling using gas chromatography. These analyses provided a detailed characterization of the seeds' bioactive components relevant to cardiovascular health.
The study also included assessments of dietary intake, anthropometric measurements, and adherence to the intervention. The primary objective was to determine the effect of sunflower seed consumption on blood cholesterol levels, while secondary objectives included evaluating changes in lipid profile and potential associations with bioactive components of the seeds. Data were analyzed using standard statistical methods. The results aim to provide evidence on the role of sunflower seeds in cardiovascular risk management and to inform dietary recommendations.
- Conditions
- Hypercholesterolemia
- Being tested
- Sunflower Seed Supplementation
- Keywords
- Sunflower seeds, Hypercholesterolemia, Cholesterol, Phytochemicals
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunflower Seed SupplementationDietary supplement
Participants consumed sunflower seeds daily for 45 days
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants continued their usual diet without consuming sunflower seeds. Blood cholesterol and lipid profiles were measured at baseline and at the end of the study period. |
| Diseased Group | Experimental | Participants consumed a defined daily portion of sunflower seeds for the duration of the study. Blood samples were collected at baseline and after the intervention to measure total cholesterol, LDL-C, HDL-C, triglycerides, and other lipid parameters. Dietary intake and adherence to the intervention were monitored throughout the study period Receives: Dietary Supplement: Sunflower Seed Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Cholesterol
Total serum cholesterol measured using standard enzymatic methods at baseline and at the end of the 45 days sunflower seed supplementation period.
Measured: Baseline and 45 days after intervention
Secondary outcomes (1)
LDL Cholesterol
LDL cholesterol measured using standard enzymatic methods at baseline and at the end of the 45 days supplementation period.
Measured: Baseline and 45 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start5 Jul 2023
- Primary completion20 Aug 2023
- Study completion20 Aug 2023
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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amna Butt, University of Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231367
- Sponsor's protocol ID
- SUNSEED-CHOL
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study was completed prior to an IPD sharing plan, and participant consent did not include sharing of individual-level data.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Cholesterol-lowering Potential of Sunflower Seeds: Evidence From Phytochemical and Fatty Acid Composition and a Randomized Human Trial"
- ClinicalTrials.gov ID
- NCT07231367
- Acronym / sponsor ID
- SUNSEED-CHOL
- Conditions
- Hypercholesterolemia
- Keywords
- Sunflower seeds, Hypercholesterolemia, Cholesterol, Phytochemicals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of FaisalabadUniversity, hospital or other
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 20 Aug 2023 (actual)
- Study completion
- 20 Aug 2023 (actual)
- First posted
- 17 Nov 2025 (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 evaluates the effect of daily consumption of sunflower seeds on blood cholesterol levels in adult participants. Participants were randomly assigned to consume a specified amount of sunflower seeds for a defined period, and their blood cholesterol and lipid profile were measured before and after the intervention. The study aims to determine whether sunflower seeds can contribute to improving cardiovascular health by lowering cholesterol. Adult men and women meeting the eligibility criteria were included in the study. The findings may help inform dietary recommendations for managing cholesterol and promoting heart health.
Detailed description
This randomized, open-label human trial evaluated the cholesterol-lowering potential of sunflower seeds in adult participants. Eligible men and women were recruited based on inclusion criteria, which included age range, baseline cholesterol levels, and absence of major health conditions. Participants were randomly assigned to consume a defined daily portion of sunflower seeds for a specified intervention period. Blood samples were collected at baseline and at the end of the intervention to measure total cholesterol, LDL-C, HDL-C, triglycerides, and other relevant lipid parameters.
Prior to the human intervention, sunflower seeds were analyzed for their nutritional composition, mineral content, phytochemical profile, and fatty acid composition using standard laboratory procedures. Tests included proximate analysis (moisture, protein, fat, ash, and carbohydrate content), mineral quantification (calcium, magnesium, potassium, etc.), phytochemical assays (total phenolics, flavonoids), and fatty acid profiling using gas chromatography. These analyses provided a detailed characterization of the seeds' bioactive components relevant to cardiovascular health.
The study also included assessments of dietary intake, anthropometric measurements, and adherence to the intervention. The primary objective was to determine the effect of sunflower seed consumption on blood cholesterol levels, while secondary objectives included evaluating changes in lipid profile and potential associations with bioactive components of the seeds. Data were analyzed using standard statistical methods. The results aim to provide evidence on the role of sunflower seeds in cardiovascular risk management and to inform dietary recommendations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants continued their usual diet without consuming sunflower seeds. Blood cholesterol and lipid profiles were measured at baseline and at the end of the study period. |
| Diseased Group | Experimental | Dietary Supplement: Sunflower Seed SupplementationParticipants consumed a defined daily portion of sunflower seeds for the duration of the study. Blood samples were collected at baseline and after the intervention to measure total cholesterol, LDL-C, HDL-C, triglycerides, and other lipid parameters. Dietary intake and adherence to the intervention were monitored throughout the study period |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants included males aged between 40 and 50 years, with serum cholesterol levels exceeding 200 mg/dL, and shared the same socioeconomic status.
Key exclusion criteria (1 listed)
- The participants were excluded based on different physiological factors, such as active smokers, alcoholics, chronic disease patients, people having extremely low or high BMI, people suffering from psychological disorders or familial hypercholesterolemia, people who belong to a high-income group, and people having doubts or confusion while following instructions
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 |
|---|---|---|
| Sunflower Seed SupplementationParticipants consumed sunflower seeds daily for 45 days | Dietary supplement | Diseased Group |
Primary outcome
Change in Total Cholesterol
Time frame: Baseline and 45 days after intervention
Total serum cholesterol measured using standard enzymatic methods at baseline and at the end of the 45 days sunflower seed supplementation period.
1 secondary outcome
LDL Cholesterol
Time frame: Baseline and 45 days after intervention
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 17 Nov 2025.
- Individual participant dataSharing planned: No. The study was completed prior to an IPD sharing plan, and participant consent did not include sharing of individual-level data.
Related trials for Hypercholesterolemia
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
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Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
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 study testing Sunflower Seed Supplementation in people with Hypercholesterolemia, run by University of Faisalabad 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 17 Nov 2025. 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 Total Cholesterol (time frame: Baseline and 45 days after intervention). 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 17 Nov 2025.