- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07231367
Effect of Sunflower Seed Consumption on Blood Cholesterol Levels in Adults
"Cholesterol-lowering Potential of Sunflower Seeds: Evidence From Phytochemical and Fatty Acid Composition and a Randomized Human Trial"
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab Province
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Faisalābad, Punjab Province, Pakistan, 38000
- University of Agriculture, Faisalabad
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants included males aged between 40 and 50 years, with serum cholesterol levels exceeding 200 mg/dL, and shared the same socioeconomic status.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
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.
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|
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Experimental: Diseased Group
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
|
Participants consumed sunflower seeds daily for 45 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and 45 days after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
LDL Cholesterol
Time Frame: Baseline and 45 days after intervention
|
LDL cholesterol measured using standard enzymatic methods at baseline and at the end of the 45 days supplementation period.
|
Baseline and 45 days after intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SUNSEED-CHOL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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