HyperlipidemiaNCT07123844
Pumpkin Seeds or Oil Lower Serum Triglyceride Levels in Individuals With Hyperlipidaemia
A study testing low cholesterol diet in people with Hyperlipidemia and Overweight, run by Kastamonu University at 1 site in Turkey (Türkiye).
Trial summary
Aim of the Study: This randomized controlled experimental study aimed to evaluate the effects of cholesterol-restricted diets enriched with pumpkin seeds and pumpkin seed oil on cardiovascular risk factors-specifically serum lipid profile (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides), blood… Read more about this study
- Who is it for?
- Ages 19 to 64 years
- Conditions the study is for
- Hyperlipidemia, Overweight
- What is being tested?
- low cholesterol diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 3 Nov 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 19 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants must meet all of the following criteria:
- Aged between 19 and 64 years
- Body mass index (BMI) between 25.0 and 30.0 kg/m²
- Triglyceride (TG) level > 200 mg/dL
- Low-density lipoprotein cholesterol (LDL-C) between 130 and 190 mg/dL
- Fasting blood glucose < 110 mg/dL
- Blood pressure below 140/90 mmHg
Who cannot join
- Individuals will be excluded if they meet any of the following criteria:
- Diagnosis of any systemic disease, including:
- Diabetes mellitus
- Hypertension
- Cancer
- Metabolic syndrome
Show all 13Show fewer
- Chronic kidney disease
- Use of any medication that affects blood lipid, glucose, and pressure levels
- Presence of food allergies (e.g., to pumpkin seeds or oil)
- Current or recent nutritional treatment or dietary therapy
- Pregnancy or breastfeeding
- Diagnosed psychiatric disorders
- Known congenital metabolic disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kastamonu Training and Research Hospital
Kastamonu, 37100
About this study
Official title: The Effects of Cholesterol-Restricted Diets Enriched With Pumpkin Seeds and Pumpkin Seed Oil on Cardiovascular Risk Factors in Individuals With Hyperlipidaemia
Aim of the Study:
This randomized controlled experimental study aimed to evaluate the effects of cholesterol-restricted diets enriched with pumpkin seeds and pumpkin seed oil on cardiovascular risk factors-specifically serum lipid profile (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides), blood pressure, and anthropometric measurements (body weight, body mass index, body fat percentage, and fat mass)-in individuals with hyperlipidemia.
Read more
Research Questions:
Does the nutritional intervention lead to a reduction in serum total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and triglyceride (TG) levels, as well as an increase in high-density lipoprotein cholesterol (HDL-C) levels across all study groups?
Do the groups receiving diets enriched with pumpkin seeds or pumpkin seed oil show greater improvements in lipid profile (TC, LDL-C, TG) and a more pronounced increase in HDL-C compared to the control group?
Does the nutritional intervention result in reductions in body weight, BMI, body fat percentage, and fat mass in all study groups?
Read the detailed description
The aim of this randomized controlled trial was to investigate the effects of cholesterol-restricted diets enriched with pumpkin seeds or pumpkin seed oil on cardiovascular risk factors in individuals with hyperlipidemia. Specifically, the study aimed to determine the effects of these dietary interventions on serum lipid parameters (total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides), blood pressure (systolic and diastolic), and anthropometric measurements (body weight, body mass index, body fat percentage, and fat mass) over a 28-day period.
The study hypothesizes that incorporating pumpkin seeds or pumpkin seed oil into a cholesterol-restricted diet will improve serum lipid parameters and blood pressure, and reduce anthropometric measurements.
Research Questions:
Primary Questions:
Does consumption of a cholesterol-restricted diet in individuals with hyperlipidemia result in statistically significant improvements in the serum lipid profile (i.e., decreases in TC, LDL-C, and TG, and increases in HDL-C)?
Do diets enriched with pumpkin seeds or pumpkin seed oil lead to greater improvements in these lipid parameters compared to a control group that only follows a cholesterol-restricted diet?
Secondary Questions:
Does the intervention (regardless of group) lead to reductions in anthropometric indices such as body weight, BMI, body fat percentage, and fat mass?
Are reductions in anthropometric measurements and improvements in blood pressure more pronounced in groups consuming diets enriched with pumpkin seeds or pumpkin seed oil compared to the control group?
- Conditions
- Hyperlipidemia, Overweight
- Being tested
- low cholesterol diet
- Keywords
- overweight, pumpkin seed, pumpkin seed oil, nutritional treatment, functional food, hyperlipidemia, serum lipids
- Medical subject headings
- Hyperlipidemias, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low cholesterol dietDietary supplement
low cholesterol diet
| Study group | Role | What they receive |
|---|---|---|
| pumpkin seed | Experimental | 30 g/day pumpkin seed and low cholesterol diet (28 days) Receives: Dietary Supplement: low cholesterol diet |
| pumpkin seed oil | Experimental | 15 g/day pumpkin seed oil and low cholesterol diet (28 days) Receives: Dietary Supplement: low cholesterol diet |
| control | Experimental | low cholesterol diet (28 days) Receives: Dietary Supplement: low cholesterol diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Total Cholesterol (mg/dL) from Baseline to Day 28
Measured from 12-hour fasting venous blood samples using enzymatic colorimetric methods on an automated analyzer. Reference ranges per Turkish Society of Endocrinology and Metabolism (TEMD) Dyslipidemia Guidelines, 2021: desirable <200 mg/dL, borderline high 200-239 mg/dL, high ≥240 mg/dL.
Measured: Baseline and Day 28
Change in Serum LDL-Cholesterol (mg/dL) from Baseline to Day 28
Calculated using the Friedewald formula from fasting lipid profile. Reference ranges per TEMD, 2021: optimal <100 mg/dL (or <70 mg/dL for very high cardiovascular risk), borderline high 130-159 mg/dL, high 160-189 mg/dL, very high ≥190 mg/dL.
Measured: Baseline and Day 28
Change in Serum HDL-Cholesterol (mg/dL) from Baseline to Day 28
Measured from fasting venous blood using enzymatic methods. Reference ranges per TEMD, 2021: low HDL <40 mg/dL in men and <50 mg/dL in women; protective ≥60 mg/dL.
Measured: Baseline and Day 28
Change in Serum Triglycerides (mg/dL) from Baseline to Day 28
Measured from fasting venous blood using enzymatic methods. Reference ranges per TEMD, 2021: normal <150 mg/dL, borderline high 150-199 mg/dL, high 200-499 mg/dL, very high ≥500 mg/dL.
Measured: Baseline and Day 28
Secondary outcomes (9)
Change in Body Weight (kg) from Baseline to Day 28
Measured without shoes and in light clothing using a Tanita TBF-300 bioelectrical impedance analyzer (BIA).
Measured: Baseline and Day 28
Height (m) at Baseline
Measured using a Densi GL 150 stadiometer.
Measured: Baseline
Change in Body Mass Index (kg/m²) from Baseline to Day 28
Calculated as body weight (kg) divided by height squared (m²). Classification per World Health Organization (WHO): normal 18.5-24.9, overweight 25.0-29.9, obese ≥30.0.
Measured: Baseline and Day 28
Change in Body Fat Percentage (%) from Baseline to Day 28
Measured using a Tanita TBF-300 BIA.
Measured: Baseline and Day 28
Change in Fat Mass (kg) from Baseline to Day 28
Measured using a Tanita TBF-300 BIA.
Measured: Baseline and Day 28
Change in Systolic Blood Pressure (mmHg) from Baseline to Day 28
Measured in seated position after 5 minutes of rest using an automated sphygmomanometer. Two readings taken 1-2 minutes apart; average recorded. Reference ranges per ESC/ESH Guidelines, 2018: normal <120 mmHg; elevated 120-139 mmHg.
Measured: Baseline and Day 28
Change in Diastolic Blood Pressure (mmHg) from Baseline to Day 28
Same procedure as systolic BP measurement. Reference ranges per ESC/ESH Guidelines, 2018: normal <80 mmHg; elevated 80-89 mmHg.
Measured: Baseline and Day 28
Change in Dietary Energy and Nutrient Intake (kcal/day, g/day, mg/day) from Baseline to Day 28
Assessed by 3-day food records (two weekdays and one weekend day). Data analyzed using the Nutrition Information System (BeBİS, version 7.2). Results compared with recommended daily intakes in the Turkish Nutrition Guide (TÜBER, 2022).
Measured: Baseline and Day 28
Change in Food Group Consumption Frequency (times/week) from Baseline to Day 28
Evaluated using a structured dietary habits questionnaire. Frequency data categorized by major food groups and analyzed for change over time.
Measured: Baseline and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start1 Jun 2022
- Primary completion30 Sep 2023
- Study completion3 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiaStudies 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
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kastamonu University
- Sponsor type
- University, hospital or other
- Collaborators
- Okan University
- Responsible party
- Principal investigator, Kevser Karli, Kastamonu University
- Investigators
- Hande Öngün Yılmaz, pHD, Study director, hyilmaz@bandirma.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07123844
- Sponsor's protocol ID
- 2022--KAEK-37
- Status last verified
- Aug 2025
- First submitted
- 30 Jul 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol and informed consent form will be shared with other researchers upon request. However, no individual participant data (IPD) such as de-identified participant-level health data will be shared. The shared documents will not include any personal or outcome data of participants.
Publications
Karli K, Yilmaz HO, Incaman D. Pumpkin seed and seed oil affect triglyceride levels in adults with hyperlipidemia: a randomized controlled trial. Ir J Med Sci. 2026 Oct 28. doi: 10.1007/s11845-026-04706-3. Online ahead of print.
PubMed 42955537
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cholesterol-Restricted Diets Enriched With Pumpkin Seeds and Pumpkin Seed Oil on Cardiovascular Risk Factors in Individuals With Hyperlipidaemia
- ClinicalTrials.gov ID
- NCT07123844
- Acronym / sponsor ID
- 2022--KAEK-37
- Conditions
- Hyperlipidemia, Overweight
- Keywords
- overweight, pumpkin seed, pumpkin seed oil, nutritional treatment, functional food, hyperlipidemia, serum lipids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Kastamonu UniversityUniversity, hospital or other
- Collaborators
- Okan University
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 3 Nov 2023 (actual)
- First posted
- 14 Aug 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.
Aim of the Study:
This randomized controlled experimental study aimed to evaluate the effects of cholesterol-restricted diets enriched with pumpkin seeds and pumpkin seed oil on cardiovascular risk factors-specifically serum lipid profile (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides), blood pressure, and anthropometric measurements (body weight, body mass index, body fat percentage, and fat mass)-in individuals with hyperlipidemia.
Research Questions:
Does the nutritional intervention lead to a reduction in serum total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and triglyceride (TG) levels, as well as an increase in high-density lipoprotein cholesterol (HDL-C) levels across all study groups?
Do the groups receiving diets enriched with pumpkin seeds or pumpkin seed oil show greater improvements in lipid profile (TC, LDL-C, TG) and a more pronounced increase in HDL-C compared to the control group?
Does the nutritional intervention result in reductions in body weight, BMI, body fat percentage, and fat mass in all study groups?
Detailed description
The aim of this randomized controlled trial was to investigate the effects of cholesterol-restricted diets enriched with pumpkin seeds or pumpkin seed oil on cardiovascular risk factors in individuals with hyperlipidemia. Specifically, the study aimed to determine the effects of these dietary interventions on serum lipid parameters (total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides), blood pressure (systolic and diastolic), and anthropometric measurements (body weight, body mass index, body fat percentage, and fat mass) over a 28-day period.
The study hypothesizes that incorporating pumpkin seeds or pumpkin seed oil into a cholesterol-restricted diet will improve serum lipid parameters and blood pressure, and reduce anthropometric measurements.
Research Questions:
Primary Questions:
Does consumption of a cholesterol-restricted diet in individuals with hyperlipidemia result in statistically significant improvements in the serum lipid profile (i.e., decreases in TC, LDL-C, and TG, and increases in HDL-C)?
Do diets enriched with pumpkin seeds or pumpkin seed oil lead to greater improvements in these lipid parameters compared to a control group that only follows a cholesterol-restricted diet?
Secondary Questions:
Does the intervention (regardless of group) lead to reductions in anthropometric indices such as body weight, BMI, body fat percentage, and fat mass?
Are reductions in anthropometric measurements and improvements in blood pressure more pronounced in groups consuming diets enriched with pumpkin seeds or pumpkin seed oil compared to the control group?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pumpkin seed | Experimental | Dietary Supplement: low cholesterol diet30 g/day pumpkin seed and low cholesterol diet (28 days) |
| pumpkin seed oil | Experimental | Dietary Supplement: low cholesterol diet15 g/day pumpkin seed oil and low cholesterol diet (28 days) |
| control | Experimental | Dietary Supplement: low cholesterol dietlow cholesterol diet (28 days) |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Aged between 19 and 64 years
- Body mass index (BMI) between 25.0 and 30.0 kg/m²
- Triglyceride (TG) level > 200 mg/dL
- Low-density lipoprotein cholesterol (LDL-C) between 130 and 190 mg/dL
- Fasting blood glucose < 110 mg/dL
Key exclusion criteria (13 listed)
- Individuals will be excluded if they meet any of the following criteria:
- Diagnosis of any systemic disease, including:
- Diabetes mellitus
- Hypertension
- Cancer
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 |
|---|---|---|
| low cholesterol dietlow cholesterol diet | Dietary supplement | control, pumpkin seed, pumpkin seed oil |
Primary outcome
Change in Serum Total Cholesterol (mg/dL) from Baseline to Day 28
Time frame: Baseline and Day 28
Measured from 12-hour fasting venous blood samples using enzymatic colorimetric methods on an automated analyzer. Reference ranges per Turkish Society of Endocrinology and Metabolism (TEMD) Dyslipidemia Guidelines, 2021: desirable <200 mg/dL, borderline high 200-239 mg/dL, high ≥240 mg/dL.
Change in Serum LDL-Cholesterol (mg/dL) from Baseline to Day 28
Time frame: Baseline and Day 28
Calculated using the Friedewald formula from fasting lipid profile. Reference ranges per TEMD, 2021: optimal <100 mg/dL (or <70 mg/dL for very high cardiovascular risk), borderline high 130-159 mg/dL, high 160-189 mg/dL, very high ≥190 mg/dL.
Change in Serum HDL-Cholesterol (mg/dL) from Baseline to Day 28
Time frame: Baseline and Day 28
Measured from fasting venous blood using enzymatic methods. Reference ranges per TEMD, 2021: low HDL <40 mg/dL in men and <50 mg/dL in women; protective ≥60 mg/dL.
Change in Serum Triglycerides (mg/dL) from Baseline to Day 28
Time frame: Baseline and Day 28
Measured from fasting venous blood using enzymatic methods. Reference ranges per TEMD, 2021: normal <150 mg/dL, borderline high 150-199 mg/dL, high 200-499 mg/dL, very high ≥500 mg/dL.
9 secondary outcomes
Change in Body Weight (kg) from Baseline to Day 28
Time frame: Baseline and Day 28
Height (m) at Baseline
Time frame: Baseline
Change in Body Mass Index (kg/m²) from Baseline to Day 28
Time frame: Baseline and Day 28
Change in Body Fat Percentage (%) from Baseline to Day 28
Time frame: Baseline and Day 28
Change in Fat Mass (kg) from Baseline to Day 28
Time frame: Baseline and Day 28
Change in Systolic Blood Pressure (mmHg) from Baseline to Day 28
Time frame: Baseline and Day 28
Change in Diastolic Blood Pressure (mmHg) from Baseline to Day 28
Time frame: Baseline and Day 28
Change in Dietary Energy and Nutrient Intake (kcal/day, g/day, mg/day) from Baseline to Day 28
Time frame: Baseline and Day 28
Change in Food Group Consumption Frequency (times/week) from Baseline to Day 28
Time frame: Baseline and Day 28
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 14 Aug 2025.
- Derived from this study: PubMed 42955537Karli K, Yilmaz HO, Incaman D. Pumpkin seed and seed oil affect triglyceride levels in adults with hyperlipidemia: a randomized controlled trial. Ir J Med Sci. 2026 Oct 28. doi: 10.1007/s11845-026-04706-3. Online ahead of print.
- Individual participant dataSharing planned: Yes. The study protocol and informed consent form will be shared with other researchers upon request. However, no individual participant data (IPD) such as de-identified participant-level health data will be shared. The shared documents will not include any personal or outcome data of participants.
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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.
Hande Öngün Yılmaz, pHD study director
hyilmaz@bandirma.edu.tr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low cholesterol diet in people with Hyperlipidemia and Overweight, run by Kastamonu University at 1 site in Turkey (Türkiye).
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 7 inclusion and 13 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 14 Aug 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 Turkey (Türkiye). 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 Serum Total Cholesterol (mg/dL) from Baseline to Day 28 (time frame: Baseline and Day 28). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07123844, which also lists 1 linked publication.
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 14 Aug 2025.