Pumpkin Seeds or Oil Lower Serum Triglyceride Levels in Individuals With Hyperlipidaemia

Not Applicable

Completed

• Conditions: Hyperlipidemia; Overweight

• Registration Number: NCT07123844
• Lead Sponsor: Kastamonu University

Brief 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 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 Timeline

• Study Start: 2022-06-01
• Primary Completion: 2023-09-30
• Study Completion: 2023-11-03
• Study First Submitted: 2025-07-30
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-08
• Last Update Submitted: 2025-08-08
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Serum Total Cholesterol (mg/dL) from Baseline to Day 28	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	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Height (m) at Baseline	Baseline	Measured using a Densi GL 150 stadiometer.
Change in Body Mass Index (kg/m²) from Baseline to Day 28	Baseline and 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.
Change in Body Fat Percentage (%) from Baseline to Day 28	Baseline and Day 28	Measured using a Tanita TBF-300 BIA.
Change in Fat Mass (kg) from Baseline to Day 28	Baseline and Day 28	Measured using a Tanita TBF-300 BIA.
Change in Food Group Consumption Frequency (times/week) from Baseline to Day 28	Baseline and Day 28	Evaluated using a structured dietary habits questionnaire. Frequency data categorized by major food groups and analyzed for change over time.
Change in Body Weight (kg) from Baseline to Day 28	Baseline and Day 28	Measured without shoes and in light clothing using a Tanita TBF-300 bioelectrical impedance analyzer (BIA).
Change in Systolic Blood Pressure (mmHg) from Baseline to Day 28	Baseline and 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.
Change in Diastolic Blood Pressure (mmHg) from Baseline to Day 28	Baseline and Day 28	Same procedure as systolic BP measurement. Reference ranges per ESC/ESH Guidelines, 2018: normal \<80 mmHg; elevated 80-89 mmHg.
Change in Dietary Energy and Nutrient Intake (kcal/day, g/day, mg/day) from Baseline to Day 28	Baseline and 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).

Trial Locations

Locations (1)

Kastamonu Training and Research Hospital; 🇹🇷 Kastamonu, Turkey