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

NCT07123844 | Completed

• 1 other identifier: 2022--KAEK-37
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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?

Conditions

Hyperlipidemia; Overweight

Keywords

overweight; pumpkin seed; pumpkin seed oil; nutritional treatment; functional food; hyperlipidemia; serum lipids

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline and Day 28

Secondary Outcomes (9)

• Change in Body Weight (kg) from Baseline to Day 28

  Baseline and Day 28

• Height (m) at Baseline

  Baseline

• Change in Body Mass Index (kg/m²) from Baseline to Day 28

  Baseline and Day 28

• Change in Body Fat Percentage (%) from Baseline to Day 28

  Baseline and Day 28

• Change in Fat Mass (kg) from Baseline to Day 28

  Baseline and Day 28

Study Arms (3)

pumpkin seed

EXPERIMENTAL

30 g/day pumpkin seed and low cholesterol diet (28 days)

Dietary Supplement: low cholesterol diet

pumpkin seed oil

EXPERIMENTAL

15 g/day pumpkin seed oil and low cholesterol diet (28 days)

Dietary Supplement: low cholesterol diet

control

EXPERIMENTAL

low cholesterol diet (28 days)

Dietary Supplement: low cholesterol diet

Interventions

low cholesterol diet DIETARY_SUPPLEMENT

low cholesterol diet

control; pumpkin seed; pumpkin seed oil

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Individuals will be excluded if they meet any of the following criteria:
• Diagnosis of any systemic disease, including:
• Diabetes mellitus
• Hypertension
• Cancer
• Metabolic syndrome
• 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

Sponsors & Collaborators

• Kastamonu University: lead
• Okan University: collaborator

Study Sites (1)

Kastamonu Training and Research Hospital

Kastamonu, 37100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hyperlipidemias; Overweight

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hande Öngün Yılmaz, pHD

  hyilmaz@bandirma.edu.tr

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 14, 2025
• Study Start: June 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: November 3, 2023
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 6 months after the publication of the main study results.
• Access Criteria: Interested researchers may request access by contacting the investigator via email at kevserkarli@gmail.com or kevserkarli@kastamonu.edu.tr. Data will be shared via secure email format.

Locations

TU (1)