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

Kastamonu University

Status: Completed

Conditions: Overweight; Hyperlipidemia

Treatments: Dietary Supplement: low cholesterol diet

Study type: Interventional

Funder types: Other

Identifiers

NCT07123844

2022--KAEK-37

Details and patient eligibility

About

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?

Full 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?

Enrollment: 159 patients

Sex: All

Ages: 19 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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159 participants in 3 patient groups

pumpkin seed

Experimental group

Description:

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

Treatment:

Dietary Supplement: low cholesterol diet

pumpkin seed oil

Experimental group

Description:

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

Treatment:

Dietary Supplement: low cholesterol diet

control

Experimental group

Description:

low cholesterol diet (28 days)

Treatment:

Dietary Supplement: low cholesterol diet