The Effects of Cholesterol-Restricted Diets Enriched With Pumpkin Seeds and Pumpkin Seed Oil on Cardiovascular Risk Factors in Individuals With Hyperlipidaemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Change in Serum Total Cholesterol (mg/dL) from Baseline to Day 28
研究概览
简要总结
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?
详细描述
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)?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Individuals will be excluded if they meet any of the following criteria:
- •Diagnosis of any systemic disease, including:
- •Diabetes mellitus
- •Hypertension
- •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
研究组 & 干预措施
pumpkin seed
30 g/day pumpkin seed and low cholesterol diet (28 days)
干预措施: low cholesterol diet (Dietary Supplement)
pumpkin seed oil
15 g/day pumpkin seed oil and low cholesterol diet (28 days)
干预措施: low cholesterol diet (Dietary Supplement)
control
low cholesterol diet (28 days)
干预措施: low cholesterol diet (Dietary Supplement)
结局指标
主要结局
Change in Serum Total Cholesterol (mg/dL) from Baseline to Day 28
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
- Change in Food Group Consumption Frequency (times/week) from Baseline to Day 28(Baseline and Day 28)
- Change in Body Weight (kg) from Baseline to Day 28(Baseline and Day 28)
- Change in Systolic Blood Pressure (mmHg) from Baseline to Day 28(Baseline and Day 28)
- Change in Diastolic Blood Pressure (mmHg) from Baseline to Day 28(Baseline and Day 28)
- Change in Dietary Energy and Nutrient Intake (kcal/day, g/day, mg/day) from Baseline to Day 28(Baseline and Day 28)
研究者
Kevser Karli
Principal Investigator
Kastamonu University