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临床试验/NCT07231367
NCT07231367已完成不适用

"Cholesterol-lowering Potential of Sunflower Seeds: Evidence From Phytochemical and Fatty Acid Composition and a Randomized Human Trial"

University of Faisalabad1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2023年7月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
1
主要终点
Change in Total Cholesterol

研究概览

简要总结

This study evaluates the effect of daily consumption of sunflower seeds on blood cholesterol levels in adult participants. Participants were randomly assigned to consume a specified amount of sunflower seeds for a defined period, and their blood cholesterol and lipid profile were measured before and after the intervention. The study aims to determine whether sunflower seeds can contribute to improving cardiovascular health by lowering cholesterol. Adult men and women meeting the eligibility criteria were included in the study. The findings may help inform dietary recommendations for managing cholesterol and promoting heart health.

详细描述

This randomized, open-label human trial evaluated the cholesterol-lowering potential of sunflower seeds in adult participants. Eligible men and women were recruited based on inclusion criteria, which included age range, baseline cholesterol levels, and absence of major health conditions. Participants were randomly assigned to consume a defined daily portion of sunflower seeds for a specified intervention period. Blood samples were collected at baseline and at the end of the intervention to measure total cholesterol, LDL-C, HDL-C, triglycerides, and other relevant lipid parameters.

Prior to the human intervention, sunflower seeds were analyzed for their nutritional composition, mineral content, phytochemical profile, and fatty acid composition using standard laboratory procedures. Tests included proximate analysis (moisture, protein, fat, ash, and carbohydrate content), mineral quantification (calcium, magnesium, potassium, etc.), phytochemical assays (total phenolics, flavonoids), and fatty acid profiling using gas chromatography. These analyses provided a detailed characterization of the seeds' bioactive components relevant to cardiovascular health.

The study also included assessments of dietary intake, anthropometric measurements, and adherence to the intervention. The primary objective was to determine the effect of sunflower seed consumption on blood cholesterol levels, while secondary objectives included evaluating changes in lipid profile and potential associations with bioactive components of the seeds. Data were analyzed using standard statistical methods. The results aim to provide evidence on the role of sunflower seeds in cardiovascular risk management and to inform dietary recommendations.

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
40 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Participants included males aged between 40 and 50 years, with serum cholesterol levels exceeding 200 mg/dL, and shared the same socioeconomic status.

排除标准

  • •The participants were excluded based on different physiological factors, such as active smokers, alcoholics, chronic disease patients, people having extremely low or high BMI, people suffering from psychological disorders or familial hypercholesterolemia, people who belong to a high-income group, and people having doubts or confusion while following instructions

研究组 & 干预措施

Control

No Intervention

Participants continued their usual diet without consuming sunflower seeds. Blood cholesterol and lipid profiles were measured at baseline and at the end of the study period.

Diseased Group

Experimental

Participants consumed a defined daily portion of sunflower seeds for the duration of the study. Blood samples were collected at baseline and after the intervention to measure total cholesterol, LDL-C, HDL-C, triglycerides, and other lipid parameters. Dietary intake and adherence to the intervention were monitored throughout the study period

干预措施: Sunflower Seed Supplementation (Dietary Supplement)

结局指标

主要结局

Change in Total Cholesterol

时间窗: Baseline and 45 days after intervention

Total serum cholesterol measured using standard enzymatic methods at baseline and at the end of the 45 days sunflower seed supplementation period.

次要结局

  • LDL Cholesterol(Baseline and 45 days after intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amna Butt

Lecturer

University of Faisalabad

研究点 (1)

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