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临床试验/NCT07696559
NCT07696559已完成不适用

Effects of β-sitosterol -Enriched Dietary Intervention on Lipid Profile to Alleviate Hyperlipidemia Among Grade II Obese Individuals

University of Lahore1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Body Mass Index

研究概览

简要总结

The purpose of the study is to assess the effect of β -Sitosterol enriched dietary intervention on lipid profile to alleviate hyperlipidemia among Grade II obese patients

详细描述

The study was conducted at University of Lahore Teaching Hospital, Lahore to assess the outcomes two dietary intervention. One contains regular food diet plan for hyperlipidemic patients. While, the other plan contains all the specified food product that contains B-sitosterol compound. Then, B-sitosterol food enriched diet plan contains specified amount of this phytosterol (1.5-3g).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
25 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 25-55 years
  • Diagnosed with hyperlipidemia (LDL ≥ 130 mg/dL or Total Cholesterol ≥ 200 mg/dL)
  • BMI between 35.0-39.9 kg/m²
  • Willing to follow a prescribed diet plan for the entire study duration

排除标准

  • Patients with sitosterolemia, kidney or liver diseases
  • Pregnant or lactating women
  • Current use of statins, fibrates, or plant sterol supplements
  • Individuals with food allergies to any prescribed ingredients

结局指标

主要结局

Body Mass Index

时间窗: 8 weeks

BMI is defined as body weight in kilograms divided by height in meters squared (kg/m²). BMI cut-off points are used to assess weight status, categorizing individuals as underweight, normal, overweight or obese. Obesity is further classified into grades 1, 2 and 3.

Lipid Profile

时间窗: 8 weeks

Blood lipid profile will be obtained using fasting blood samples to determine serum total cholesterol, high-density lipoprotein cholesterol (HD L-C), low density lipoprotein cholesterol (LDL-C) and triglycerides.

次要结局

未报告次要终点

研究者

发起方
University of Lahore
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Aslam

Clinical Head University Institute of Diet and Nutritional Sciences

University of Lahore

研究点 (1)

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