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临床试验/NCT07144488
NCT07144488已完成不适用

The Impact of Olive Oil Polyphenol Supplementation on Metabolic Syndrome Parameters

Apostolos Loukas Medical Centre Cyprus1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2024年9月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
106
试验地点
1
主要终点
Glycated haemoglobin

研究概览

简要总结

Olive oil polyphenols, particularly oleocanthal, oleacein, and related secoiridoids, have shown anti-inflammatory and antioxidant properties in preclinical studies. Metabolic syndrome (MetS) is characterized by a constellation of risk factors, including central obesity, dyslipidemia, hypertension, and dysglycemia, which collectively contribute to a substantially elevated risk of cardiovascular disease (CVD) and type 2 diabetes mellitus (T2DM). Preclinical investigations have demonstrated that olive oil polyphenols, notably oleocanthal, oleacein, and allied secoiridoids, possess anti-inflammatory and antioxidant attributes.

The goal of this clinical trial is to learn if a polyphenol-rich olive oil extract works to improve metabolic syndrome (MetS) parameters in adults. It will also evaluate the safety of the supplement. The main questions it aims to answer are:

Does the olive oil extract improve fasting blood glucose and HbA1c levels?

How does the supplement affect other health measures such as cholesterol levels, inflammation (CRP), body mass index (BMI), blood pressure, waist size, liver function (ALT), kidney function (eGFR), uric acid levels, and fatigue?

Researchers will compare the olive oil extract supplement to a placebo (a look-alike substance with no active ingredients) to see if the supplement can help manage metabolic syndrome.

Participants will:

Take either 10 mg of the olive oil extract supplement or a placebo once daily for 12 weeks

Attend clinic visits for tests and checkups at the beginning and end of the study period

Have their blood sugar, cholesterol, inflammation markers, liver and kidney function, and other health parameters measured before and after the treatment

Complete questionnaires assessing fatigue levels

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Both participants and study staff were blinded to group allocation. Placebo and active capsules were identical in appearance, weight, and taste

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 30-70 years with a diagnosis of MetS per International Diabetes Federation criteria were enrolled after informed consent.

排除标准

  • 未提供

结局指标

主要结局

Glycated haemoglobin

时间窗: 12 weeks

Change in HbA1c levels

Fasting blood glucose

时间窗: 12 weeks

Change in fasting blood glucose levels

次要结局

  • Lipid profile(12 weeks)
  • Fatigue / Energy levels(12 weeks)

研究者

发起方
Apostolos Loukas Medical Centre Cyprus
申办方类型
Network
责任方
Sponsor

研究点 (1)

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