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临床试验/NCT04081818
NCT04081818已完成不适用

A Study on the Effects of Nutritious Mushrooms in Adults With Metabolic Syndrome

Harokopio University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Insulin sensitivity change pre- and post- intervention in each arm, measuring fasting blood sugar levels.

研究概览

简要总结

Obesity, characterized by an increase in body weight that results in excessive fat accumulation, is a global health problem. Recently, it has also been shown that obesity is associated with low-grade chronic systemic inflammation in adipose tissue. This condition is mediated by activation of the innate immune system in adipose tissue that promotes inflammation and oxidative stress and triggers a systemic acute-phase response.

Previous research points towards the potential of phytochemicals in food as part of nutritional strategies for the prevention of obesity and associated inflammation, as well as, increase in insulin sensitivity in diabetic patients.

In addition, there is strong evidence that obesity is inversely associated with vitamin D levels. The major cause of vitamin D deficiency in humans is the lack of adequate sun exposure. Unfortunately, very few foods, i.e. mushrooms, naturally contain vitamin D and foods that are fortified with vitamin D are inadequate to satisfy vitamin D requirements.

The last decade, mushrooms have attracted the research interest as functional foods with desirable health benefits in several metabolic disorders without the side effects of pharmacological treatment. Edible mushrooms are highly nutritious and exhibit beneficial effects on several inflammatory diseases such as cancer, heart disease, diabetes,, high blood pressure.

Thus, the purpose of this study is to determine the effects of nutritious mushrooms in adults with Metabolic Syndrome. More specifically, 100 participants will be allocated to two groups, namely intervention group (N=50) and control group (N=50). Vitamin D2-enhanced mushrooms by UV-B will be provided as a snack to the intervention group, whereas the control group will not consume the snack. The intervention will last 3 months.The effects of the intervention will be evaluated via clinical and laboratory markers. Personal and family history, anthropometric, demographic data, body composition, dietary habits, physical activity and smoking status will be assessed pre- and post- intervention. Biochemical profile, oxidative stress and inflammation, as well as metabolomic profiles will be assessed in blood samples pre- and post- intervention. Both groups will receive standard nutritional counselling throughout the intervention and will be encouraged to report any adverse effects they may experience during the intervention.

研究设计

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

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 30 years < Age < 65 years
  • BMI > 25 kg/ m2
  • Metabolic Syndrome

排除标准

  • Hepatotoxic Medication
  • Diabetes Mellitus
  • Dysthyroidism, hypopituitarism, Cushing syndrome / disease
  • Pregnancy, lactation
  • Psychiatric or mental disorder
  • Any use of antioxidant-phytochemical rich supplement, vitamin D supplement, nti-, pre- or pro-biotics within 3 months pre-intervention

结局指标

主要结局

Insulin sensitivity change pre- and post- intervention in each arm, measuring fasting blood sugar levels.

时间窗: 3 months

次要结局

  • Quality of life change pre- and post- intervention in each arm(3 months)
  • Anthropometric measures change pre- and post- intervention in each arm(3 months)
  • Inflammation and oxidative stress markers change pre- and post- intervention in each arm(3 months)
  • Vitamin D2 levels change pre- and post- intervention in each arm(3 months)
  • Biochemical markers change pre- and post- intervention in each arm(3 months)

研究者

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

Andriana C Kaliora

Assistant Professor in Foods and Human Nutrition

Harokopio University

研究点 (2)

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