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

Study Overview
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Brief Summary
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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.

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

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Other: Nutritious Mushrooms


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 30 years < Age < 65 years BMI > 25 kg/ m2 Metabolic Syndrome Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group (Nutritious Mushrooms)<br> | Other: Nutritious Mushrooms<br>* The Intervention group will consume antioxidant rich and Vitamin D2-enhanced mushrooms as a snack daily for 3 months.<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity change pre- and post- intervention in each arm, measuring fasting blood sugar levels. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D2 levels change pre- and post- intervention in each arm |  | 3 months | 
| Anthropometric measures change pre- and post- intervention in each arm |  | 3 months | 
| Biochemical markers 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 | 
| Quality of life change pre- and post- intervention in each arm |  | 3 months |