Clinical trial NCT04081818: A Study on the Effects of Nutritious Mushrooms in Adults With Metabolic Syndrome
Official title: A Study on the Effects of Nutritious Mushrooms in Adults With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Harokopio University
Sponsor class: OTHER
First posted: 2019-09-09
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Insulin sensitivity change pre- and post- intervention in each arm, measuring fasting blood sugar levels.
timeFrame: 3 months
Secondary outcomes:
measure: Vitamin D2 levels change pre- and post- intervention in each arm
timeFrame: 3 months
measure: Anthropometric measures change pre- and post- intervention in each arm
timeFrame: 3 months
measure: Biochemical markers change pre- and post- intervention in each arm
timeFrame: 3 months
measure: Inflammation and oxidative stress markers change pre- and post- intervention in each arm
timeFrame: 3 months
measure: Quality of life change pre- and post- intervention in each arm
timeFrame: 3 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Andriana Kaliora
Study officials:
References:
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