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

Sponsor
Harokopio University (Other)
Overall Status
Completed
CT.gov ID
NCT04081818
Collaborator
(none)
100
1
2
14.4
6.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Nutritious Mushrooms
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Study on the Effects of Nutritious Mushrooms in Adults With Metabolic Syndrome
Actual Study Start Date :
Jan 1, 2021
Actual Primary Completion Date :
Mar 16, 2022
Actual Study Completion Date :
Mar 16, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Intervention group (Nutritious Mushrooms)

Other: Nutritious Mushrooms
The Intervention group will consume antioxidant rich and Vitamin D2-enhanced mushrooms as a snack daily for 2 months.

No Intervention: Control group

Outcome Measures

Primary Outcome Measures

  1. Insulin sensitivity change pre- and post- intervention in each arm, measuring fasting blood sugar levels. [2 months]

  2. Insulin sensitivity change pre- and post- intervention in each arm, measuring Hemoglobin A1c [2 months]

  3. Vitamin D levels change pre- and post- intervention in each arm [2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Andriana Kaliora Athens Greece 17671

Sponsors and Collaborators

  • Harokopio University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Andriana C Kaliora, Assistant Professor in Foods and Human Nutrition, Harokopio University
ClinicalTrials.gov Identifier:
NCT04081818
Other Study ID Numbers:
  • Nutritious_Mushrooms_61100
First Posted:
Sep 9, 2019
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022