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

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Nutritious Mushrooms
Sponsored by
Harokopio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Andriana Kaliora

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention group (Nutritious Mushrooms)

Control group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 20, 2019
Last Updated
September 28, 2022
Sponsor
Harokopio University
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1. Study Identification

Unique Protocol Identification Number
NCT04081818
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
March 16, 2022 (Actual)
Study Completion Date
March 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harokopio University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group (Nutritious Mushrooms)
Arm Type
Active Comparator
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Nutritious Mushrooms
Intervention Description
The Intervention group will consume antioxidant rich and Vitamin D2-enhanced mushrooms as a snack daily for 3 months.
Primary Outcome Measure Information:
Title
Insulin sensitivity change pre- and post- intervention in each arm, measuring fasting blood sugar levels.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Vitamin D2 levels change pre- and post- intervention in each arm
Time Frame
3 months
Title
Anthropometric measures change pre- and post- intervention in each arm
Time Frame
3 months
Title
Biochemical markers change pre- and post- intervention in each arm
Time Frame
3 months
Title
Inflammation and oxidative stress markers change pre- and post- intervention in each arm
Time Frame
3 months
Title
Quality of life change pre- and post- intervention in each arm
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Andriana Kaliora
City
Athens
ZIP/Postal Code
17671
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25548896
Citation
Marseglia L, Manti S, D'Angelo G, Nicotera A, Parisi E, Di Rosa G, Gitto E, Arrigo T. Oxidative stress in obesity: a critical component in human diseases. Int J Mol Sci. 2014 Dec 26;16(1):378-400. doi: 10.3390/ijms16010378.
Results Reference
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PubMed Identifier
30322118
Citation
Cardwell G, Bornman JF, James AP, Black LJ. A Review of Mushrooms as a Potential Source of Dietary Vitamin D. Nutrients. 2018 Oct 13;10(10):1498. doi: 10.3390/nu10101498.
Results Reference
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PubMed Identifier
25791371
Citation
Abdali D, Samson SE, Grover AK. How effective are antioxidant supplements in obesity and diabetes? Med Princ Pract. 2015;24(3):201-15. doi: 10.1159/000375305. Epub 2015 Mar 14.
Results Reference
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PubMed Identifier
25908506
Citation
Duggan C, de Dieu Tapsoba J, Mason C, Imayama I, Korde L, Wang CY, McTiernan A. Effect of Vitamin D3 Supplementation in Combination with Weight Loss on Inflammatory Biomarkers in Postmenopausal Women: A Randomized Controlled Trial. Cancer Prev Res (Phila). 2015 Jul;8(7):628-35. doi: 10.1158/1940-6207.CAPR-14-0449. Epub 2015 Apr 23.
Results Reference
background
PubMed Identifier
24436433
Citation
Norman PE, Powell JT. Vitamin D and cardiovascular disease. Circ Res. 2014 Jan 17;114(2):379-93. doi: 10.1161/CIRCRESAHA.113.301241.
Results Reference
background
PubMed Identifier
18400738
Citation
Holick MF, Chen TC. Vitamin D deficiency: a worldwide problem with health consequences. Am J Clin Nutr. 2008 Apr;87(4):1080S-6S. doi: 10.1093/ajcn/87.4.1080S.
Results Reference
background
PubMed Identifier
25009502
Citation
Mutt SJ, Hypponen E, Saarnio J, Jarvelin MR, Herzig KH. Vitamin D and adipose tissue-more than storage. Front Physiol. 2014 Jun 24;5:228. doi: 10.3389/fphys.2014.00228. eCollection 2014.
Results Reference
background
PubMed Identifier
21540874
Citation
Urbain P, Singler F, Ihorst G, Biesalski HK, Bertz H. Bioavailability of vitamin D(2) from UV-B-irradiated button mushrooms in healthy adults deficient in serum 25-hydroxyvitamin D: a randomized controlled trial. Eur J Clin Nutr. 2011 Aug;65(8):965-71. doi: 10.1038/ejcn.2011.53. Epub 2011 May 4.
Results Reference
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PubMed Identifier
22187640
Citation
El Khoury D, Cuda C, Luhovyy BL, Anderson GH. Beta glucan: health benefits in obesity and metabolic syndrome. J Nutr Metab. 2012;2012:851362. doi: 10.1155/2012/851362. Epub 2011 Dec 11.
Results Reference
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PubMed Identifier
30400600
Citation
Ganesan K, Xu B. Anti-Obesity Effects of Medicinal and Edible Mushrooms. Molecules. 2018 Nov 5;23(11):2880. doi: 10.3390/molecules23112880.
Results Reference
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A Study on the Effects of Nutritious Mushrooms in Adults With Metabolic Syndrome

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