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

NCT04081818 | Completed

• 1 other identifier: Nutritious_Mushrooms_61100
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

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

  3 months

Secondary Outcomes (5)

• 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

Study Arms (2)

Intervention group (Nutritious Mushrooms)

ACTIVE COMPARATOR

Other: Nutritious Mushrooms

Control group

NO INTERVENTION

Interventions

Nutritious Mushrooms OTHER

The Intervention group will consume antioxidant rich and Vitamin D2-enhanced mushrooms as a snack daily for 3 months.

Intervention group (Nutritious Mushrooms)

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harokopio University: lead

Study Sites (1)

Andriana Kaliora

Athens, 17671, Greece

Location

Related Publications (10)

• 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.

  PMID: 25548896 BACKGROUND

• 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.

  PMID: 30322118 BACKGROUND

• 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.

  PMID: 25791371 BACKGROUND

• 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.

  PMID: 25908506 BACKGROUND

• Norman PE, Powell JT. Vitamin D and cardiovascular disease. Circ Res. 2014 Jan 17;114(2):379-93. doi: 10.1161/CIRCRESAHA.113.301241.

  PMID: 24436433 BACKGROUND

• 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.

  PMID: 18400738 BACKGROUND

• 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.

  PMID: 25009502 BACKGROUND

• 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.

  PMID: 21540874 BACKGROUND

• 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.

  PMID: 22187640 BACKGROUND

• Ganesan K, Xu B. Anti-Obesity Effects of Medicinal and Edible Mushrooms. Molecules. 2018 Nov 5;23(11):2880. doi: 10.3390/molecules23112880.

  PMID: 30400600 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Foods and Human Nutrition

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: September 9, 2019
• Study Start: January 1, 2021
• Primary Completion: March 16, 2022
• Study Completion: March 16, 2022
• Last Updated: October 3, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)