Clinical trial NCT04444219: Postprandial Glucose, Insulin Responses and Appetite Hormones to Dried Mushrooms
Official title: Postprandial Glucose, Insulin Responses and Appetite Hormones to Dried Mushrooms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Harokopio University
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.

The last decade, mushrooms have attracted the research interest as functional foods rich in beta-glucan 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.

However, the postprandial effect of mushrooms in human biological samples is still undetermined. To this end, the current study aims to investigate if there is any effect at postprandial glucose, insulin responses and appetite hormones. Fifteen apparently men and women with Metabolic Syndrome, aged 18-65 years old, will be enrolled based on certain inclusion and exclusion criteria.

After enrollment, the volunteers will undergo a medical and dietary assessment and their health status will be evaluated through a complete blood count. On the day of the experiment and after overnight fasting, the volunteers will consume one of two breakfast meal, including 114g bread, 40g cheese and 15g dry mushrooms (meal 1) or 114g bread, 40g cheese and 200g tomatoes (meal 2). Blood samples will be obtained on timepoints 0h, 30min, 1h, 1,5h, 2h, 2,5h and 3h after breakfast intake. Two weeks later, the same volunteers will consume the other breakfast meal.

After collection, the glucose and insulin values will be identified in plasma samples. Additionally, some appetite hormones will be measureD in serum samples.


Eligibility criteria: Inclusion Criteria:

18 years \< Age \< 75 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: Difference of Glucose levels
timeFrame: 1 month
measure: Difference of Insulin levels
timeFrame: 1 month
measure: Difference of appetite hormones levels
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Andriana Kaliora
Study officials:
References:
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.
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.
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.
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.
citation: Ganesan K, Xu B. Anti-Obesity Effects of Medicinal and Edible Mushrooms. Molecules. 2018 Nov 5;23(11):2880. doi: 10.3390/molecules23112880.