- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04444219
Postprandial Glucose, Insulin Responses and Appetite Hormones to Dried Mushrooms
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Athens, Greece, 17671
- Andriana Kaliora
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Breakfast meal_1
100 g white bread, 40 g yellow cheese and Κing Oyster mushrooms (test meal)
|
Fifteen volunteers will undergo a medical and dietary assessment and their health status will be evaluated through a complete blood count.
Then, they will come after overnight fasting and will consume one of two breakfast meals, 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.
|
Other: Breakfast meal_2
100 g white bread, 40 g yellow cheese and 6-7 cherry tomatoes (control meal)
|
Fifteen volunteers will undergo a medical and dietary assessment and their health status will be evaluated through a complete blood count.
Then, they will come after overnight fasting and will consume one of two breakfast meals, 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference of Glucose levels
Time Frame: 1 month
|
Difference of Glucose levels after consuming the two meals
|
1 month
|
Difference of Insulin levels
Time Frame: 1 month
|
Difference of insulin levels after consuming the two meals
|
1 month
|
Difference of appetite hormones levels
Time Frame: 1 month
|
Difference of appetite hormones levels after consuming the two meals
|
1 month
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- Ganesan K, Xu B. Anti-Obesity Effects of Medicinal and Edible Mushrooms. Molecules. 2018 Nov 5;23(11):2880. doi: 10.3390/molecules23112880.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Nutritious_Mushrooms_Postprand
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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