Postprandial Glucose, Insulin Responses and Appetite Hormones to Dried Mushrooms
Primary Purpose
Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Breakfast meals
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Syndrome
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
Sites / Locations
- Andriana Kaliora
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Breakfast meal_1
Breakfast meal_2
Arm Description
100 g white bread, 40 g yellow cheese and Κing Oyster mushrooms (test meal)
100 g white bread, 40 g yellow cheese and 6-7 cherry tomatoes (control meal)
Outcomes
Primary Outcome Measures
Difference of Glucose levels
Difference of Glucose levels after consuming the two meals
Difference of Insulin levels
Difference of insulin levels after consuming the two meals
Difference of appetite hormones levels
Difference of appetite hormones levels after consuming the two meals
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04444219
Brief Title
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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
July 31, 2021 (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
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.
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.
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
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Breakfast meal_1
Arm Type
Other
Arm Description
100 g white bread, 40 g yellow cheese and Κing Oyster mushrooms (test meal)
Arm Title
Breakfast meal_2
Arm Type
Other
Arm Description
100 g white bread, 40 g yellow cheese and 6-7 cherry tomatoes (control meal)
Intervention Type
Other
Intervention Name(s)
Breakfast meals
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference of Glucose levels
Description
Difference of Glucose levels after consuming the two meals
Time Frame
1 month
Title
Difference of Insulin levels
Description
Difference of insulin levels after consuming the two meals
Time Frame
1 month
Title
Difference of appetite hormones levels
Description
Difference of appetite hormones levels after consuming the two meals
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Andriana Kaliora
City
Athens
ZIP/Postal Code
17671
Country
Greece
12. IPD Sharing Statement
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
background
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
background
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
background
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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Postprandial Glucose, Insulin Responses and Appetite Hormones to Dried Mushrooms
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