<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04444219</url>
  </required_header>
  <id_info>
    <org_study_id>Nutritious_Mushrooms_Postprand</org_study_id>
    <nct_id>NCT04444219</nct_id>
  </id_info>
  <brief_title>Postprandial Glucose, Insulin Responses and Appetite Hormones to Dried Mushrooms</brief_title>
  <official_title>Postprandial Glucose, Insulin Responses and Appetite Hormones to Dried Mushrooms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Harokopio University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Harokopio University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obesity, characterized by an increase in body weight that results in excessive fat&#xD;
      accumulation, is a global health problem. Recently, it has also been shown that obesity is&#xD;
      associated with low-grade chronic systemic inflammation in adipose tissue. This condition is&#xD;
      mediated by activation of the innate immune system in adipose tissue that promotes&#xD;
      inflammation and oxidative stress and triggers a systemic acute-phase response.&#xD;
&#xD;
      Previous research points towards the potential of phytochemicals in food as part of&#xD;
      nutritional strategies for the prevention of obesity and associated inflammation, as well as,&#xD;
      increase in insulin sensitivity in diabetic patients.&#xD;
&#xD;
      The last decade, mushrooms have attracted the research interest as functional foods rich in&#xD;
      beta-glucan with desirable health benefits in several metabolic disorders without the side&#xD;
      effects of pharmacological treatment. Edible mushrooms are highly nutritious and exhibit&#xD;
      beneficial effects on several inflammatory diseases such as cancer, heart disease, diabetes,,&#xD;
      high blood pressure.&#xD;
&#xD;
      However, the postprandial effect of mushrooms in human biological samples is still&#xD;
      undetermined. To this end, the current study aims to investigate if there is any effect at&#xD;
      postprandial glucose, insulin responses and appetite hormones. Fifteen apparently men and&#xD;
      women with Metabolic Syndrome, aged 18-65 years old, will be enrolled based on certain&#xD;
      inclusion and exclusion criteria.&#xD;
&#xD;
      After enrollment, the volunteers will undergo a medical and dietary assessment and their&#xD;
      health status will be evaluated through a complete blood count. On the day of the experiment&#xD;
      and after overnight fasting, the volunteers will consume one of two breakfast meal, including&#xD;
      114g bread, 40g cheese and 15g dry mushrooms (meal 1) or 114g bread, 40g cheese and 200g&#xD;
      tomatoes (meal 2). Blood samples will be obtained on timepoints 0h, 30min, 1h, 1,5h, 2h, 2,5h&#xD;
      and 3h after breakfast intake. Two weeks later, the same volunteers will consume the other&#xD;
      breakfast meal.&#xD;
&#xD;
      After collection, the glucose and insulin values will be identified in plasma samples.&#xD;
      Additionally, some appetite hormones will be measureD in serum samples.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">July 31, 2021</completion_date>
  <primary_completion_date type="Actual">March 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference of Glucose levels</measure>
    <time_frame>1 month</time_frame>
    <description>Difference of Glucose levels after consuming the two meals</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference of Insulin levels</measure>
    <time_frame>1 month</time_frame>
    <description>Difference of insulin levels after consuming the two meals</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference of appetite hormones levels</measure>
    <time_frame>1 month</time_frame>
    <description>Difference of appetite hormones levels after consuming the two meals</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>Breakfast meal_1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>100 g white bread, 40 g yellow cheese and Κing Oyster mushrooms (test meal)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Breakfast meal_2</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>100 g white bread, 40 g yellow cheese and 6-7 cherry tomatoes (control meal)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Breakfast meals</intervention_name>
    <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.</description>
    <arm_group_label>Breakfast meal_1</arm_group_label>
    <arm_group_label>Breakfast meal_2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        18 years &lt; Age &lt; 75 years BMI &gt; 25 kg/ m2 Metabolic Syndrome&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Hepatotoxic Medication Diabetes Mellitus Dysthyroidism, hypopituitarism, Cushing syndrome /&#xD;
        disease Pregnancy, lactation Psychiatric or mental disorder Any use of&#xD;
        antioxidant-phytochemical rich supplement, vitamin D supplement, nti-, pre- or pro-biotics&#xD;
        within 3 months pre-intervention&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>54 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Andriana Kaliora</name>
      <address>
        <city>Athens</city>
        <zip>17671</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <reference>
    <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>
    <PMID>25548896</PMID>
  </reference>
  <reference>
    <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>
    <PMID>30322118</PMID>
  </reference>
  <reference>
    <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>
    <PMID>25791371</PMID>
  </reference>
  <reference>
    <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>
    <PMID>22187640</PMID>
  </reference>
  <reference>
    <citation>Ganesan K, Xu B. Anti-Obesity Effects of Medicinal and Edible Mushrooms. Molecules. 2018 Nov 5;23(11):2880. doi: 10.3390/molecules23112880.</citation>
    <PMID>30400600</PMID>
  </reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>September 20, 2021</last_update_submitted>
  <last_update_submitted_qc>September 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Harokopio University</investigator_affiliation>
    <investigator_full_name>Andriana C Kaliora</investigator_full_name>
    <investigator_title>Assosiate Professor in Foods and Human Nutrition</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04444219
org study id: Nutritious_Mushrooms_Postprand
nct id: NCT04444219
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Difference of Glucose levels
time frame: 1 month
description: Difference of Glucose levels after consuming the two meals
measure: Difference of Insulin levels
time frame: 1 month
description: Difference of insulin levels after consuming the two meals
measure: Difference of appetite hormones levels
time frame: 1 month
description: Difference of appetite hormones levels after consuming the two meals
arm group label: Breakfast meal_1
arm group type: Other
description: 100 g white bread, 40 g yellow cheese and Κing Oyster mushrooms (test meal)
arm group label: Breakfast meal_2
arm group type: Other
description: 100 g white bread, 40 g yellow cheese and 6-7 cherry tomatoes (control meal)
intervention type: Other
intervention name: Breakfast meals
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.
arm group label: Breakfast meal_1
arm group label: Breakfast meal_2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 54 Years
healthy volunteers: No
facility: 
country: Greece
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.
PMID: 25548896
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.
PMID: 30322118
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.
PMID: 25791371
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.
PMID: 22187640
citation: 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
responsible party type: Principal Investigator
investigator affiliation: Harokopio University
investigator full name: Andriana C Kaliora
investigator title: Assosiate Professor in Foods and Human Nutrition
mesh term: Metabolic Syndrome