Postprandial Glucose, Insulin Responses and Appetite Hormones to Dried Mushrooms

Sponsor
Harokopio University (Other)
Overall Status
Completed
CT.gov ID
NCT04444219
Collaborator
(none)
19
1
2
14
1.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Breakfast meals
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Postprandial Glucose, Insulin Responses and Appetite Hormones to Dried Mushrooms
Actual Study Start Date :
Jun 1, 2020
Actual Primary Completion Date :
Mar 31, 2021
Actual Study Completion Date :
Jul 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: Breakfast meal_1

100 g white bread, 40 g yellow cheese and Κing Oyster mushrooms (test meal)

Other: Breakfast meals
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)

Other: Breakfast meals
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.

Outcome Measures

Primary Outcome Measures

  1. Difference of Glucose levels [1 month]

    Difference of Glucose levels after consuming the two meals

  2. Difference of Insulin levels [1 month]

    Difference of insulin levels after consuming the two meals

  3. Difference of appetite hormones levels [1 month]

    Difference of appetite hormones levels after consuming the two meals

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 54 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Andriana Kaliora Athens Greece 17671

Sponsors and Collaborators

  • Harokopio University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Andriana C Kaliora, Assosiate Professor in Foods and Human Nutrition, Harokopio University
ClinicalTrials.gov Identifier:
NCT04444219
Other Study ID Numbers:
  • Nutritious_Mushrooms_Postprand
First Posted:
Jun 23, 2020
Last Update Posted:
Sep 27, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 27, 2021