Postprandial Glucose, Insulin Responses and Appetite Hormones to Dried Mushrooms

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Other: Breakfast meals

• Registration Number: NCT04444219
• Lead Sponsor: Harokopio University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2020-06-20
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-23
• Primary Completion: 2021-03-31
• Study Completion: 2021-07-31
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Breakfast meal_1	Breakfast meals	100 g white bread, 40 g yellow cheese and Κing Oyster mushrooms (test meal)
Breakfast meal_2	Breakfast meals	100 g white bread, 40 g yellow cheese and 6-7 cherry tomatoes (control meal)

Primary Outcome Measures

Name	Time	Method
Difference of Insulin levels	1 month	Difference of insulin levels after consuming the two meals
Difference of Glucose levels	1 month	Difference of Glucose levels after consuming the two meals
Difference of appetite hormones levels	1 month	Difference of appetite hormones levels after consuming the two meals

Trial Locations

Locations (1)

Andriana Kaliora; 🇬🇷 Athens, Greece