NCT04444219

Postprandial Glucose, Insulin Responses and Appetite Hormones to Dried Mushrooms

Completed NA Last updated 27 September 2021

What this trial tests

NA trial testing Breakfast meals in Metabolic Syndrome in 19 participants. Completed in 31 July 2021.

Timeline

1 June 2020

Primary endpoint
31 March 2021

31 July 2021

Quick facts

Lead sponsor	Harokopio University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	prevention
Enrollment	19
Start date	1 June 2020
Primary completion	31 March 2021
Estimated completion	31 July 2021
Sites	1 location across Greece

Drugs / interventions tested

• Breakfast meals

Conditions studied

• Metabolic Syndrome — all drugs for Metabolic Syndrome →

Sponsor

Harokopio University

Who can join

Adults 18 to 54, any sex, with Metabolic Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Performance of <i>Pleurotus eryngii</i> β-Glucans on Protein Digestion and the Release of Free Amino Acids in the Bloodstream of Obese Adults.
   Amerikanou C, Kleftaki SA, Gioxari A, Tagkouli D, et al · · 2025 · PMID 40807584 · DOI 10.3390/foods14152649