NCT04759625

Effect of Daily Consumption of a Novel Biscuit Enriched With Edible Mushrooms, on Intestinal Health-related Parameters

Development of a Novel Biscuit Enriched With β-glucans Isolated From Edible Mushrooms of Greek Habitats and Implementation of a Dietary Intervention That Includes Daily Consumption of This Biscuit

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Harokopio University · Academic / Other
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to assess the effect of dietary intervention that includes the daily consumption of a novel biscuit (enriched with the selected mushrooms rich in β-glucans) on gut health related parameters of healthy subjects over 60 years old.

Detailed description

After having been informed about the study and the potential risks, all subjects giving written informed consent will undergo screening to determine eligibility for study entry (inclusion criteria). At baseline, the participants will provide biological samples and they will be randomly assigned in a double-blind manner (investigator and participant) to one of the intervention groups, i.e. consumption of the novel biscuit (biscuit enriched with mushroom powder containing 3g of β-glucans) or consumption of the placebo biscuit for 3 months,. After a washout period of 2 months, the subjects will consume the novel biscuit or the placebo biscuit in a cross-over design for 3 more months. Throughout the interventional period subjects' dietary intake, anthropometrical data and gastrointestinal symptoms will be monitored. Meanwhile at baseline and at the end of each trimester physical activity, mental health and sleep habits will be evaluated with the use of questionnaires and biological samples will be provided for further analysis.

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	Novel biscuit enriched with mushroom powder containing 3g of β-glucans	Daily consumption of a novel biscuit enriched with mushroom powder containing 3g of β-glucans
OTHER	Placebo biscuit	Daily consumption of placebo biscuit

Timeline

• Start date: 2021-02-20
• Primary completion: 2022-12-15
• Completion: 2022-12-15
• First posted: 2021-02-18
• Last updated: 2024-02-28

Locations

1 site across 1 country: Greece