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
Phase: NA
Conditions: Healthy
Sponsor: Harokopio University

 
                                                                                                                                             2021-03-04 
 
 
 
 
 
   NCT04759625 
 
 
 
 
 
 
INTERVENTIONTAL STUDY WITH TITLE: 
 
“Effect of a dietary intervention that includes daily 
consumption of a novel biscuit enriched with Greek 
edible mushrooms, rich in β-glucans, on intestinal health-
related parameters of healthy older adults: a randomized 
controlled trial” 
 
 
 
 
 
 
H A R O K O P I O  U N I V E R S I T Y  
 
SCHOOL OF HEALTH SCIENCE AND EDUCATION 
DEP ARTMENT OF NUTRITION AND DIETETICS  

 
                                                                                                                                             2021-03-04 
 
 
 
 
 
   NCT04759625 
Study Protocol 
This is a randomized controlled trial with a cross-over design. Participants  will 
participate in two 3-month dietary interventions in a random order (using a random-
number table), with a 2-month washout period: one of the interventions will include 
the daily consumption of a novel biscuit enriched with mushroom powder containing 
3g of β-glucans, whereas the control intervention includes the daily consumption of a 
placebo  biscuit. Basic socio-demographic information and medical history will be 
recorded for all volunteers. At baseline and at the end of each intervention, all 
participants will undergo a full assessment of gastrointestinal symptoms, memory-
orientation ability, dietary and physical activity habits. Body weight will be also 
monitored. Blood, urine and faecal samples will also be collected before and at the 
end of each intervention period. The impact of β-glucan consumption on the faecal 
microbiota will be estimated through 16SrRNA sequencing and by measuring selected 
microorganisms (q-PCR). Furthermore metabolic products (i.e. SCFAs) will be 
quantified.