Clinical trial NCT04759625: Effect of Daily Consumption of a Novel Biscuit Enriched With Edible Mushrooms, on Intestinal Health-related Parameters
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: β-glucans
edible mushrooms
functional food
prebiotic activity
gut microbiota
older adults
Lead sponsor: Harokopio University
Sponsor class: OTHER
Collaborators: name: Agricultural University of Athens
name: National Hellenic Research Foundation
name: PAPADOPOULOS S.A
First posted: 2021-02-18
Enrollment: 37
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* healthy individuals aged 60-80 years old, of both sexes/genders

Exclusion Criteria:

* no recent weight loss and extreme dietary behaviors;
* no history of gastrointestinal disease, chronic constipation, chronic/acute diarrhea, autoimmune disease, coronary disease, liver and/or kidney malfunction;
* no consumption of antibiotics two months prior to the initiation of the intervention;
* no consumption of probiotics and/or prebiotics and/or dietary fiber supplements two weeks prior to the initiation of the intervention.

Primary outcomes:
measure: Change from baseline in Gastrointestinal tolerance of novel biscuit during the interventional period and at 3 months.
timeFrame: Gastrointestinal symptoms will be evaluated at baseline, during and at the end of each intervention. (3 months period)
measure: Change from baseline to the effect on the intestinal microbial populations and their metabolic products [i.e. Short-Chain Fatty Acids (SCFA)] (prebiotic effect) at 3 months.
timeFrame: The levels of microbial populations and their metabolic products e.g. SCFA will be measured at baseline and at the end of each interventional period.(3 months period)
Secondary outcomes:
measure: Change from baseline in Metabolic health at 3 months.
timeFrame: Metabolic health will be measured at baseline and at the end of each interventional period.(3 months period)
measure: Change from baseline in blood serum Insulin at 3 months.
timeFrame: Blood serum Insulin will be measured at baseline and at the end of each interventional period.(3 months period)
measure: Change from baseline in blood serum 25-hydroxy vitamin D at 3 months.
timeFrame: Blood serum 25-hydroxy vitamin D will be measured at baseline and at the end of each interventional period.(3 months period)
measure: Change from baseline in blood serum Parathyroid Hormone at 3 months.
timeFrame: Blood serum Parathyroid Hormone will be measured at baseline and at the end of each interventional period.(3 months period)
measure: Change from baseline in Immune system reinforcement at 3 months.
timeFrame: Immune system reinforcement will be measured at baseline and at the end of each interventional period.(3 months period)
measure: Change from baseline in Dietary intake at 3 months.
timeFrame: Dietary intake will be measured at baseline and at the end of each interventional period.(3 months period)
Other outcomes:
Locations:
city: Kallithea
country: Greece
facility: Harokopio University
state: Athens
Study officials:
affiliation: Harokopio University of Athens
name: Adamantini Kyriacou
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mitsou EK, Saxami G, Stamoulou E, Kerezoudi E, Terzi E, Koutrotsios G, Bekiaris G, Zervakis GI, Mountzouris KC, Pletsa V, Kyriacou A. Effects of Rich in Beta-Glucans Edible Mushrooms on Aging Gut Microbiota Characteristics: An In Vitro Study. Molecules. 2020 Jun 18;25(12):2806. doi: 10.3390/molecules25122806.
citation: Boulaka A, Christodoulou P, Vlassopoulou M, Koutrotsios G, Bekiaris G, Zervakis GI, Mitsou EK, Saxami G, Kyriacou A, Zervou M, Georgiadis P, Pletsa V. Genoprotective Properties and Metabolites of beta-Glucan-Rich Edible Mushrooms Following Their In Vitro Fermentation by Human Faecal Microbiota. Molecules. 2020 Aug 4;25(15):3554. doi: 10.3390/molecules25153554.
citation: Mitsou EK, Kakali A, Antonopoulou S, Mountzouris KC, Yannakoulia M, Panagiotakos DB, Kyriacou A. Adherence to the Mediterranean diet is associated with the gut microbiota pattern and gastrointestinal characteristics in an adult population. Br J Nutr. 2017 Jun;117(12):1645-1655. doi: 10.1017/S0007114517001593.