HealthyFUNglucanNCT04759625
Effect of Daily Consumption of a Novel Biscuit Enriched With Edible Mushrooms, on Intestinal Health-related Parameters
A study testing Novel biscuit enriched with mushroom powder containing 3g of β-glucans in people with Healthy, run by Harokopio University at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Novel biscuit enriched with mushroom powder containing 3g of β-glucans
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteGreece
- Study dates
- 20 Feb 2021to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy individuals aged 60-80 years old, of both sexes/genders
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Novel biscuit enriched with mushroom powder containing 3g of β-glucans, Placebo biscuit
- Keywords
- β-glucans, edible mushrooms, functional food, prebiotic activity, gut microbiota, older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel biscuit enriched with mushroom powder containing 3g of β-glucansOther
Daily consumption of a novel biscuit enriched with mushroom powder containing 3g of β-glucans
Placebo biscuitOther
Daily consumption of placebo biscuit
| Study group | Role | What they receive |
|---|---|---|
| Biscuit enriched with mushroom powder | Experimental | Daily consumption of a novel biscuit enriched with mushroom powder containing 3g of β-glucans Receives: Other: Novel biscuit enriched with mushroom powder containing 3g of β-glucans |
| Placebo biscuit | Placebo comparator | Daily consumption of a placebo biscuit Receives: Other: Placebo biscuit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Gastrointestinal tolerance of novel biscuit during the interventional period and at 3 months.
Gastrointestinal (GI) symptomatology will be recorded through a 7d-questionnaire in certain time periods.The intensity of each GI symptom (abdominal pain, distension, flatulence and borborygmi) will be measured daily on a scale of 0-4, where '0' represents absence of symptoms and '4' severe symptoms. The possible range for each weekly symptom score is 0-28, and for the total symptom score 0-112. Frequency and consistency of evacuations will be also noted, and presence of diarrhoea will be defined.
Measured: Gastrointestinal symptoms will be evaluated at baseline, during and at the end of each intervention. (3 months period)
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.
Microbial populations will be quantified with 16SRNA sequencing and quantitative Polymerase Chain Reaction (PCR). SCFAs will be quantified with Gas chromatography.
Measured: 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 (6)
Change from baseline in Metabolic health at 3 months.
Blood samples will be obtained after an overnight, 12-h fasting. Blood serum analysis will include assessment of lipidemic profile [i.e. Total Cholesterol (TC), Low-Density Lipoprotein Cholesterol (LDL-C), High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG)], glucose metabolism [i.e. Fasting Blood Glucose (FBG)] and uric acid. (units of measure: mg/dL)
Measured: Metabolic health will be measured at baseline and at the end of each interventional period.(3 months period)
Change from baseline in blood serum Insulin at 3 months.
Blood samples will be obtained after an overnight, 12-h fasting. Blood serum analysis will include assessment of glucose metabolism [i.e. Insulin (INS)]. (units of measure: μIU/mL)
Measured: Blood serum Insulin will be measured at baseline and at the end of each interventional period.(3 months period)
Change from baseline in blood serum 25-hydroxy vitamin D at 3 months.
Blood samples will be obtained after an overnight, 12-h fasting. Blood serum analysis will include assessment of bone biomarkers (i.e. 25-hydroxy vitamin D).(units of measure: ng/mL)
Measured: Blood serum 25-hydroxy vitamin D will be measured at baseline and at the end of each interventional period.(3 months period)
Change from baseline in blood serum Parathyroid Hormone at 3 months.
Blood samples will be obtained after an overnight, 12-h fasting. Blood serum analysis will include assessment of bone biomarker [i.e. Parathyroid Hormone (PTH)].(units of measure: pg/mL)
Measured: Blood serum Parathyroid Hormone will be measured at baseline and at the end of each interventional period.(3 months period)
Change from baseline in Immune system reinforcement at 3 months.
The production of Interleukins (IL) (i.e. IL-1β, IL-6, IL-10) and Tumor-necrosis factor alpha (TNF-a) in vitro by peripheral blood mononuclear cells (PBMCs) cultured and isolated from healthy immunocompetent subjects, after mitogen stimulation, will be determined in cell culture supernatants by ELISA techniques with commercially available kits. The cytokine expression levels will be determined in cell pellets by Quantitative Real Time Polymerase Chain Reaction (qRT-PCR). Concomitantly, the levels of the same cytokines will be assessed by ELISA in the serum collected from the same subjects.
Measured: Immune system reinforcement will be measured at baseline and at the end of each interventional period.(3 months period)
Change from baseline in Dietary intake at 3 months.
Dietary intake will be evaluated with the use of 3-days (2-weekdays and 1 weekend day) diet intake records.
Measured: Dietary intake will be measured at baseline and at the end of each interventional period.(3 months period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start20 Feb 2021
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harokopio University
- Sponsor type
- University, hospital or other
- Collaborators
- Agricultural University of Athens, National Hellenic Research Foundation, PAPADOPOULOS S.A
- Responsible party
- Principal investigator, Adamantini Kyriakou, Harokopio University
- Investigators
- Adamantini Kyriacou, Principal investigator, Harokopio University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759625
- Sponsor's protocol ID
- T1EDK-03404
- Acronym
- FUNglucan
- Status last verified
- Feb 2024
- First submitted
- 3 Feb 2021
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32570735Boulaka 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.
PubMed 32759726Mitsou 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.
PubMed 28789729
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04759625
- Acronym / sponsor ID
- FUNglucan / T1EDK-03404
- Conditions
- Healthy
- Keywords
- β-glucans, edible mushrooms, functional food, prebiotic activity, gut microbiota, older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Harokopio UniversityUniversity, hospital or other
- Collaborators
- Agricultural University of Athens, National Hellenic Research Foundation, PAPADOPOULOS S.A
- Study start
- 20 Feb 2021 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biscuit enriched with mushroom powder | Experimental | Other: Novel biscuit enriched with mushroom powder containing 3g of β-glucansDaily consumption of a novel biscuit enriched with mushroom powder containing 3g of β-glucans |
| Placebo biscuit | Placebo comparator | Other: Placebo biscuitDaily consumption of a placebo biscuit |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy individuals aged 60-80 years old, of both sexes/genders
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel biscuit enriched with mushroom powder containing 3g of β-glucansDaily consumption of a novel biscuit enriched with mushroom powder containing 3g of β-glucans | Other | Biscuit enriched with mushroom powder |
| Placebo biscuitDaily consumption of placebo biscuit | Other | Placebo biscuit |
Primary outcome
Change from baseline in Gastrointestinal tolerance of novel biscuit during the interventional period and at 3 months.
Time frame: Gastrointestinal symptoms will be evaluated at baseline, during and at the end of each intervention. (3 months period)
Gastrointestinal (GI) symptomatology will be recorded through a 7d-questionnaire in certain time periods.The intensity of each GI symptom (abdominal pain, distension, flatulence and borborygmi) will be measured daily on a scale of 0-4, where '0' represents absence of symptoms and '4' severe symptoms. The possible range for each weekly symptom score is 0-28, and for the total symptom score 0-112. Frequency and consistency of evacuations will be also noted, and presence of diarrhoea will be defined.
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.
Time frame: 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)
Microbial populations will be quantified with 16SRNA sequencing and quantitative Polymerase Chain Reaction (PCR). SCFAs will be quantified with Gas chromatography.
6 secondary outcomes
Change from baseline in Metabolic health at 3 months.
Time frame: Metabolic health will be measured at baseline and at the end of each interventional period.(3 months period)
Change from baseline in blood serum Insulin at 3 months.
Time frame: Blood serum Insulin will be measured at baseline and at the end of each interventional period.(3 months period)
Change from baseline in blood serum 25-hydroxy vitamin D at 3 months.
Time frame: Blood serum 25-hydroxy vitamin D will be measured at baseline and at the end of each interventional period.(3 months period)
Change from baseline in blood serum Parathyroid Hormone at 3 months.
Time frame: Blood serum Parathyroid Hormone will be measured at baseline and at the end of each interventional period.(3 months period)
Change from baseline in Immune system reinforcement at 3 months.
Time frame: Immune system reinforcement will be measured at baseline and at the end of each interventional period.(3 months period)
Change from baseline in Dietary intake at 3 months.
Time frame: Dietary intake will be measured at baseline and at the end of each interventional period.(3 months period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Background: PubMed 32570735Mitsou 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.
- Background: PubMed 32759726Boulaka 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.
- Background: PubMed 28789729Mitsou 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.
- Project's official website.Link provided by the sponsor.
- Project's official facebook website.Link provided by the sponsor.
- Project's official instagram website.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adamantini Kyriacou principal investigator
Harokopio University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel biscuit enriched with mushroom powder containing 3g of β-glucans in people with Healthy, run by Harokopio University at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Gastrointestinal tolerance of novel biscuit during the interventional period and at 3 months. (time frame: Gastrointestinal symptoms will be evaluated at baseline, during and at the end of each intervention. (3 months period)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04759625, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.