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

NCT04759625 | Completed

• 1 other identifier: T1EDK-03404
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

β-glucans; edible mushrooms; functional food; prebiotic activity; gut microbiota; older adults

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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.

  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 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 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 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.

  Immune system reinforcement will be measured at baseline and at the end of each interventional period.(3 months period)

Study Arms (2)

Biscuit enriched with mushroom powder

EXPERIMENTAL

Daily consumption of a novel biscuit enriched with mushroom powder containing 3g of β-glucans

Other: Novel biscuit enriched with mushroom powder containing 3g of β-glucans

Placebo biscuit

PLACEBO COMPARATOR

Daily consumption of a placebo biscuit

Other: Placebo biscuit

Interventions

Novel biscuit enriched with mushroom powder containing 3g of β-glucans OTHER

Daily consumption of a novel biscuit enriched with mushroom powder containing 3g of β-glucans

Biscuit enriched with mushroom powder

Placebo biscuit OTHER

Daily consumption of placebo biscuit

Placebo biscuit

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harokopio University: lead
• Agricultural University of Athens: collaborator
• National Hellenic Research Foundation: collaborator
• PAPADOPOULOS S.A: collaborator

Study Sites (1)

Harokopio University

Kallithea, Athens, 176 71, Greece

Location

Related Publications (3)

• 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.

  PMID: 32570735 BACKGROUND

• 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.

  PMID: 32759726 BACKGROUND

• 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.

  PMID: 28789729 BACKGROUND

Related Links

• Project's official website.
• Project's official facebook website.
• Project's official instagram website.

Study Officials

• Adamantini Kyriacou

  Harokopio University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 18, 2021
• Study Start: February 20, 2021
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)