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Completed

NCT Number: NCT04759625

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

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.

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Key information

Conditions

Healthy

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harokopio University

Kallithea, Athens, 176 71, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Placebo biscuit

Other

Daily consumption of placebo biscuit

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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)

    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)

  2. 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)

    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)

  3. 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)

    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)

  4. 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)

    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)

  5. 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)

    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.

  6. 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)

    Dietary intake will be evaluated with the use of 3-days (2-weekdays and 1 weekend day) diet intake records.

Sponsors and collaborators

Lead sponsor

Harokopio University

Other

Collaborators

  • Agricultural University of Athens
  • National Hellenic Research Foundation
  • PAPADOPOULOS S.A

Registry information

Official study 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

Acronym: FUNglucan

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 18, 2021
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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