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

Harokopio University37 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Healthy

Interventions

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

Eligibility

Sex: ALLMin age: 60 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Harokopio University

Kallithea, Athens, Greece

Outcomes

Primary Outcomes

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.

Time frame: 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.

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)

Secondary Outcomes

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)

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.

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)

Data from ClinicalTrials.gov

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