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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-20

Study Completion Date

2022-12-15

Brief Summary

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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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Detailed Description

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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

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Biscuit enriched with mushroom powder

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Placebo biscuit

Daily consumption of a placebo biscuit

Group Type PLACEBO_COMPARATOR

Placebo biscuit

Intervention Type OTHER

Daily consumption of placebo biscuit

Interventions

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

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

Intervention Type OTHER

Placebo biscuit

Daily consumption of placebo biscuit

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes