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Chestnut Consumption on Modulation of Gut Microbiota and Metabolic Parameters

NCT ID: NCT05705960

Last Updated: 2023-01-31

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-15

Study Completion Date

2023-03-31

Brief Summary

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The chestnut tree (Castanea sativa Mill.) is a species widely cultivated in Portugal, which is a major producer of chestnuts. Nuts are nutritionally interesting, not only because of their content of vitamins, minerals, and phytochemicals but also of their high fiber content.

Fiber, as it is not digested by humans, has a preponderant role in the intestinal microbiota, for its maintenance, and, consequently, has an impact on metabolic status.

The inclusion of foods rich in these components, and with extensive local production, can be an excellent strategy for improving the metabolic parameters of the population.

The main objective of this single group assignment clinical trial is to evaluate the effect of including roasted chestnuts in the daily diet on the composition and diversity of the intestinal microbiota. It is also intended to evaluate metabolic parameters to determine the impact of this intervention.

Detailed Description

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Conditions

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Diet Habit

Keywords

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Chestnut Gut microbiota diversity Short chain fatty acid Lipid

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Chestnut

Group Type EXPERIMENTAL

Chestnut

Intervention Type OTHER

Daily consumption of roasted chestnut (150g) for 14 days

Interventions

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Chestnut

Daily consumption of roasted chestnut (150g) for 14 days

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Caucasian.
* Filling informed consent.
* Body mass index (BMI) between 18,5 kg/m2 and 25 kg/m2.

Exclusion Criteria

* Chestnut sensibility.
* Chestnut daily consumption in the month before the study initiation.
* Having taken antibiotics within the 6 months prior to beginning the study;
* Use of pro/prebiotics or fiber as a dietary supplement or any food/molecule that modifies intestinal transit time 6 weeks before recruitment.
* Use of laxative 6 weeks before recruitment.
* Specific dietary regimen (e.g., vegan).
* Specific nutritional therapy (e.g. high protein).
* Excessive alcohol consumption.
* Smoking.
* Diagnosis of gastrointestinal pathology, hormonal or thyroid pathology, autoimmune diseases, chronic use of corticosteroids, psychiatric disease or Diabetes Mellitus.
* Use of proton pump inhibitors, antidiabetic drugs, insulin, or statins.
* Pregnant or breastfeeding.
* Participation in another clinical trial within the last 3 months.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Associação Centro de Apoio Tecnológico Agro-Alimentar de Castelo Branco (CATAA)

UNKNOWN

Sponsor Role collaborator

Universidade Nova de Lisboa

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ana Faria, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Nova de Lisboa

Locations

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Nova Medical School Universidade Nova de Lisboa

Lisbon, , Portugal

Site Status RECRUITING

Countries

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Portugal

Central Contacts

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Ana Faria, PhD

Role: CONTACT

Phone: 00351218803033

Email: [email protected]

Facility Contacts

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Catarina Rodrigues, Msc

Role: primary

Other Identifiers

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CULTIVAR

Identifier Type: -

Identifier Source: org_study_id