Testing the Effect of Whole-wheat Sourdough Bread Compared to White Bread on Healthy Individuals

NCT ID: NCT02936362

Last Updated: 2016-10-18

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-09-30

Brief Summary

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Bread is the most common grain product in the world, with consumption surpassing 3 billion individuals per year. Sourdough whole-grain bread is considered a healthy alternative to white, refined-wheat bread.

This cross-over study will test the effect of consumption of sourdough bread compared to white bread following a short dietary intervention period (one week) on multiple clinical parameters and gut microbiota.

Detailed Description

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Conditions

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Dietary Modification Bread Gastrointestinal Microbiome Hematologic Tests Body Weight Changes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Sourdough bread, white bread

Consumption of sourdough bread for one week, 2 week washout, consumption of white bread for one week

Group Type OTHER

Consumption of sourdough bread

Intervention Type OTHER

Participants will be given sourdough bread to consume instead of other wheat products. 145g will be consumed every morning in addition to ad libitum consumption throughout the day (matched between first and second intervention periods)

Consumption of white bread

Intervention Type OTHER

Participants will be given white bread to consume instead of other wheat products. 110g will be consumed every morning in addition to ad libitum consumption throughout the day (matched between first and second intervention periods)

White bread, sourdough bread

Consumption of white bread for one week, 2 week washout, consumption of sourdough bread for one week

Group Type OTHER

Consumption of sourdough bread

Intervention Type OTHER

Participants will be given sourdough bread to consume instead of other wheat products. 145g will be consumed every morning in addition to ad libitum consumption throughout the day (matched between first and second intervention periods)

Consumption of white bread

Intervention Type OTHER

Participants will be given white bread to consume instead of other wheat products. 110g will be consumed every morning in addition to ad libitum consumption throughout the day (matched between first and second intervention periods)

Interventions

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Consumption of sourdough bread

Participants will be given sourdough bread to consume instead of other wheat products. 145g will be consumed every morning in addition to ad libitum consumption throughout the day (matched between first and second intervention periods)

Intervention Type OTHER

Consumption of white bread

Participants will be given white bread to consume instead of other wheat products. 110g will be consumed every morning in addition to ad libitum consumption throughout the day (matched between first and second intervention periods)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Able to provide and signed informed consent form
* Over 18 years
* Not in active military service
* Ability to technically operate a glucometer

Exclusion Criteria

* Prediagnosed type I / type II diabetes mellitus
* Pregnancy
* Usage of antibiotics within three months prior to participation
* Chronically active inflammatory or neoplastic disease in the three years prior to enrollment
* Skin disease, including contact dermatitis, precluding proper attachment of the continuous glucose monitor
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Weizmann Institute of Science

OTHER

Sponsor Role collaborator

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Weizmann Institute of Science

Rehovot, , Israel

Site Status

Department of Gastroentherology

Tel Aviv, , Israel

Site Status

Countries

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Israel

Other Identifiers

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TASMC-12-ZH-658A

Identifier Type: -

Identifier Source: org_study_id

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