Health Effects of Different Types of Bread (HELFAB)

May 11, 2021 updated by: Oslo Metropolitan University

Health Effects and Consumer Aspects of Different Types of Bread

Dietary fiber is well known to have health promoting effects, including reduced blood glucose and cholesterol levels. Bread is the most important source of dietary fiber in the Norwegian diet. Production of bread has changed from the traditionally use of sourdough, to yeast (Saccharomyces cerevisiae) as the dominating leavening agent in modern industrial production. Sourdough naturally contains bacteria, and through the fermentation process these bacteria release several components that are not found in modern bread using yeast. It has been shown that sourdough may have positive health effects, including on blood glucose regulation. The aim of the project is to investigate if intake of sourdough may give positive health effects compared to beard with yeast.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators aim to include approximately 20 participants in this randomized controlled double-blind cross-over study lasting for 5 weeks.

All participants will be given bread baked with yeast for a 2 weeks run-in period. The participants will then be randomly assigned to either 1 week intervention with bread baked with yeast or sourdough, before a 1 week wash-out period with yeast bread. During the last 1 week intervention period the participants starting with bread baked with yeast will be given sourdough and vice versa.

Questionnaires (GSRS-IBS, BSC, FFQ), blood samples, and feces samples will be collected before and after the intervention periods.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0130
        • Vibeke Telle-Hansen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy adults who restrict their intake of bread due to stomach ache.

Exclusion Criteria:

  • Chronic metabolic diseases, such as diabetes type 1 or 2, cardiovascular diseases and cancer last 6 months
  • Gut diseases, including Chron's disease, ulcers colitis
  • Food allergies or intolerance
  • Pregnant and/or lactating
  • Smokers
  • BMI <18,5 and >27 kg/m2
  • Planed weight reduction and/or ± 5% weight change last 3 months
  • Blood donor last 2 months and during the study period
  • Not willing to quit taking dietary supplements, including probiotics, cod liver oil etc., 4 weeks prior to study start and during the study
  • Use of antibiotics <3 months prior to study start and during the study
  • Alcohol intake >40 g/day
  • Hormone treatment (except contraceptives)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Wholegrain bread with yeast
The control group will be given min. 5 slices of bread baked with yeast per day.
Other: Intervention group
intervention group: bread with sourdough control group: bread with yeast
Experimental: Wholegrain bread with sourdough
The experimental group will be given min. 5 slices of bread baked with sourdough per day.
Other: Intervention group
intervention group: bread with sourdough control group: bread with yeast

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Gastrointestinal Symptom Rating Scale-irritable bowl syndrome (GSRS-IBS)
Time Frame: 5 weeks
GSRS-IBS analysis after intervention with bread baked with yeast versus sourdough with the following response scale: 1 (no discomfort at all) to 7 (very severe discomfort)
5 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bristol stool chart (BSC)
Time Frame: 5 weeks
BSC analyses after intervention with bread baked with yeast versus sourdough with a scale from 1 (separate hard lumps, like nuts) to 7 (watery, no solid pieces)
5 weeks
Blood C-peptide, total cholesterol, triglycerides, fatty acid profile, and short chain fatty acids
Time Frame: 5 weeks
Blood analyses of C-peptide, total cholesterol, triglycerides, fatty acid profile, and short chain fatty acids after intervention with bread baked with yeast versus sourdough
5 weeks
Feces microbiota analysis performed with Bio-Me's Precision Microbiome Profiling platform (PMP™)
Time Frame: 5 weeks
Feces analyses of microbiota after intervention with bread baked with yeast versus sourdough
5 weeks
Iron, selenium and zinc in blood
Time Frame: 5 weeks
Blood analysis of iron, selenium and zinc after intervention with bread baked with yeast versus sourdough
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oslo Metropolitan University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Oslo
Mesterbakeren

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vibeke Telle-Hansen, PhD, Oslo and Akershus University College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 96264

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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