Dietary ModificationNCT02936362
Testing the Effect of Whole-wheat Sourdough Bread Compared to White Bread on Healthy Individuals
A study testing Consumption of sourdough bread and Consumption of white bread in people with Dietary Modification and Bread, run by Tel-Aviv Sourasky Medical Center at 2 sites in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Modification, Bread, Gastrointestinal Microbiome
- What is being tested?
- Consumption of sourdough bread and Consumption of white bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesIsrael
- Study dates
- Feb 2016to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to provide and signed informed consent form
- Over 18 years
- Not in active military service
- Ability to technically operate a glucometer
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Weizmann Institute of Science
Rehovot
Department of Gastroentherology
Tel Aviv, 64239
About this study
Official title: Testing the Effect of Whole-wheat Sourdough Bread Compared to White Bread on Healthy Individuals: Randomized Trial
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.
- Conditions
- Dietary Modification, Bread, Gastrointestinal Microbiome, Hematologic Tests, Body Weight Changes
- Being tested
- Consumption of sourdough bread, Consumption of white bread
- Keywords
- Bread, Microbiome, Blood tests, Sourdough bread, Dietary intervention
- Medical subject headings
- Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consumption of sourdough breadOther
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 breadOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Sourdough bread, white bread | Other | Consumption of sourdough bread for one week, 2 week washout, consumption of white bread for one week Receives: Other: Consumption of sourdough bread; Other: Consumption of white bread |
| White bread, sourdough bread | Other | Consumption of white bread for one week, 2 week washout, consumption of sourdough bread for one week Receives: Other: Consumption of sourdough bread; Other: Consumption of white bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes to glycemic control
Measured as response to an Oral Glucose Tolerance Test (OGTT; mg/dl*h).
Measured: One week
Changes to glycemic control
Measured as blood glucose levels at wake-up (mg/dl).
Measured: One week
Secondary outcomes (18)
Changes to total cholesterol levels (mg/dl)
Measured by a blood test.
Measured: One week
Changes to HDL cholesterol levels (mg/dl)
Measured by a blood test.
Measured: One week
Changes to LDL cholesterol levels (mg/dl)
Measured by a blood test.
Measured: One week
Changes to triglycerides levels (mg/dl)
Measured by a blood test.
Measured: One week
Changes to C-Reactive Protein (CRP) levels (mg/l)
Measured by a blood test.
Measured: One week
Changes to weight (Kg.)
Measured: One week
Changes to Basal Metabolic Rate (BMR; J)
Measured: One week
Changes to blood pressure (mmHg)
Measured: One week
Changes to Alanine Transaminase (ALT) levels (IU/l)
Measured by a blood test.
Measured: One week
Changes to Aspartate Transaminase (AST) levels (IU/I)
Measured by a blood test.
Measured: One week
Changes to Gamma-Glutamyl Transpeptidase (GGT) levels (IU/l)
Measured by a blood test.
Measured: One week
Changes to Creatinine levels (mg/dl)
Measured by a blood test.
Measured: One week
Changes to Magnesium levels (mg/dl)
Measured by a blood test.
Measured: One week
Changes to Calcium levels (mg/dl)
Measured by a blood test.
Measured: One week
Changes to Iron levels (mg/dl)
Measured by a blood test.
Measured: One week
Changes to Urea levels (mg/dl)
Measured by a blood test.
Measured: One week
Changes to Lactate Dehydrogenase (LDH) levels
Measured by a blood test (IU/l)
Measured: One week
Changes to Thyroid Stimulating Hormone (TSH)
Measured by a blood test (mIU/ml)
Measured: One week D
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startFeb 2016
- Primary completionMay 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary ModificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Weizmann Institute of Science
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936362
- Sponsor's protocol ID
- TASMC-12-ZH-658A
- Status last verified
- Oct 2016
- First submitted
- 13 Oct 2016
- Last updated
- 18 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effect of Whole-wheat Sourdough Bread Compared to White Bread on Healthy Individuals: Randomized Trial
- ClinicalTrials.gov ID
- NCT02936362
- Acronym / sponsor ID
- TASMC-12-ZH-658A
- Conditions
- Dietary Modification, Bread, Gastrointestinal Microbiome, Hematologic Tests, Body Weight Changes
- Keywords
- Bread, Microbiome, Blood tests, Sourdough bread, Dietary intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Weizmann Institute of Science
- Study start
- Feb 2016
- Primary completion
- May 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sourdough bread, white bread | Other | Other: Consumption of sourdough bread, Other: Consumption of white breadConsumption of sourdough bread for one week, 2 week washout, consumption of white bread for one week |
| White bread, sourdough bread | Other | Other: Consumption of sourdough bread, Other: Consumption of white breadConsumption of white bread for one week, 2 week washout, consumption of sourdough bread for one week |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to provide and signed informed consent form
- Over 18 years
- Not in active military service
- Ability to technically operate a glucometer
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Consumption of sourdough breadParticipants 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) | Other | Sourdough bread, white bread, White bread, sourdough bread |
| Consumption of white breadParticipants 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) | Other | Sourdough bread, white bread, White bread, sourdough bread |
Primary outcome
Changes to glycemic control
Time frame: One week
Measured as response to an Oral Glucose Tolerance Test (OGTT; mg/dl*h).
Changes to glycemic control
Time frame: One week
Measured as blood glucose levels at wake-up (mg/dl).
18 secondary outcomes
Changes to total cholesterol levels (mg/dl)
Time frame: One week
Changes to HDL cholesterol levels (mg/dl)
Time frame: One week
Changes to LDL cholesterol levels (mg/dl)
Time frame: One week
Changes to triglycerides levels (mg/dl)
Time frame: One week
Changes to C-Reactive Protein (CRP) levels (mg/l)
Time frame: One week
Changes to weight (Kg.)
Time frame: One week
Changes to Basal Metabolic Rate (BMR; J)
Time frame: One week
Changes to blood pressure (mmHg)
Time frame: One week
Changes to Alanine Transaminase (ALT) levels (IU/l)
Time frame: One week
Changes to Aspartate Transaminase (AST) levels (IU/I)
Time frame: One week
Changes to Gamma-Glutamyl Transpeptidase (GGT) levels (IU/l)
Time frame: One week
Changes to Creatinine levels (mg/dl)
Time frame: One week
Changes to Magnesium levels (mg/dl)
Time frame: One week
Changes to Calcium levels (mg/dl)
Time frame: One week
Changes to Iron levels (mg/dl)
Time frame: One week
Changes to Urea levels (mg/dl)
Time frame: One week
Changes to Lactate Dehydrogenase (LDH) levels
Time frame: One week
Changes to Thyroid Stimulating Hormone (TSH)
Time frame: One week D
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consumption of sourdough bread and Consumption of white bread in people with Dietary Modification and Bread, run by Tel-Aviv Sourasky Medical Center at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes to glycemic control (time frame: One week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2016.