Glycemic Index (MeSH T483740)SLOWBREADNCT02570880
Effect of Dough Fermentation Time of Bread on the Glycaemic Index
A study testing glycemic index (glucose-solution, bread samples) in people with Glycemic Index (MeSH T483740), run by Beatrice Baumer at 1 site in Switzerland.
Trial summary
This study evaluates the impact of dough fermentation times on the glycaemic index of the ensuing breads. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycemic Index (MeSH T483740)
- What is being tested?
- glycemic index (glucose-solution, bread samples)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2015to Dec 2015
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- no known food allergy or intolerance;
- no medications known to affect glucose tolerance (excluding oral contraceptives)
- stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable.
Who cannot join
- a known history of diabetes mellitus or the use of antihyperglycaemic drugs or insulin to treat diabetes and related conditions;
- a major medical or surgical event requiring hospitalization within the preceding 3 months;
- the presence of disease or drug(s) which influence digestion and absorption of nutrients;
- the use of steroids, protease inhibitors or antipsychotics
- pregnancy / breastfeeding
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
ZHAW, Zurich Univeristy of Applied Sciences
Wädenswil, Canton Zürich, 8820
About this study
This study evaluates the impact of dough fermentation times on the glycaemic index of the ensuing breads.
Read the detailed description
The worldwide prevalence for non-communicable diseases (NCD) is increasing, nutrition is considered to be one of the main modifiable risk factors. An unhealthy diet leads to obesity, which is a further risk factor for NCDs. Excessive carbohydrates but also the nutritional quality of carbohydrates, can be elements defining "unhealthy diets". The nutritional quality of carbohydrates can be expressed as the glycaemic index.
Fermentation time of bread dough could affect the ensuing bread quality to such an extent that it influences ist glycaemic index. If this hypothesis is confirmed, the process of breadmaking could be optimized in order to offer healthier bread varieties on the market.
- Conditions
- Glycemic Index (MeSH T483740)
- Being tested
- glycemic index (glucose-solution, bread samples)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glycemic index (glucose-solution, bread samples)Other
All participants will test 2 breads, prepared with different fermentation times of dough, both breads will be tested in duplicate. Methode: International Organization for Standardization / Final Draft International Standard 26642, Food products - Determination of the glycaemic index (GI) and recommendation for food classification
| Study group | Role | What they receive |
|---|---|---|
| Bread sample vs. glucose solution | Experimental | glycemic index Receives: Other: glycemic index (glucose-solution, bread samples) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postprandial glycemia: Glucose in capillary blood samples over 2 hours (blood samples every 15 minutes), after oral intake of bread samples or glucose-solution (reference)
a drop of capillary blood will be taken every 15 minutes after ingestion of a bread sample containing 50 g of available carbohydrates
Measured: 2 hours for each sample, 7 samples total, on non consecutive days, over 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic Index (MeSH T483740)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beatrice Baumer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Beatrice Baumer, Zurich University of Applied Sciences
- Investigators
- Beatrice E Baumer, MSc, MPH, Principal investigator, ZHAW, Zurich University of Applied Science, Wädenswil, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570880
- Sponsor's protocol ID
- SLOWBREAD-15-1
- Acronym
- SLOWBREAD
- Status last verified
- Oct 2015
- First submitted
- 2 Oct 2015
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dough Fermentation Time of Bread on the Glycaemic Index
- ClinicalTrials.gov ID
- NCT02570880
- Acronym / sponsor ID
- SLOWBREAD / SLOWBREAD-15-1
- Conditions
- Glycemic Index (MeSH T483740)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Beatrice BaumerUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 7 Oct 2015 (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.
This study evaluates the impact of dough fermentation times on the glycaemic index of the ensuing breads.
Detailed description
The worldwide prevalence for non-communicable diseases (NCD) is increasing, nutrition is considered to be one of the main modifiable risk factors. An unhealthy diet leads to obesity, which is a further risk factor for NCDs. Excessive carbohydrates but also the nutritional quality of carbohydrates, can be elements defining "unhealthy diets". The nutritional quality of carbohydrates can be expressed as the glycaemic index.
Fermentation time of bread dough could affect the ensuing bread quality to such an extent that it influences ist glycaemic index. If this hypothesis is confirmed, the process of breadmaking could be optimized in order to offer healthier bread varieties on the market.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bread sample vs. glucose solution | Experimental | Other: glycemic index (glucose-solution, bread samples)glycemic index |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- no known food allergy or intolerance;
- no medications known to affect glucose tolerance (excluding oral contraceptives)
- stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable.
Key exclusion criteria (5 listed)
- a known history of diabetes mellitus or the use of antihyperglycaemic drugs or insulin to treat diabetes and related conditions;
- a major medical or surgical event requiring hospitalization within the preceding 3 months;
- the presence of disease or drug(s) which influence digestion and absorption of nutrients;
- the use of steroids, protease inhibitors or antipsychotics
- pregnancy / breastfeeding
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 |
|---|---|---|
| glycemic index (glucose-solution, bread samples)All participants will test 2 breads, prepared with different fermentation times of dough, both breads will be tested in duplicate. Methode: International Organization for Standardization / Final Draft International Standard 26642, Food products - Determination of the glycaemic index (GI) and recommendation for food classification | Other | Bread sample vs. glucose solution |
Primary outcome
Change in postprandial glycemia: Glucose in capillary blood samples over 2 hours (blood samples every 15 minutes), after oral intake of bread samples or glucose-solution (reference)
Time frame: 2 hours for each sample, 7 samples total, on non consecutive days, over 4 weeks
a drop of capillary blood will be taken every 15 minutes after ingestion of a bread sample containing 50 g of available carbohydrates
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
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.
Beatrice E Baumer, MSc, MPH principal investigator
ZHAW, Zurich University of Applied Science, Wädenswil, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing glycemic index (glucose-solution, bread samples) in people with Glycemic Index (MeSH T483740), run by Beatrice Baumer at 1 site in Switzerland.
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 3 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: status not confirmed, as of the sponsor's last update on 8 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Results are not available in the source record.
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?
Change in postprandial glycemia: Glucose in capillary blood samples over 2 hours (blood samples every 15 minutes), after oral intake of bread samples or glucose-solution (reference) (time frame: 2 hours for each sample, 7 samples total, on non consecutive days, over 4 weeks). 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 8 Oct 2015.