- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02570880
Effect of Dough Fermentation Time of Bread on the Glycaemic Index (SLOWBREAD)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Canton Zürich
-
Wädenswil, Canton Zürich, Switzerland, 8820
- ZHAW, Zurich Univeristy of Applied Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Bread sample vs. glucose solution
glycemic index
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
2 hours for each sample, 7 samples total, on non consecutive days, over 4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Beatrice E Baumer, MSc, MPH, ZHAW, Zurich University of Applied Science, Wädenswil, Switzerland
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SLOWBREAD-15-1
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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