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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02570880
Other study ID # SLOWBREAD-15-1
Secondary ID
Status Enrolling by invitation
Phase N/A
First received October 2, 2015
Last updated October 7, 2015
Start date October 2015
Est. completion date December 2015

Study information

Verified date October 2015
Source Zurich University of Applied Sciences
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial Summary

This study evaluates the impact of dough fermentation times on the glycaemic index of the ensuing breads.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 15
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 65 Years
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Other:
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

Locations

Country Name City State
Switzerland ZHAW, Zurich Univeristy of Applied Sciences Wädenswil Canton Zürich

Sponsors (1)

Lead Sponsor Collaborator
Beatrice Baumer

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 2 hours for each sample, 7 samples total, on non consecutive days, over 4 weeks No