Effects of Wheat Flour Milling Method on Glycemic Response and Gastrointestinal Symptoms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-40
SponsorUniversity of Bergen
About this trial
The goal of this clinical trial is to learn if the way wheat flour is ground - by stone milling (an older method) or roller milling (used for most flour today) - changes blood sugar levels after eating bread, in healthy adults aged 20 to 40 who eat bread regularly. The main questions it aims to answer are:
Does bread made from stone-milled flour cause a smaller rise in blood sugar after breakfast than bread made from roller-milled flour? Does the milling method change stomach symptoms such as bloating?
Researchers will compare bread made from stone-milled wheat flour to bread made from roller-milled wheat flour, made from the same wheat and prepared the same way, to see if milling method changes blood sugar and stomach symptoms.
Participants will:
Eat the study bread at breakfast and lunch for 3 days, then switch to the other bread for 3 days, in a random order Eat a standard bread for a few days before each 3-day period Wear a small sensor that tracks blood sugar day and night for 14 days Keep a daily food diary, including photos of meals Answer online questionnaires about stomach symptoms
Eligibility criteria
This trial accepts healthy volunteersQualifiers
BMI 18.5-25 kg/m2
Healthy, defined by reference to the
Disqualifiers
Habitual consumption of bread on most days, at more than one meal per day
Willing and able to consume the study breads, to follow the standardized meal pattern for 14 days, and to wear a CGM sensor continuously for 14 days
Smoking/tobacco use
Any disease or condition or use of drugs or other compounds or treatments that could have a clinically significant impact on energy metabolism and/or gastrointestinal health (Roma IV to rule out IBS)
Trial design
Design model
Crossover
Treatments tested in this trial
Stone-milled wheat flour bread
Other interventionSourdough-fermented bread made from 100% wholegrain wheat flour milled by traditional stone milling (same wheat batch, starter, and fermentation protocol as the roller-milled bread). Consumed at breakfast and lunch, providing a fixed dose of available carbohydrate (\~50 g per meal, \~3 slices), for 3 consecutive days.
Roller-milled wheat flour bread (sourdough)
Other interventionSourdough-fermented bread made from 100% wholegrain wheat flour milled by conventional roller milling (same wheat batch, starter, and fermentation protocol as the stone-milled bread). Consumed at breakfast and lunch, providing the same fixed dose of available carbohydrate as the stone-millled bread, for 3 consecutive days.
Treatment groups
26 Participants
are divided into 2 treatment groupsGroup A: Sequence AB: Roller-Milled Sourdough Bread then Stone-Milled Sourdough BreadExperimental treatment 2 interventions
Group B: Sequence BA: Stone-Milled Sourdough Bread then Roller-Milled Sourdough BreadExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Incremental Area Under the Curve (iAUC) for postprandial glucose response to breakfast
Incremental area under the curve (iAUC, 0-180 minutes post-meal) for glucose following the standardized breakfast meal, calculated using the trapezoidal rule on continuous glucose monitoring (CGM) readings, counting only area above the pre-meal reference (mean CGM glucose in the 15 minutes before meal start). Evaluated as the average across evaluable breakfast meal-days (up to 3) within each 3-day intervention period.
Time frame
Days 4-6 (Intervention period 1) and days 11-13 (Intervention period 2)Secondary outcomes
1
Incremental Area Under the Curve (iAUC) for postprandial glucose response to lunch
Incremental area under the curve (iAUC, 0-180 minutes post-meal) for glucose following the standardized lunch meal, calculated using the trapezoidal rule on continuous glucose monitoring (CGM) readings, counting only area above the pre-meal reference (mean CGM glucose in the 15 minutes before meal start). Evaluated as the average across evaluable lunch meal-days (up to 3) within each 3-day intervention period.
Time frame
Days 4-6 (Intervention period 1) and Days 11-13 (Intervention period 2)2
Incremental Area Under the Curve (iAUC) for combined breakfast and lunch meals
Combined average postprandial glucose iAUC (0-180 minutes post-meal) calculated across all breakfast and lunch meals within each 3-day intervention period.
Time frame
Days 4-6 (Intervention period 1) and Days 11-13 (Intervention period 2)3
Peak postprandial glucose concentration
Maximum glucose concentration recorded within 180 minutes following breakfast and lunch bread meals, averaged across all meal occasions within each 3-day intervention period.
Time frame
Days 4-6 (Intervention period 1) and Days 11-13 (Intervention period 2)4
2-Hour postprandial glucose concentration
Glucose concentration at 120 minutes following the start of breakfast and lunch bread meals, averaged across all meal occasions within each 3-day intervention period.
Time frame
Days 4-6 (Intervention period 1) and Days 11-13 (Intervention period 2)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Bergen
Lead sponsor
Nofima
Collaborator
Source ClinicalTrials.gov