Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Appetite measurements |
Appetite in response to test meal, will be measured using 100 millimeter (mm) Visual Analogue Scales (VAS) before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes). |
During test day 1 (up to 4 hours) |
|
Primary |
Appetite measurements |
Appetite in response to test meal, will be measured using 100 millimeter (mm) Visual Analogue Scales (VAS) before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes). |
During test day 2 (up to 4 hours) |
|
Primary |
Appetite measurements |
Appetite in response to test meal, will be measured using 100 millimeter (mm) Visual Analogue Scales (VAS) before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes). |
During test day 3 (up to 4 hours) |
|
Primary |
Food intake at subsequent meal |
Weighted amounts of ad-libitum food offered minus the weighted leftovers |
During test day 1 (240 minutes after ingestion of breakfast) |
|
Primary |
Food intake at subsequent meal |
Weighted amounts of ad-libitum food offered minus the weighted leftovers |
During test day 2 (240 minutes after ingestion of breakfast) |
|
Primary |
Food intake at subsequent meal |
Weighted amounts of ad-libitum food offered minus the weighted leftovers |
During test day 3 (240 minutes after ingestion of breakfast) |
|
Secondary |
Oral processing behaviour |
Participants will be video-recorded to measure oral processing behaviour of the test meal |
During test day 1 (up to 15 minutes) |
|
Secondary |
Oral processing behaviour |
Participants will be video-recorded to measure oral processing behaviour of the test meal |
During test day 2 (up to 15 minutes) |
|
Secondary |
Oral processing behaviour |
Participants will be video-recorded to measure oral processing behaviour of the test meal |
During test day 3 (up to 15 minutes) |
|
Secondary |
Blood lipids |
Plasma total cholesterol, triglycerides, LDL and HDL cholesterol, colourimetrically |
During test day 1 |
|
Secondary |
Blood lipids |
Plasma total cholesterol, triglycerides, LDL and HDL cholesterol, colourimetrically |
During test day 2 |
|
Secondary |
Blood lipids |
Plasma total cholesterol, triglycerides, LDL and HDL cholesterol, colourimetrically |
During test day 3 |
|
Secondary |
Glucose response |
Blood glucose response will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240 minutes) |
During test day 1 (up to 4 hours) |
|
Secondary |
Glucose response |
Blood glucose response will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240 minutes) |
During test day 2 (up to 4 hours) |
|
Secondary |
Glucose response |
Blood glucose response will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240 minutes) |
During test day 3 (up to 4 hours) |
|
Secondary |
Insulin response |
Blood C-peptide (as indicator of insulin response) will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240 minutes). |
During test day 1 (up to 4 hours) |
|
Secondary |
Insulin response |
Blood C-peptide (as indicator of insulin response) will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240 minutes). |
During test day 2 (up to 4 hours) |
|
Secondary |
Insulin response |
Blood C-peptide (as indicator of insulin response) will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240 minutes). |
During test day 3 (up to 4 hours) |
|
Secondary |
Incretin hormones |
Incretin hormones (GLP-1 and PYY) will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240 minutes). |
During test day 1 (up to 4 hours) |
|
Secondary |
Incretin hormones |
Incretin hormones (GLP-1 and PYY) will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240 minutes). |
During test day 2 (up to 4 hours) |
|
Secondary |
Incretin hormones |
Incretin hormones (GLP-1 and PYY) will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240 minutes). |
During test day 3 (up to 4 hours) |
|
Secondary |
Short-chain-fatty-acids |
Short-chain-fatty-acids will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, 480 minutes). |
During test day 1 (up to 8 hours) |
|
Secondary |
Short-chain-fatty-acids |
Short-chain-fatty-acids will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, 480 minutes). |
During test day 2 (up to 8 hours) |
|
Secondary |
Short-chain-fatty-acids |
Short-chain-fatty-acids will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, 480 minutes). |
During test day 3 (up to 8 hours) |
|
Secondary |
Short-chain-fatty-acids |
Faecal (GC-FID) |
1 time after intervention with each bread type (totally 3 times over a period of 10 weeks) |
|
Secondary |
Gastric emptying rate |
Gastric emptying rate will be measured through 13C-octanoic acid breath samples collected before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes). |
During test day 1 (up to 4 hours) |
|
Secondary |
Gastric emptying rate |
Gastric emptying rate will be measured through 13C-octanoic acid breath samples collected before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes). |
During test day 2 (up to 4 hours) |
|
Secondary |
Gastric emptying rate |
Gastric emptying rate will be measured through 13C-octanoic acid breath samples collected before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes). |
During test day 3 (up to 4 hours) |
|
Secondary |
Free-living energy intake |
4-day food diaries, mobile app |
4 days during intervention with each bread type (totally 3x4 days over a period of 10 weeks) |
|
Secondary |
Stool shape and consistency |
4-day stool diaries, the Bristol Stool Score |
4 days during intervention with each bread type (totally 3x4 days over a period of 10 weeks) |
|
Secondary |
Change in Gut microbiota composition |
Change in Gut microbiota composition after consumption of each test meal for 14 days will be analysed using the relative abundance of bacterial taxa according to 16S rRNA sequencing data |
1 time after intervention with each bread type (totally 3 times over a period of 10 weeks) |
|