Table 5.
Secondary and other outcomes investigated in substudies and in subgroups
| Outcome | Measurements and method | Participants | Time points of data collection | |||
| Baseline | After WL | After WM | ||||
| Month 0 CID1 |
Month 2 CID2 |
Month 6 CID3 |
Month 12 CID4 |
|||
| Substudies (include an intervention) | ||||||
| Brain reward activity | Brain activity is measured by fMRI after consumption of a drink with sugar, S&SEs, water | Substudy including a subgroup of adults in Maastricht | A | A | A | |
| Postprandial responses (energy expenditure, substrate oxidation, blood biochemistry and appetite) | Indirect calorimetry, blood sampling, appetite sensation based on VAS and ad libitum energy intake after consumption of a drink with S&SE or water | Substudy including a subgroup of adults in Copenhagen | A | A | A | |
| Subgroups | ||||||
| Physical activity | 7-day measurements by accelerometer | Adults in Maastricht | A | A | A | |
| Gut-brain signalling markers | Analyses of GLP-1, CCK and ghrelin from fasting blood samples | Adults in Copenhagen and Maastricht | A | A | A | A |
| Liver fat | 1H-MRS | Subgroup of adults in Maastricht | A | A | A | |
| Adipose tissue function and lipid metabolism | Adipocyte morphology, ex vivo lipolysis, gene and protein expression analyses of adipose tissue samples (biopsy) | Adults in Maastricht | A | A | A | |
| Insulin sensitivity markers | Indices for example, HOMA-IR, Matsuda index, Disposition index etc. calculated from a 7-point OGTT | Adults in Maastricht | A | A | A | |
| Gut microbiota | 16S rRNA illumine sequencing of faecal samples | Children in Maastricht | C | C | C | |
| Composition and functionality of the human gut microbiota in vitro | Microbial metabolites, for example, SCFA and 16S rRNA illumine sequencing of faecal samples | Subgroup of adults in Maastricht | A | |||
1H-MRS, Proton Magnetic Resonance Spectroscopy; A, adults; C, children; CCK, cholecystokinin; CID, clinical investigation day; fMRI, functional MRI; GLP-1, glucagon-like peptide 1; HOMA-IR, Homeostatic Model Assessment for Insulin Resistance; OGTT, oral glucose tolerance test; SCFA, short chain fatty acids; S&SEs, sweeteners and sweetness enhancers; VAS, visual analogue scales; WL, weight loss; WM, weight maintenance.