Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Changes in the faecal metabolites using targeted and untargeted metabolomics |
Difference in faecal metabolites depending on the protein supplementation amount. Targeted and untargeted metabolomics measurements will be used (e.g., short-chain fatty acids and branched chain fatty acids analyses, and polar and non polar metabolomics). Faecal samples will have their metabolites extracted and quantified by liquid chromatography coupled with high-resolution time-of-flight mass spectrometry (UHPLC-qToF-MS), and gas chromatography coupled with high-resolution mass spectroscopy (GC-Orbitrap). The level of metabolites will be compared throughout the whole study. |
8 weeks |
|
Primary |
Routinely analysed markers for protein intake/compliance - urine |
Difference in 24 h urine samples markers due to the protein supplementation (e.g., for 24 h urine: urea nitrogen from 24 h urine, creatinine, uric acid) |
5 weeks |
|
Primary |
Routinely analysed markers for protein intake/compliance - blood |
Difference in blood (serum) samples markers due to the protein supplementation (e.g., urea and creatinine) |
5 weeks |
|
Secondary |
Food intake using food diaries |
Food diaries 3 times a week |
8 weeks |
|
Secondary |
Changes in the gut microbiota profile during the baseline period |
Difference in the gut microbiota profile/composition during the baseline period will be assessed by 16s/NGS (next-generation sequencing). Alpha and Beta diversity will be measured and compared throughout these 4 weeks of baseline. |
4 weeks |
|
Secondary |
Changes in the faecal metabolites during the baseline period |
The difference in the metabolites profile during the baseline will be assessed by targeted and untargeted metabolomics. Targeted and untargeted metabolomics measurements will be used (e.g., short-chain fatty acids and branched chain fatty acids analyses and polar and non-polar metabolomics). Faecal samples will have their metabolites extracted and quantified by liquid chromatography coupled with high-resolution time-of-flight mass spectrometry (UHPLC-qToF-MS), and gas chromatography coupled with high-resolution mass spectroscopy (GC-Orbitrap). The level of metabolites will be compared during the baseline period. |
4 weeks |
|
Secondary |
Profile/composition of the gut microbiota during the intervention |
Difference in the gut microbiota profile/composition because of the protein supplementation will be assessed by 16s/NGS. Alpha and Beta diversity will be measured and compared throughout the 5 weeks of intervention. |
5 weeks |
|
Secondary |
Assessment of the Gastrointestinal Symptom rating scale (GSRS) during the study |
The gastrointestinal symptoms will be assessed during the baseline and protein supplementation period. Difference in the frequency and severity of gastrointestinal symptoms during the study will be assessed (15 questions with a scale of 1-7, minimum value 1, maximum 7, higher score correspond to a worse outcome) |
8 weeks |
|
Secondary |
Assessment of the bowel movement using the Bristol scale diary |
The bowel movement will be assessed during the baseline and protein supplementation period by the Bristol scale diary. In the diary they write down the type of stool based on the scale which shows 7 pictures of different forms of stool, from watery diarrhea to compact. Participants are asked to choose the form of stool they have every day during the study. |
8 weeks |
|
Secondary |
Assessment of physical activity level |
To assess the maintenance or difference of physical activity level during the baseline and dietary intervention by the AKTIVITETSVANOR questionnaire (Swedish questionnaire to assess physical activity frequency for 7 days). |
8 weeks |
|
Secondary |
Assessment of height |
The height will be assessed in meters. |
5 weeks |
|
Secondary |
Assessment of body composition |
Participants will be have their body composition measured using Tanita® full body scale. For this their height (m) will be measured and the information will be entered at the Tanita® scale. The obtained results by Tanita are: weight (kg), muscle mass (% and kg), body water content (% and kg), fat mass (% and kg), basal energy expenditure (kcal and kJ) and BMI in kg/m^2. |
6 weeks |
|
Secondary |
Assessment of body weight during the study |
Participants will be weighted in order to have information of their body weight changes in kilograms during the study. |
6 weeks |
|
Secondary |
Concentrations of faecal calprotectin |
Difference in faecal levels of calprotectin during the study intervention |
5 weeks |
|
Secondary |
Concentration of glucose |
Measurement of glucose in blood samples |
5 weeks |
|
Secondary |
Concentration of insulin |
Measurement of insulin in blood samples |
5 weeks |
|
Secondary |
Concentration of C-reactive protein |
Measurement of C-reactive protein in blood samples |
5 weeks |
|
Secondary |
Concentration of cholesterol (total, LDL, and HDL) |
Measurement of cholesterol (total, LDL, and HDL) in blood samples |
5 weeks |
|
Secondary |
Concentration of triglycerides |
Measurement of triglycerides in blood samples |
5 weeks |
|