Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Total volumetric bone mineral density of the distal tibia |
Percentage change in total volumetric bone density measured using high resolution peripheral quantitative computed tomography (HR-pQCT) of the distal tibia. |
12 months |
|
Secondary |
Bone mineral density of the lumbar spine |
Relative change in lumbar spine (L1-L4) bone mineral density (BMD) measured using dual energy X-ray absorptiometry (DXA) |
12 months |
|
Secondary |
Bone mineral density of the hip |
Relative change in total hip BMD measured using DXA |
12 months |
|
Secondary |
Tibia and radius trabecular bone volume |
Relative change in tibia and radius trabecular bone volume fraction measured using HR-pQCT |
12 months |
|
Secondary |
Tibia and radius cortical area |
Relative change in tibia and radius cortical area measured using HR-pQCT |
12 months |
|
Secondary |
Tibia and radius cortical volumetric bone mineral density |
Relative change in tibia and radius cortical volumetric BMD measured using HR-pQCT |
12 months |
|
Secondary |
Total volumetric bone mineral density of the distal radius |
Relative change in total volumetric BMD of the distal radius measured using HRpQCT |
12 months |
|
Secondary |
Serum C-terminal cross-linking telopeptide of type I collagen (ßCTX-I) - bone turnover marker |
Relative change in ßCTX-I in serum |
6 months and 12 months |
|
Secondary |
Serum procollagen type 1 N-terminal propeptide (P1NP) - bone turnover marker |
Relative change in P1NP levels in serum |
6 months and 12 months |
|
Secondary |
Serum osteocalcin (OC) - bone turnover marker |
Relative change in OC in serum |
6 months and 12 months |
|
Secondary |
Short-chain fatty acids (SCFAs) |
Relative change in SCFA levels (including butyrate) in stool |
6 months, 12 months, and 2 weeks post intervention |
|
Secondary |
16s rRNA genetic sequencing of the gut microbiota |
Relative change in species-level gut microbiota composition in stool using 16s rRNA sequencing |
6 months, 12 months, and 2 weeks post intervention |
|
Secondary |
Fasting blood glucose |
Relative change in fasted blood glucose levels in circulating blood |
6 months and 12 months |
|
Secondary |
Glycated haemoglobin (HbA1c) |
Relative change in HbA1c levels in circulating blood |
6 months and 12 months |
|
Secondary |
Lower leg muscle area |
Relative change in lower leg muscle area measured using HR-pQCT |
12 months |
|
Secondary |
Lean body mass |
Relative change in appendicular lean body mass measured using DXA |
12 months |
|
Secondary |
Grip strength |
Relative change in left and right hand grip strength measured using a hand dynamometer |
6 months and 12 months |
|
Secondary |
High-sensitivity C-reactive protein (hs-CRP) |
Relative change in hs-CRP levels in serum |
6 months and 12 months |
|
Secondary |
Regulatory T lymphocytes (Tregs) |
Relative change in circulating number of Tregs in blood |
12 months |
|
Secondary |
Oral glucose tolerance test (OGTT) |
Relative change in oral glucose tolerance in circulating blood |
6 months and 12 months |
|
Secondary |
Muscle tissue glycogen content |
Relative change in muscle tissue glycogen content obtained from a muscle biopsy |
6 months and 12 months |
|
Secondary |
Muscle tissue triglyceride content |
Relative change in muscle tissue triglyceride content obtained from a muscle biopsy |
6 months and 12 months |
|
Secondary |
Muscle tissue type 1 fibre composition |
Relative change in muscle tissue type 1 fibre proportion obtained from a muscle biopsy |
6 months and 12 months |
|
Secondary |
Lipocalin2 |
Relative change in Lipocalin2 (intestinal inflammation) in stool |
6 months, 12 months, and 2 weeks post intervention |
|
Secondary |
Cogstate One back Test Cognitive performance test |
Relative change in speed of performance and number of errors in the One Back Test using the Cogstate cognitive assessment tool. Lower score = better performance |
6 months and 12 months |
|
Secondary |
Cogstate Groton Maze Learning Test Cognitive performance test |
Relative change in number of errors in the Groton Maze Learning Test using the Cogstate cognitive assessment tool. Lower score = better performance |
6 months and 12 months |
|
Secondary |
Cogstate Continuous Paired Associate Learning Test Cognitive performance test |
Relative change in accuracy of performance and number of errors in the Continuous Paired Associate Learning Test using the Cogstate cognitive assessment tool. Lower score = better performance |
6 months and 12 months |
|
Secondary |
Cogstate Social Emotional Cognition Test Cognitive performance test |
Relative change in accuracy of performance in the Social Emotional Cognition Test using the Cogstate cognitive assessment tool. Higher score = better performance |
6 months and 12 months |
|
Secondary |
Depression, Anxiety and Stress Scale 21 |
Relative change in depression, anxiety and stress measured using the Depression Anxiety and Stress Scale 21 (DASS-21) questionnaire. The DASS-21 has a minimum score of 0 and a maximum score of 63 with higher scores indicating a worse outcome. |
6 months and 12 months |
|
Secondary |
Gastrointestinal Symptom Rating Scale |
Relative change in gastrointestinal symptoms measured using the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire. The GSRS has a minimum score of 5 and a maximum score of 45 with higher scores indicating a worse outcome. |
6 months and 12 months |
|
Secondary |
Plasma glucagon-like peptide 1 |
Relative change in gut hormone glucagon-like peptide 1 [GLP-1] in plasma |
6 months and 12 months |
|
Secondary |
Plasma peptide tyrosine-tyrosine |
Relative change in gut hormone peptide tyrosine-tyrosine [PYY] in plasma |
6 months and 12 months |
|
Secondary |
Plasma adiponectin |
Relative change adiponectin in plasma |
6 months and 12 months |
|
Secondary |
EuroQol Five Dimensions Quality of life Medical Outcome Survey |
Relative change in quality of life measured using the EuroQol Five Dimensions (EQ-5D) questionnaire. The EQ-5D has a minimum score of Level 1 and a maximum score of Level 5 with higher levels indicating a worse outcome |
6 months and 12 months |
|
Secondary |
Social Interaction Anxiety Scale |
Relative change in social anxiety measured using the Social Interaction Anxiety Scale (SIAS) questionnaire. The SIAS has a minimum score of 0 and a maximum score of 80 with higher scores indicating a worse outcome. |
6 months and 12 months |
|
Secondary |
The Warwick-Edinburgh Mental Wellbeing Scale |
Relative change in mental wellbeing measured using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) questionnaire. The WEMWBS has a minimum score of 14 and a maximum score of 70 with higher scores indicating a better outcome. |
6 months and 12 months |
|
Secondary |
Continuous blood glucose level monitoring for 10 days |
Relative change in blood glucose (area under the curve) over 10 days measured using a continuous glucose monitoring device |
6 months and 12 months |
|
Secondary |
Fasting blood insulin |
Relative change in fasted blood insulin levels in circulating blood |
6 months and 12 months |
|
Secondary |
Fat mass |
Relative change in total body fat mass measured using DXA |
12 months |
|
Secondary |
Blood metabolomics |
Relative change in blood metabolites using liquid chromatography-mass spectrometry |
12 months |
|
Secondary |
Office blood pressure |
Relative change in Systolic and Diastolic blood pressure measured using a sphygmomanometer |
6 months and 12 months |
|
Secondary |
The Visual Analogue Scale Pain Intensity |
Relative change in current pain intensity measured using a visual analogue scale (VAS) pain intensity scale. The VAS has a minimum score of 0 and a maximum score of 10 with higher scores indicating a worse outcome. |
6 months and 12 months |
|
Secondary |
Calprotectin |
Relative change in calprotectin (intestinal inflammation) in stool |
6 months, 12 months, and 2 weeks post intervention |
|
Secondary |
Muscle mass |
Relative change in total body muscle mass measured using DXA |
12 months |
|