Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Difference in glucose regulation between the control and intervention arm |
Difference in 0 minutes glucose on 75g oral glucose tolerance test between the control arm and the intervention arm. |
6 weeks |
|
Secondary |
120 minutes glucose on 75g oral glucose tolerance test |
Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks. |
6, 12 and 26 weeks |
|
Secondary |
0 minutes glucose on 75g oral glucose tolerance test |
Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks. |
6, 12 and 26 weeks |
|
Secondary |
Concentration of glycated haemoglobin in blood |
Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 12 and 26 weeks. |
12 and 26 weeks |
|
Secondary |
Weight |
Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks. |
6, 12 and 26 weeks |
|
Secondary |
BMI |
Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks. |
6, 12 and 26 weeks |
|
Secondary |
Lean mass |
Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks. |
6, 12 and 26 weeks |
|
Secondary |
Fat mass |
Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks. |
6, 12 and 26 weeks |
|
Secondary |
Waist circumference |
Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks. |
6, 12 and 26 weeks |
|
Secondary |
Measurement of total cholesterol in blood |
Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks. |
6, 12 and 26 weeks |
|
Secondary |
Measurement of fasting triglycerides in blood |
Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks. |
6, 12 and 26 weeks |
|
Secondary |
Measurement of LDL cholesterol in blood |
Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks. |
6, 12 and 26 weeks |
|
Secondary |
Measurement of HDL cholesterol in blood |
Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks. |
6, 12 and 26 weeks |
|
Secondary |
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) |
Derived from measurements of insulin and glucose in blood. Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks. |
6, 12 and 26 weeks |
|
Secondary |
Measurement of 120 minute c-peptide |
Measured after a 75g oral glucose tolerance test. Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks. |
6, 12 and 26 weeks |
|
Secondary |
Systolic blood pressure |
Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks. |
6, 12 and 26 weeks |
|
Secondary |
Diastolic blood pressure |
Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks. |
6,12 and 26 weeks |
|
Secondary |
Dietary intake |
Dietary intake will be assessed using 24-hours recall questionnaire (food frequency questionnaire [FFQ]) at visits 4, 5, 7, 9 and 11. Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks. |
6,12 and 26 weeks |
|
Secondary |
Energy intake from a food frequency questionnaire |
Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks. |
6,12 and 26 weeks |
|
Secondary |
Carbohydrate intake from a food frequency questionnaire |
Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks. |
6, 12 and 26 weeks |
|
Secondary |
Fat intake from a food frequency questionnaire |
Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks. |
6, 12 and 26 weeks |
|
Secondary |
Saturated fat intake from a food frequency questionnaire |
Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks. |
6, 12 and 26 weeks |
|
Secondary |
Salt intake from a food frequency questionnaire |
Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks. |
6,12 and 26 weeks |
|
Secondary |
Concentration of Vitamin D in blood |
Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks. |
6, 12 and 26 weeks |
|
Secondary |
Concentration of Vitamin B6 in blood |
Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks. |
6, 12 and 26 weeks |
|
Secondary |
Vitamin B12 from a food frequency questionnaire |
Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks. |
6, 12 and 26 weeks |
|
Secondary |
Number of participant withdrawals in the trial |
Number of participant withdrawals in the trial |
26 weeks |
|