| Methods |
Trial design:
RCT
Randomisation procedure: Assigned by minimisation to 2 groups
Allocation concealment:
Not stated
Blinding:
Unclear
Intention to treat analysis:
Yes |
| Participants |
Country:
South Africa
Setting:
Community
Number:
32
Age:
35 +/‐ 6 years
Sex:
Female
Other characteristics:
Obese, hyperinsulinaemic compared to healthy females |
| Interventions |
Trial intervention:
Low insulin response, energy‐restricted diet (low glycaemic index)
Comparison:
Normal diet.
12 week crossover study with 12 week washout in between (stage 1 parallel study also reported) |
| Outcomes |
Main outcome measures:
Weight loss and plasma insulin concentrations
Other outcome measures:
Body mass index, plasma glucose, C‐peptide and insulin |
| Notes |
Source of funding:
Supported by Central Research Fund of the University of the Orange Free State |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
