Kaats 1998.
| Methods | Parallel randomised controlled clinical trial | |
| Participants |
Inclusion criteria: adults consulting their personal physician Exclusion criteria: not stated Diagnostic criteria: not stated |
|
| Interventions |
Number of study centres: 1 Treatment before study: not stated Titration period: not stated |
|
| Outcomes | Outcomes reported in abstract of publication: body weight, percentage body fat, fat mass and fat‐free mass | |
| Study details |
Run‐in period: 90 days Study terminated before regular end: no |
|
| Publication details |
Language of publication: English Commercial funding: this study has been supported financially by Nutrition 21, Inc., San Diego, California Publication status: peer review journal |
|
| Stated aim for study | Quote: "To determining whether the body composition changes observed in the initial study could be replicated in this study" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: randomised, but method not stated |
| Allocation concealment (selection bias) | Low risk | Comment: independent local pharmacist |
| Blinding of participants and personnel (performance bias) Objective outcomes | Low risk | Quote: "None of the investigators, research technicians dispensing the product, or participants knew which participant's number corresponded to the placebo or active product. An independent local pharmacist acted as trustee for the study and randomly assigned participant's numbers to bottles that had been prelabeled with either an “X” or “Y” to correspond with either active product or placebo" |
| Blinding of participants and personnel (performance bias) Subjective outcomes | Low risk | Comment: no subjective outcomes |
| Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Comment: not details provided |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Low risk | Comment: no subjective outcomes |
| Incomplete outcome data (attrition bias) Objective outcomes | Low risk | Comment: no dropouts |
| Incomplete outcome data (attrition bias) Subjective outcomes | Low risk | Comment: no subjective outcomes |
| Selective reporting (reporting bias) | Low risk | Comment: all of the outcomes listed in the methods section were reported as results |
| Other bias | Unclear risk | Comment: the trial had a commercial source of funding possibly creating a risk of bias |