Kaats 1996.
| Methods | Parallel randomised controlled clinical trial | |
| Participants |
Inclusion criteria: adults consulting their personal physician Exclusion criteria: not stated Diagnostic criteria: not stated |
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| Interventions |
Number of study centres: 1 Treatment before study: not stated Titration period: not stated |
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| Outcomes | Outcomes reported in abstract of publication: body composition, body weight, percentage body fat, non‐fat mass and body composition improvement | |
| Study details |
Run‐in period: 72 days Study terminated before regular end: not stated |
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| Publication details |
Language of publication: English Commercial funding: "Funding for the study was provided by the Living at Goal Weight Center, San Antonio, Texas; Optimal Health Products, San Antonio, Texas; and Nutrition 21, Inc., San Diego, California." Publication status: peer review journal |
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| Stated aim for study | Quote: "To examine the effect of chromium picolinate (CrP) on body composition" | |
| 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) | Unclear risk | Comment: not reported |
| Blinding of participants and personnel (performance bias) Objective outcomes | Low risk | Comment: none of the investigators, research technicians dispensing the product or populations knew which code corresponded to the amount of CrP in the canister |
| 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 | Unclear risk | Comment: no subjective outcomes |
| Incomplete outcome data (attrition bias) Objective outcomes | Unclear risk | Quote: "Some concerns may be raised about the relatively high dropout rate in our study ‐ 69 of 219 (31.5%). A comparison of their initial body composition scores revealed no significant difference between the three groups nor between any of the three groups of patients who completed or failed to complete the protocol" Comment: unclear influence of attrition rate |
| Incomplete outcome data (attrition bias) Subjective outcomes | Low risk | Comment. no subjective outcome |
| 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 |