Campbell 1999.
| Methods | Parallel randomised controlled clinical trial | |
| Participants |
Inclusion criteria: men, age range 50 to 75 years; BMI range 27 to 34 kg/m2; non‐diabetic; physically able to safely engage in all aspects of the study protocol; clinically normal cardiac function, blood pressure, liver function and kidney function 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 weight, each man’s baseline maximal strength for each exercise was set as the greater of two one‐repetition‐maximum values obtained during the first two resistance exercise sessions; urinary creatinine excretion (P < 0.001), muscle strength (P < 0.001), arm‐pull muscle power, knee‐extension muscle power, fat‐free mass (P < 0.001), whole body muscle mass (P < 0.001) and vastus lateralis type II fibre area (P < 0.05) | |
| Study details |
Run‐in period: 13 weeks Study terminated before regular end: no |
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| Publication details |
Language of publication: English Commercial / non‐commercial / other funding: supported by National Institute on Aging Grants T32 AG‐0048, 1‐R29‐AG‐13409 and RO1‐AG‐11811, by General Clinical Research Center Grant MO1‐RR‐10732, and by an independent monetary gift from Nutrition 21 Publication status: peer review journal |
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| Stated aim for study | Quote: "To assess the effect of high‐dose chromium picolinate supplementation on body composition, including body density, whole body muscle mass and muscle" | |
| Notes | Abbreviations: BMI: body mass index; Cr: creatinine | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Each man was randomly assigned in a double‐blind fashion to either a chromium picolinate group or a placebo group" Comment: no detail is given on the methodology |
| Allocation concealment (selection bias) | Unclear risk | Comment: no details provided |
| Blinding of participants and personnel (performance bias) Objective outcomes | Unclear risk | Comment: no details provided |
| Blinding of participants and personnel (performance bias) Subjective outcomes | Unclear risk | Comment: no details provided |
| Blinding of outcome assessment (detection bias) Objective outcomes | Unclear risk | Comment: no details provided |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | Comment: no details provided |
| Incomplete outcome data (attrition bias) Objective outcomes | Low risk | Eighteen of 23 men successfully completed the study protocol. The reasons for the five men withdrawing included the following: 1) a request by a participant’s personal physician to avoid aggravation of a chronic hip injury; 2) an irritation of chronic elbow tendonitis, unrelated to resistance exercise; 3) a personal family commitment; 4) a resistance exercise‐induced aggravation of an existing knee condition; and 5) a shoulder injury caused by slipping on ice. Comment: The primary outcome data were all reported |
| Incomplete outcome data (attrition bias) Subjective outcomes | Unclear risk | Comment: no details provided |
| Selective reporting (reporting bias) | Low risk | Comment: the study protocol is not available Comment: nothing was detected |
| Other bias | Unclear risk | Comment: the trial had a commercial source of funding possibly creating a risk of bias |