Yazaki 2010.
| Methods | Parallel randomised controlled clinical trial | |
| Participants |
Inclusion criteria: overweight (BMI > 25 kg/m2) non‐smoking adults aged 25 to 75 years with abdominal adiposity (waist circumference > 80 cm in females and > 100 cm in males) Exclusion criteria: contraindication to abdominal computed tomography scans (weight > 375 pounds, claustrophobia, unstable vital signs, or radiation procedure in past six months), diagnosed diabetes, diagnosed eating disorder, uncontrolled hypertension, emphysema, intestinal or stomach disease, kidney disease, substance abuse, pregnancy or intention to become pregnant during the study Diagnostic criteria: BMI, waist circumference measures |
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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: weight, height, blood pressure, percentage body fat, serum and urinary biomarkers | |
| Study details |
Run‐in period: 24 weeks Study terminated before regular end: no |
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| Publication details |
Language of publication: English Commercial funding: supported by Nutrition 21, Inc Publication status: peer review journal |
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| Stated aim for study | Quote: "Assess the effects of chromium picolinate supplementation, alone and combined with nutritional education, on weight loss in healthy overweight adults" | |
| Notes | Abbreviations: BMI: body mass index | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "People were enrolled and randomized using balanced allocation within gender" Comment: no details provided |
| Allocation concealment (selection bias) | Low risk | Quote: "People and study personnel were blinded to the intervention. Chromium and placebo were prepackaged and shipped from the manufacturer to the study site. Bottles were labelled and coded by an unblinded individual unaffiliated with the study. Investigators thus only knew the treatment assignment (group A or B) of the people without knowledge of whether these contained chromium or placebo" |
| Blinding of participants and personnel (performance bias) Objective outcomes | Low risk | Quote: "People and study personnel were blinded to the intervention. Chromium and placebo were prepackaged and shipped from the manufacturer to the study site. Bottles were labelled and coded by an unblinded individual unaffiliated with the study. Investigators thus only knew the treatment assignment (group A or B) of the people without knowledge of whether these contained chromium 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: no details provided |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Low risk | Comment: no subjective outcomes |
| Incomplete outcome data (attrition bias) Objective outcomes | Unclear risk | Comment: insufficient reporting of attrition/exclusions to permit judgement |
| Incomplete outcome data (attrition bias) Subjective outcomes | Low risk | Comment: no subjective outcomes |
| Selective reporting (reporting bias) | Low risk | Comment: the study protocol is not available |
| Other bias | Unclear risk | Comment: the trial had a commercial source of funding possibly creating a risk of bias |