Mackey 2000.
| Methods | Parallel randomised controlled clinical trial, randomisation ratio not reported | |
| Participants |
Inclusion criteria: postmenopausal women aged 45‐65 years Exclusion criteria: a history of allergy to soy or if any of them were taking cholesterol‐lowing agents Diagnostic criteria: a fasting TC > 5.5 mmol/L |
|
| Interventions |
Number of study centres: 1 Treatment before study: no Titration period: 12 wks |
|
| Outcomes | Outcomes reported in abstract of publication: TC, LDL‐C, HDL‐C, SHBG and LH | |
| Study details |
Run‐in period: yes Study terminated before regular end (for benefit/because of adverse events): no |
|
| Publication details |
Language of publication: English Commercial funding: yes Publication status: peer‐reviewed journal |
|
| Stated aim of study | Quote from publication: "We performed a series of studies in men and women using soy protein with or without isoflavones to study the effect on the lipoprotein profile as well as other biochemical indices such as sex hormones, pituitary hormones, markers of bone turnover and glucose tolerance" | |
| Notes | The female study was a prospective, double‐blind, randomised controlled study. The male study was an open prospective observational pilot study. Thus, only female study was included. The concentrations of LDL‐C maybe calculated Abbreviations: HDL: high‐density‐lipoprotein; LDL: low‐density‐lipoprotein |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote from publication: "Fifty four female subjects were randomised to receive 28 g of protein powder; either a) a soy protein with an isoflavone content of 65 mg isoflavones daily (ISP+) or b) a soy protein isolate with less than 4 mg isoflavones per daily (ISP‐)" Comment: no information about sequence generation |
| Allocation concealment (selection bias) | Unclear risk | Comment: no information about concealment |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote from publication: "The female study was a prospective, double‐blind, randomised controlled study" |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: no information about blinding |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "Of the 54 women who were randomised into the study, 49 women completed the study" Comment: number of participants analyzed was less than number of participants randomized |
| Selective reporting (reporting bias) | Low risk | Comment: none detected |
| Other bias | Low risk | Comment: no other sources of bias were found in this study |