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. 2012 Dec 12;2012(12):CD008650. doi: 10.1002/14651858.CD008650.pub2

Suzuki 2009.

Methods This study was a randomised double‐blind, placebo‐controlled trial with a parallel design with a treatment to control randomisation ratio of 1:1.05
Participants INCLUSION CRITERIA:
  • BMI 23 to 30 kg/m2

  • total cholesterol 200 to 260 mg/dL OR LDL‐cholesterol ≥ 120 mg/dL


EXCLUSION CRITERIA:
  • receiving medical treatment for obesity or lifestyle illness (hyperlipidaemia, diabetes, hypertension)

  • regularly taking foods meant to aid weight loss or to improve serum lipid levels (including health foods targeting specific conditions)

  • taking over‐the‐counter drugs

  • history of food allergies

  • serious liver, kidney, heart, pulmonary, endocrine or metabolic disorder

  • participating simultaneously in another clinical trial

  • gave more than 200 mL of blood in last month OR more than 400 mL of blood in last 3 months

  • pregnant or may become pregnant or nursing


DIAGNOSTIC CRITERIA:
  • height

  • weight

  • BMI (calculated from previous 2 measurements)

  • small dense LDL cholesterol levels (measured using Seiken assay (Denka Seiken Co., Ltd.)

Interventions NUMBER OF STUDY CENTRES: NR
COUNTRY/ LOCATION: Japan
SETTING: NR
TREATMENT BEFORE STUDY:
note: 2‐week observation period
Outcomes OUTCOME(S) (as stated in the protocol/registered trial documents):
PRIMARY OUTCOME(S): unknown
SECONDARY OUTCOME(S): unknown
OTHER OUTCOME(S): unknown
Study details STUDY TERMINATED BEFORE REGULAR END: no
Publication details This study was published in Japanese in the journal Japanese Pharmacology and Therapeutics and no sources of support were declared by the study authors
Stated aim of study Quote from study: "our aim in this study was to measure visceral fat area in women of all ages and, with full regard for safety, establish whether there is an effect reducing body fat in women"
Notes BMI: body mass index; LDL: low density lipoprotein; NR: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote from study: "this study was conducted as a placebo‐controlled randomised double‐blind trial run in parallel groups for comparison purposes"
Comment: method of randomisation not reported
Allocation concealment (selection bias) Low risk Quote from study: "a third party not directly involved in the study [StatCom Co. Ltd (Tokyo; President: Hirokuni Amari)] randomly divided qualifying participants into two groups"
Comment: method of allocation concealment not reported; however, due to the use of a third party company to allocate participants into 2 groups, we judged there to be a low risk of bias
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote from study: "this study was conducted as a placebo‐controlled randomised double‐blind trial run in parallel groups for comparison purposes"
"IRB [review committee] verified prior to implementation of the study that there was no discernible difference between test beverages in appearance, taste or container (steel cans)."
Comment: No mention of effectiveness of blinding efforts. No mention of whether researchers and staff were blinded to study components.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote from study:
Comment: all outcomes on which the study reported were objective and measured by assessors. Therefore, whether or not assessors were blinded, risk of detection bias was assessed as low
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: authors adequately accounted for attrition
Selective reporting (reporting bias) Low risk Comment: all outcome measurements stated in methods section were reported in the results
Other bias Unclear risk Comment: 3 authors are affiliated with Soiken, Inc. and participants had previously registered as volunteers with Soiken, Inc; nature of corporate support for study is unclear