Appendix 2: Examples of table layout for showing study characteristics An example of a summary table of study characteristics Study Study design Study objectives Sample Characteristics of Method to Confounders Method used to Study results1 Adverse effects reference size & participants measure food measured measure health (including effect size noted loss to consumption effect and statistical follow significance) up Zones RCT, Increase N=85 US white males Diet measured Changes in Plasma lipids No relationship Weight gain in et al unblended, consumption of 19-69 years, 62 with 2x4day antioxidant (HDL-, LDL- identified between some participant 2000 primary fruits and US white females diet records intake. consumption of when food and prevention vegetables to 7 aged 18-63 (wk 0 and 4) Decreased total an extra 4 serves vegetable were experimental serves/day will years. &1x24 hr recall and saturated fat Comments: of fruit and to existing trial. result in beneficial (wk6). intake and Outcome vegetables per food changes in plasma Inclusion: increased measured day for 8 weeks, consumption. Comments: lipid concentration. Eat<=3 serves Comments: carbohydrate with and serum (mean gain – Further detail fruit & vegetable Needed intake. Body appropriate and 1kg) required on per day additional diet mass increase methods in levels randomisation cholesterol measurement within energy experienced in healthy, technique <6mmol/L at end of intake not lab with adult study. controlled. established males and Exclusion: Did not fully QC females. Use of lipid define what Comments: no procedures. lowering was included adjustment for No statistical medication as fruit and confounders significant BMI>30 vegetable, e.g. undertaken. relationships inclusion of found (p>0.05) for Duration: 8 week processed all outcomes). test, plus 2 week varieties. run-in Bioavailability Comments: not relevant. Statistical adequate, but longer duration would have assisted study weight.
Appendix 2: Examples of table layout for showing study characteristics An example of a summary table of study characteristics Study reference Study design Study objectives Sample size & loss to follow up Characteristics of participants Method to measure food consumption Confounders measured Method used to measure health effect Study results1 (including effect size and statistical significance) Adverse effects noted Zones et al 2000 RCT, unblended, primary prevention experimental trial. Comments: Further detail required on randomisation technique Increase consumption of fruits and vegetables to 7 serves/day will result in beneficial changes in plasma lipid concentration. N=85 US white males 19-69 years, 62 US white females aged 18-63 years. Inclusion: Eat<=3 serves fruit & vegetable per day cholesterol <6mmol/L Exclusion: Use of lipid lowering medication BMI>30 Duration: 8 week test, plus 2 week run-in Comments: Statistical adequate, but longer duration would have assisted study weight. Diet measured with 2x4day diet records (wk 0 and 4) &1x24 hr recall (wk6). Comments: Needed additional diet measurement at end of study. Did not fully define what was included as fruit and vegetable, e.g. inclusion of processed varieties. Bioavailability not relevant. Changes in antioxidant intake. Decreased total and saturated fat intake and increased carbohydrate intake. Body mass increase within energy intake not controlled. Comments: no adjustment for confounders undertaken. Plasma lipids (HDL-, Comments: Outcome measured with appropriate methods in experienced lab with established QC procedures. No relationship identified between consumption of an extra 4 serves of fruit and vegetables per day for 8 weeks, and serum LDL- and levels in healthy, adult males and females. No statistical significant relationships found (p>0.05) for all outcomes). Weight gain in some participant when food and vegetable were to existing food consumption. (mean gain – 1kg)
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