Thies 2012.
| Study characteristics | ||
| Methods | RCT of the provision of fruit and vegetables to increase consumption | |
| Participants | Healthy men and women aged 40‐65 years were recruited from the surrounding community of Aberdeen. Two hundred and forty‐seven participants were recruited and randomised to three arms ‐ High tomato diet, Lycopene or the control group (low tomato diet). Exclusion criteria: diagnosed CVD, diabetes, fasting blood glucose of > 7.0 mmol/L, asthma, SBP > 160 mmHg and DBP > 99 mmHg, or a thyroid condition. Eighty‐four participants were randomised to receive the high tomato diet (age 51.0 ± 0.7) and eighty‐one participants were randomised to the control ( age 51.1 ± 0.7). The country of publication was the UK. |
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| Interventions | Provision group: provided with tomato‐based products (tomato sauces, juice, ketchup, soup, puree and canned tomatoes) for 12 weeks. Aside from these products participants selected their own foods to eat. Control group: Intake of tomato‐based products was restricted. Participants could not consume passata, canned tomatoes, cooked tomatoes, tomato paste, puree, pizza, salsa, chutney, canned beans, spaghetti, ravioli in tomato sauce, barbecue sauce, brown sauce, pink grapefruit, guava, watermelon and apricots. They could consume up to one portion of tomato soup, juice or sauce per week and either ≤ 4 raw tomatoes or 24 cherry tomatoes a week or ≤ one portion of tomato ketchup a week. The follow‐up period was 12 weeks. |
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| Outcomes | BP and lipids | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Method of randomisation was not given |
| Allocation concealment (selection bias) | Unclear risk | Information on the method of allocation concealment was not provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Single‐blind |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information was provided |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Number of drop‐outs given by group and reasonably well balanced across groups. |
| Selective reporting (reporting bias) | Low risk | Primary and secondary outcomes were clearly stated and reported |
| Other bias | Unclear risk | Insufficient information to judge |
BP: blood pressure CVD: cardiovascular disease DBP: diastolic blood pressure FV: fruit and vegetables g/d: grams per day HDL‐C: high‐density lipoprotein cholesterol RCT: randomised controlled trial SBP: systolic blood pressure SD: standard deviation TG: triglycerides