Dr Frank Thies
+44 (0)1224 553 020
Effect of a tomato-rich diet on markers of cardiovascular risk in middle aged people: a single centre randomised controlled intervention study
10 mg daily lycopene consumption from a high tomato diet or lycopene supplementation can reduce markers for cardiovascular risk in middle aged people.
North of Scotland Research Ethics Committees approved on the 23rd May 2007 (ref: 07/S801/32)
Single centre single blind randomised controlled longitudinal intervention study
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Cardiovascular disease risk markers
The dietary interventions proposed for this project are designed to compare three diets, each of which are practical and realistic for individuals to achieve. Each dietary intervention will be of 12 weeks duration.
1. Control group (diet limited in tomato-based foods):
The control group will be free to eat normally, but their intake of tomato-based foods will be restricted. They will not be allowed to consume any of the forbidden foods* listed below, but will be allowed to consume up to 1 portion of tomato soup, tomato juice or tomato sauce per week, and either:
1.1. Up to 4 raw tomatoes/24 cherry tomatoes per week, or
1.2. Up to 1 portion of tomato ketchup per week
2. Tomato group (diet rich in tomato-based foods):
The tomato group will be asked to consume a minimum of 70 mg lycopene per week from tomato-based foods which will be provided, including tomato juice, tomato ketchup, tomato sauce or tomato soup. Guidance will be provided on the number of portions needed to reach the required amount of lycopene intake using a points system. In addition, recipe suggestions can be provided for use of the tomato sauce, e.g. with pasta, with chicken and rice, with vegetables, in a bolognese sauce etc. The consumption of lycopene-equivalent tomato-based food should however not exceed 100 mg per week.
This group will not be allowed to consume any of the forbidden foods*, but will be allowed to consume, in addition to the soups/juices/sauces/ketchup, up to 4 raw tomatoes/24 cherry tomatoes per week.
3. Lycopene group (diet limited in tomato-based foods but supplemented with lycopene capsules):
The lycopene group will be free to eat normally, with the exception of consumption of forbidden foods, but will be supplemented with lycopene capsules (10 mg per day) to match the lycopene intake of the group consuming the tomato-rich foods.
Passata, canned tomatoes, cooked tomatoes (fried, grilled, etc.), tomato paste, tomato puree, pizza, salsa, chutney, canned beans/spaghetti/ravioli, etc., in tomato sauce, barbeque sauce, brown sauce, pink grapefruit, guava, watermelon, or apricots.
Primary outcome measure
Serum total and low density lipoprotein (LDL) cholesterol and intercellular adhesion molecule 1 (ICAM-1) concentrations. All outcomes are measured four times during the study: prior run-in periods, at baseline (after run-in period), after 6 and 12 weeks intervention.
Secondary outcome measures
Insulin sensitivity as well as vascular function and inflammation markers (vascular tonicity by pulse-wave velocity, interleukin-6 [IL-6] and high sensitivity C-reactive protein [hsCRP]). All outcomes are measured four times during the study: prior run-in periods, at baseline (after run-in period), after 6 and 12 weeks intervention.
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Men and women aged 40 - 65 years
2. Body mass index (BMI) between 25 and 35 kg/m^2
3. Recruited from the surrounding community of Aberdeen
4. Sedentary or moderately active (less than two aerobic session per week)
5. Present signs of metabolic syndrome, e.g., if he/she has three or more of the following conditions:
5.1. Fasting plasma glucose (greater than 6.1 mm/L)
5.2. Triacylglycerol (TAG) level (greater than 1.7 mmol/L)
5.3. Low high density lipoprotein (HDL) cholesterol (less than 1.04 mmol/L for men, less than 1.29 mmol/L for women)
5.4. Hypertension (greater than 130/85 mmHg)
5.5. Central obesity (waist circumference greater than 102 cm for men, greater than 88 cm for women)
5.6. Moderate hypercholesterolaemia
Target number of participants
Participant exclusion criteria
1. Cardiovascular disease (CVD)
4. Systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 99 mmHg
5. Thyroid gland disorders or eating disorders
6. Regularly taking medication or supplements known to affect any dependant variable measured
7. High habitual intake of tomato-based food (greater than 5 servings per week)
8. Regularly taking nutritional supplements such as antioxidants or fish oil
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Food Standards Agency (UK) (ref: NO2038)
Funding Body Type
private sector organisation
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22492370
Thies F, Masson LF, Rudd A, Vaughan N, Tsang C, Brittenden J, Simpson WG, Duthie S, Horgan GW, Duthie G, Effect of a tomato-rich diet on markers of cardiovascular disease risk in moderately overweight, disease-free, middle-aged adults: a randomized controlled trial., Am. J. Clin. Nutr., 2012, 95, 5, 1013-1022, doi: 10.3945/ajcn.111.026286.