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Effects of tomato-based foods on cardiovascular disease risk
ISRCTN ISRCTN34203810
DOI 10.1186/ISRCTN34203810
ClinicalTrials.gov identifier
EudraCT number
Public title Effects of tomato-based foods on cardiovascular disease risk
Scientific title Effect of a tomato-rich diet on markers of cardiovascular risk in middle aged people: a single centre randomised controlled intervention study
Acronym LYCTOM trial
Serial number at source N/A
Study hypothesis 10 mg daily lycopene consumption from a high tomato diet or lycopene supplementation can reduce markers for cardiovascular risk in middle aged people.
Lay summary Not provided at time of registration
Ethics approval North of Scotland Research Ethics Committees approved on the 23rd May 2007 (ref: 07/S801/32)
Study design Single centre single blind randomised controlled longitudinal intervention study
Countries of recruitment United Kingdom
Disease/condition/study domain Cardiovascular disease risk markers
Participants - 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
Participants - exclusion criteria 1. Cardiovascular disease (CVD)
2. Diabetes
3. Asthma
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
Anticipated start date 01/07/2007
Anticipated end date 31/08/2010
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 180
Interventions 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.

*Forbidden 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(s) 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 measure(s) 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.
Sources of funding Food Standards Agency (UK) (ref: NO2038)
Trial website
Publications 1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22492370
Contact name Dr  Frank  Thies
  Address Polwarth Building
Foresterhill
  City/town Aberdeen
  Zip/Postcode AB25 2ZD
  Country United Kingdom
  Tel +44 (0)1224 553 020
  Fax +44 (0)1224 554 761
  Email f.thies@abdn.ac.uk
Sponsor University of Aberdeen (UK)
  Address Polwarth Building
Foresterhill
  City/town Aberdeen
  Zip/Postcode AB25 2ZD
  Country United Kingdom
  Email f.thies@abdn.ac.uk
  Sponsor website: http://www.abdn.ac.uk
Date applied 10/05/2010
Last edited 17/04/2012
Date ISRCTN assigned 22/06/2010
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