Effects of tomato-based foods on cardiovascular disease risk
| ISRCTN | ISRCTN34203810 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34203810 |
| Secondary identifying numbers | N/A |
- Submission date
- 10/05/2010
- Registration date
- 22/06/2010
- Last edited
- 19/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Frank Thies
Scientific
Scientific
Polwarth Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
| Phone | +44 (0)1224 553 020 |
|---|---|
| f.thies@abdn.ac.uk |
Study information
| Study design | Single centre single blind randomised controlled longitudinal intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effect of a tomato-rich diet on markers of cardiovascular risk in middle aged people: a single centre randomised controlled intervention study |
| Study acronym | LYCTOM trial |
| Study objectives | 10 mg daily lycopene consumption from a high tomato diet or lycopene supplementation can reduce markers for cardiovascular risk in middle aged people. |
| Ethics approval(s) | North of Scotland Research Ethics Committees approved on the 23rd May 2007 (ref: 07/S801/32) |
| Health condition(s) or problem(s) studied | Cardiovascular disease risk markers |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Lycopene |
| 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 study start date | 01/07/2007 |
| Completion date | 31/08/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 180 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2007 |
| Date of final enrolment | 31/08/2010 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Polwarth Building
Aberdeen
AB25 2ZD
United Kingdom
AB25 2ZD
United Kingdom
Sponsor information
University of Aberdeen (UK)
University/education
University/education
Polwarth Building
Foresterhill
Aberdeen
AB25 2ZD
Scotland
United Kingdom
| f.thies@abdn.ac.uk | |
| Website | http://www.abdn.ac.uk |
"ROR" |
https://ror.org/016476m91 |
Funders
Funder type
Government
Food Standards Agency (UK) (ref: NO2038)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- The Food Standards Agency, FSA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2012 | Yes | No | |
| Results article | 01/08/2022 | 19/08/2022 | Yes | No |
Editorial Notes
19/08/2022: Publication reference added.
