Condition category
Circulatory System
Date applied
10/05/2010
Date assigned
22/06/2010
Last edited
17/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Frank Thies

ORCID ID

Contact details

Polwarth Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
+44 (0)1224 553 020
f.thies@abdn.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Lycopene

Primary outcome measures

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

01/07/2007

Overall trial end date

31/08/2010

Reason abandoned

Eligibility

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

180

Participant 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

Recruitment start date

01/07/2007

Recruitment end date

31/08/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Polwarth Building
Aberdeen
AB25 2ZD
United Kingdom

Sponsor information

Organisation

University of Aberdeen (UK)

Sponsor details

Polwarth Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
f.thies@abdn.ac.uk

Sponsor type

University/education

Website

http://www.abdn.ac.uk

Funders

Funder type

Government

Funder name

Food Standards Agency (UK) (ref: NO2038)

Alternative name(s)

FSA

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22492370

Publication citations

  1. Results

    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.

Additional files

Editorial Notes