Effects of tomato-based foods on cardiovascular disease risk

Not Applicable

Completed

• Conditions: Cardiovascular disease risk markers; Circulatory System; Cardiovascular disease

• Registration Number: ISRCTN34203810
• Lead Sponsor: niversity of Aberdeen (UK)

Brief Summary

2012 Results article in http://www.ncbi.nlm.nih.gov/pubmed/22492370 results 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35978954/ (added 19/08/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-22
• Study Completion: 2010-08-31
• Last Update Posted: 29 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 180

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.