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11 February 2012
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| [ Print-friendly version ] |
| Effect of whole grain foods on cardiovascular risk |
| ISRCTN | ISRCTN27657880 |
| ClinicalTrials.gov identifier | |
| Public title | Effect of whole grain foods on cardiovascular risk |
| Scientific title | Comparison of effects of increased whole grain foods on markers of cardiovascular risk: a single centre, single blind, randomised controlled longitudinal study |
| Acronym | N/A |
| Serial number at source | NO2035 |
| Study hypothesis | Dietary supplementation with three servings per day of whole-grain food provided as a mixture of wheat and oats or only wheat can decrease cardiovascular risk markers in healthy middle aged people. |
| Lay summary | |
| Ethics approval | North of Scotland Research Ethics Committee approved on the 23rd November 2005 (ref: 04/S0801/66) |
| Study design | Single centre single blind randomised controlled longitudinal study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Overweight/moderately obese |
| Participants - inclusion criteria |
1. Men and women aged 40 - 65 years
2. Body mass index (BMI in kg/m^2) between 25 and 35 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 hypercholesterolemia |
| Participants - exclusion criteria |
1. Cardiovascular disease (CVD)
2. Diabetes or fasting blood glucose concentration greater than 7.0 mmol/L 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. Taking regular medication or supplements known to affect any dependant variable measured 7. Volunteers with high habitual intake of whole-grain foods (greater than 5 servings per week) 8. Taking regular nutritional supplements such as antioxidants or fish oil |
| Anticipated start date | 30/06/2005 |
| Anticipated end date | 30/06/2009 |
| 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 (60 per group) |
| Interventions |
The dietary interventions proposed for this project are designed to compare a diet based on refined cereal products with:
1. The substitution of 3 servings of refined cereals foods with 3 servings of whole wheat foods, and 2. The substitution of 3 servings of refined cereals foods with one servings of whole wheat foods and two of oats The interventions are designed to be practical and realistic for individuals to achieve. These interventions represent a significant increase in current average intakes of non-starch polysaccharides (NSP). It is estimated that the substitution with 3 servings of whole wheat foods will provide approximately 6.4 g of NSP per day, of which 2.6 will be soluble fibre, while the whole wheat plus oats intervention will provide approximately 5.3 g NSP per day of which 3.6 will be soluble fibre. Data from the 2001/2 Expenditure and Food Survey (http://statistics.defra.gov.uk/esg/publications/efs/default.asp) indicate that the average intake of NSP in Scotland is 12.6 g per day. The proposed interventions are likely to bring intakes close to the Dietary Reference Value of 18 g per day but will not cause intakes to exceed the upper limit of 24 g per day set for individuals (Department of Health, 1991). The total duration of the intervention is 16 weeks, with 4 weeks run-in in a refined diet prior to randomisation into one of the three groups (12 weeks). |
| Primary outcome measure(s) |
All outcome measures were determined four times during the intervention: prior run-in (T0), after run-in period (4 weeks, baseline), at week 10 and week 16 (end of intervention):
1. Serum total and low density lipoprotein (LDL) cholesterol concentrations 2. Insulin sensitivity |
| Secondary outcome measure(s) | Measurement of vascular function and inflammation markers (vascular tonicity by pulse-wave velocity and pulse contour analysis, intercellular adhesion molecule 1 [ICAM-1], interleukin-6 [IL-6] and high sensitivity C-reactive protein [hsCRP]). All outcome measures were determined four times during the intervention: prior run-in (T0), after run-in period (4 weeks, baseline), at week 10 and week 16 (end of intervention). |
| Sources of funding | Food Standards Agency (UK) (ref: NO2035) |
| Trial website | |
| Publications | 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20685951 |
| Contact name | Dr Frank Thies |
| Address |
University of Aberdeen Medical School
Polwarth Building Foresterhill |
| City/town | Aberdeen |
| Zip/Postcode | AB25 2ZD |
| Country | United Kingdom |
| Sponsor | Food Standards Agency (UK) |
| Address |
Nutrition Division
Aviation House 125 Kingsway |
| City/town | London |
| Zip/Postcode | WC2B 6NH |
| Country | United Kingdom |
| Sponsor website: | http://www.food.gov.uk |
| Date applied | 04/12/2009 |
| Last edited | 12/08/2010 |
| Date ISRCTN assigned | 11/01/2010 |
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| © 2012 ISRCTN unless otherwise stated. | |
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