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Effect of whole grain foods on cardiovascular risk
ISRCTN ISRCTN27657880
DOI 10.1186/ISRCTN27657880
ClinicalTrials.gov identifier
EudraCT number
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 Not provided at time of registration
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
2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23940575
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 14/08/2013
Date ISRCTN assigned 11/01/2010
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