Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Frank Thies


Contact details

University of Aberdeen Medical School
Polwarth Building
AB25 2ZD
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Comparison of effects of increased whole grain foods on markers of cardiovascular risk: a single centre, single blind, randomised controlled longitudinal study


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.

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

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type

Quality of life

Patient information sheet

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


Overweight/moderately obese


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 ( 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).

Intervention type



Not Applicable

Drug names

Primary outcome measure

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 measures

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).

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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

Participant type


Age group




Target number of participants

180 (60 per group)

Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University of Aberdeen Medical School
AB25 2ZD
United Kingdom

Sponsor information


Food Standards Agency (UK)

Sponsor details

Nutrition Division
Aviation House
125 Kingsway
United Kingdom

Sponsor type




Funder type


Funder name

Food Standards Agency (UK) (ref: NO2035)

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations


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

Basic results (scientific)

Publication list

2010 results in
2013 results in

Publication citations

  1. Results

    Tighe P, Duthie G, Vaughan N, Brittenden J, Simpson WG, Duthie S, Mutch W, Wahle K, Horgan G, Thies F, Effect of increased consumption of whole-grain foods on blood pressure and other cardiovascular risk markers in healthy middle-aged persons: a randomized controlled trial., Am. J. Clin. Nutr., 2010, 92, 4, 733-740, doi: 10.3945/ajcn.2010.29417.

  2. Results

    Tighe P, Duthie G, Brittenden J, Vaughan N, Mutch W, Simpson WG, Duthie S, Horgan GW, Thies F, Effects of wheat and oat-based whole grain foods on serum lipoprotein size and distribution in overweight middle aged people: a randomised controlled trial., PLoS ONE, 2013, 8, 8, e70436, doi: 10.1371/journal.pone.0070436.

Additional files

Editorial Notes