Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NO2035
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
Acronym
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
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
Condition
Overweight/moderately obese
Intervention
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).
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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
30/06/2005
Overall trial end date
30/06/2009
Reason abandoned
Eligibility
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
Patient
Age group
Adult
Gender
Both
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
30/06/2005
Recruitment end date
30/06/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Aberdeen Medical School
Aberdeen
AB25 2ZD
United Kingdom
Sponsor information
Organisation
Food Standards Agency (UK)
Sponsor details
Nutrition Division
Aviation House
125 Kingsway
London
WC2B 6NH
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Food Standards Agency (UK) (ref: NO2035)
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
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20685951
2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23940575
Publication citations
-
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.
-
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.