Condition category
Nutritional, Metabolic, Endocrine
Date applied
04/12/2009
Date assigned
11/01/2010
Last edited
14/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Frank Thies

ORCID ID

Contact details

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

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

http://www.food.gov.uk

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

  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