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11 February 2012
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| [ Print-friendly version ] |
| Randomised controlled trial to test the impact of increased consumption of wholegrain foods on cardiovascular disease (CVD) risk |
| ISRCTN | ISRCTN83078872 |
| ClinicalTrials.gov identifier | |
| Public title | Randomised controlled trial to test the impact of increased consumption of wholegrain foods on cardiovascular disease (CVD) risk |
| Scientific title | |
| Acronym | The WHOLEheart study |
| Serial number at source | 05/Q0905/75 |
| Study hypothesis | This study will test the hypothesis that increased consumption of wholegrain foods as substitutes for refined grain alternatives in the diet results in reduced CVD risk through improvements in fasting lipid profiles, insulin sensitivity, endothelial function and a reduction in inflammatory status. |
| Lay summary | |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | N/A - this study looks at pre-disease/condition state |
| Participants - inclusion criteria | Men and women, aged 30-65 years and with a body mass index (BMI) >25 kg/m^2. |
| Participants - exclusion criteria |
Volunteers for the study will be excluded if they are:
1. Habitual consumers of wholegrain cereals and wholegrain bread 2. Individuals receiving clinical treatment for Type 2 diabetes, hyperlipidaemia or hypertension 3. Currently prescribed non-steroidal anti-inflammatory drugs (NSAIDS), aspirin, steroids or immunosuppressants 4. Allergic or intolerant to intervention foods 5. Planning to change dietary habits, increase physical activity, change body weight, move away from the study centre-locality or take a lengthy vacation during the time of the study 6. Heavy smokers (>20 cigarettes per day) 7. Individuals with a history of substance abuse or alcoholism 8. Currently planning pregnancy or have had a baby in the past 12 months 9. Individuals who have shown a recent weight change (>2 kg in past 1 month) |
| Anticipated start date | 18/07/2005 |
| Anticipated end date | 01/04/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 300 (150 at each centre) |
| Interventions |
Treatment A: Control, no intervention
Treatment B: Consuming three portions of wholegrain food per day for four months Treatment C: Consuming three portions of wholegrain food per day for two months increasing to six portions per day for a further two months |
| Primary outcome measure(s) | The primary outcome measure will be low-density lipoprotein (LDL) cholesterol. |
| Secondary outcome measure(s) |
1. Body Composition:
a. Body weight: in addition to the three main time-points weight will also be measured on volunteer’s collection of foods (i.e. four weekly intervals) b. Height c. Waist circumference d. Body composition by bio-impedance 2. Fasting Lipid Profile: a. Duplicate measures of total (high-density lipoprotein [HDL] and LDL cholesterol) triglycerides and non-esterified fatty acids. Distribution of lipoprotein sub-classes by nuclear magnetic resonance (NMR) (to be analysed by Dr Thies, University of Aberdeeen) 3. Insulin Sensitivity (HOMA, modified QUICKI): a. Duplicate fasting measures of glucose and insulin b. NEFA concentrations obtained during measurement of fasting lipid profile 4. Inflammatory Status and markers of endothelial function: a. Serum markers of the acute protein phase response, including sialic acid and C-reactive protein (CRP), fibrinogen and PAI-1 b. The plasma cytokine interleukin-6 (IL-6) as the principal stimulus for the production of acute phase proteins 31, 32 c. Plasma ICAM-1, VCAM-1 and e-selectin as markers of endothelial function 5. Blood pressure: a. Systolic and diastolic, at rest 6. Dietary change: a. Dietary change will be assessed using the validated FFQ. Change in intake of other dietary factors which may influence plasma enterolactone concentrations (i.e. fruit and vegetable intake) will be recorded to assess the impact of the dietary intervention on intake of other food groups. Any changes will be included as a factor in subsequent statistical analyses. |
| Sources of funding | Food Standards Agency (N02036) |
| Trial website | |
| Publications | 1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20307353 |
| Contact name | Dr Chris Seal |
| Address |
School of Agriculture
Food & Rural Development Agriculture Building University of Newcastle upon Tyne |
| City/town | Newcastle upon Tyne |
| Zip/Postcode | NE1 7RU |
| Country | United Kingdom |
| chris.seal@ncl.ac.uk | |
| Sponsor | Food Standards Agency (UK) |
| Address |
Aviation House
125 Kingsway |
| City/town | London |
| Zip/Postcode | WC2B 6NH |
| Country | United Kingdom |
| Date applied | 22/06/2005 |
| Last edited | 04/01/2011 |
| Date ISRCTN assigned | 25/07/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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