N/A - this study looks at pre-disease/condition state Not Applicable
Conditions
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 i
Sponsors
Food Standards Agency (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men and women, aged 30-65 years and with a body mass index (BMI) >25 kg/m^2
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Low-density lipoprotein (LDL) cholesterol | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed