Changes in concentrations of biomarkers in response to changing wholegrain intake Nutritional, Metabolic, Endocrine
Conditions
Interventions
The study is a randomised dietary intervention based on a two-group parallel design with increasing intake of wholegrain wheat or rye to validate two proposed groups of biomarkers of wholegrain intake
Sponsors
Food Standards Agency (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Males and females aged over 18 years
Exclusion criteria
Exclusion criteria: 1. Allergies or intolerances to intervention foods 2. Individuals receiving any form of clinical treatment, and/or taking prescribed medications (clinical treatment will affect metabolic profile and/or bioavailability of nutrients from the intervention diet, potentially masking true dietary effects) 3. Individuals taking any form of dietary supplements (dietary supplements may affect metabolic profile and/or bioavailability of nutrients from the intervention diet, potentially masking true dietary effects) 4. Having dietary restrictions, apart from being a vegetarian (for example being on a detox or slimming diet) (some dietary restrictions could interfere with metabolic profile in response to wholegrain diet) 5. Planning to change dietary habits, increase physical activity, change body weight, move away from the study centre locality or to take a lengthy vacation during the time of the study (approximately 12 weeks) 6. Smokers (may affect metabolic profile through increased oxidative stress) 7. History of alcoholism or substance abuse (may affect compliance to dietary intervention and/or metabolic profile) 8. Body Mass Index 30 kg/m2 (very underweight or overweight individuals are likely to have disturbed metabolic profiles and metabolic response to diet) 9. Currently pregnant, planning pregnancy or having had a baby in the past 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-response changes in plasma and urine concentrations of alkyresorcinols determined by gas chromatography mass spectroscopy, and mammalian lignans determined by high-performance liquid chromatography with Coularray detection. Samples collected after 4 weeks washout (wholegrain free), then 4 weeks consuming three servings of wholegrain per day and, finally, after a further 4 weeks consuming six servings of wholegrain per day. | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma and urine 'metabolome' profile identified by targeted and untargeted metabolite analysis by comprehensive mass spectroscopy analysis. Samples collected after 4 weeks washout (wholegrain free), then 4 weeks consuming three servings of wholegrain per day and, finally, after a further 4 weeks consuming six servings of wholegrain per day. | — |
Countries
United Kingdom
Outcome results
None listed