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WHolegrain and IMmunity study

Effect of a wholegrain diet on markers of immune function, inflammation, glucose metabolism and gut health

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN36521837
Enrollment
40
Registered
2013-05-20
Start date
2011-03-14
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular health, gut health, inflammation Circulatory System

Interventions

Wholegrain foods vs refined grain foods 1. Intervention period of 6 weeks, during which subjects will be either asked to consume WG products and achieve a daily intake of at least 80 g of WG per day

Sponsors

Cereal Partners Worldwide (Switzerland)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy 2. Age 40-65y 3. Not on prescribed medication 4. Body mass index between 20 and 35 5. Low habitual consumption of wholegrain (<24g/d or 1.5 servings)

Exclusion criteria

Exclusion criteria: 1. Diabetes, heart problems, stroke, vascular disease, inflammatory disease, renal/bowel/liver disease, pancreatitis 2. Any prescribed medication (including aspirin) 3. Asthma 4. Allergies 5. Smoking 6. Vegan 7. Eating out >3 times per week 8. On fish oil or other supplements 9. History of alcohol misuse 10. Consumption of alcohol of >21 units for men or >15 units for women 11. On weight-reducing diets 12. Intense aerobic exercise more than 3x per week 13. Participating in another clinical trial 12. Regular travel 13. Flu vaccination in previous 12 months or planned vaccination during next 12 months 14. Prebiotic or probiotics or antibiotics for 3 months prior

Design outcomes

Primary

MeasureTime frame
1. Dietary intake assessed by questionnaire (daily during intervention) 2. Gut health assessed by questionnaire and microbiological analysis of stool samples (beginning and end of each arm of intervention) 3. Immune cell function (phagocytosis, natural killer cell activity, T cell activation) assessed by flow cytometry (beginning and end of each arm of intervention)

Secondary

MeasureTime frame
1. Salivary IgA levels assessed by ELISA (beginning and end of each arm of intervention) 2. Blood lipids, glucose and insulin assessed by automatic analyser (beginning and end of each arm of intervention) 3. Plasma alkylresorcinols analysed by sponsor (beginning and end of each arm of intervention) 4. Inflammatory and metabolic markers analysed by Luminex (beginning and end of each arm of intervention)

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 18, 2026