Effect of regular mealtime inclusion of oat-based products on glycaemic response and post-prandial inflammation in type 2 diabetes

Effect of regular mealtime inclusion of oat-based products on glycaemic response and post-prandial inflammation in type 2 diabetes: a randomised cross-over study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12655129

Enrollment

Registered

2009-05-29

Start date

2008-02-01

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Dietary management of type 2 diabetes Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus

Interventions

Participating individuals will follow a randomised cross-over protocol and will follow both conventional diet advice and a modified diet, based on oat products each for an 8-week period. Standard diet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Men and post-menopausal women 2. Type 2 diabetes managed by diet alone 3. HbA1c not greater than 7.5% 4. Aged 40 - 75 years

Exclusion criteria

Exclusion criteria: 1. Significant liver, renal, cardiovascular or psychiatric illness 2. Medications that might invalidate the study results (including corticosteroids, hormone replacement therapy [HRT], anticoagulants, aspirin and statins)

Design outcomes

Primary

Measure	Time frame
1. Diabetes control assessed by HbA1c using Diabetes Control and Complications Trial (DCCT) aligned laboratory equipment 2. Post-prandial glycaemia assessed by a 3-day period of continuous blood glucose monitoring at weeks 0, 8 and 12 (Medtronic Minimed device) and glycaemic response to a standard test meal carried out at weeks 0, 8 and 16 3. Post-prandial inflammatory responses to a standard test meal carried out at weeks 0, 8 and 16 (C-reactive protein [CRP], tumour necrotising factor-alpha [TNF-alpha] and interleukin-6 [IL6] using bead array kits) 4. Measurements of platelet activation status by a combination of functional studies, measurement of surrogate markers such as P-selectin and platelet microparticles at weeks 0, 8 and 16 5. Insulin resistance measured at weeks 0, 8 and 16 by measurement of plasma insulin and glucose in the fasting state and calculation of HOMAIR and HOMAbeta-cell 6. Markers of oxidative stress in the fasting and post-prandial state at 0, 8 and 16 weeks will be assessed in the Free Radical Research Laboratory, Inverness by oxygen radical antioxidant capacity (ORAC), 4-hydroxynonenal/malondialdehyde (TBARS commercial assay kit; measure of lipid peroxidation) and urinary isoprostanes/creatinine ratio 7. Post-prandial insulin responses measured at 0, 8 and 16 weeks following a standard test meal	—

Measure

Time frame

1. Diabetes control assessed by HbA1c using Diabetes Control and Complications Trial (DCCT) aligned laboratory equipment 2. Post-prandial glycaemia assessed by a 3-day period of continuous blood glucose monitoring at weeks 0, 8 and 12 (Medtronic Minimed device) and glycaemic response to a standard test meal carried out at weeks 0, 8 and 16 3. Post-prandial inflammatory responses to a standard test meal carried out at weeks 0, 8 and 16 (C-reactive protein [CRP], tumour necrotising factor-alpha [TNF-alpha] and interleukin-6 [IL6] using bead array kits) 4. Measurements of platelet activation status by a combination of functional studies, measurement of surrogate markers such as P-selectin and platelet microparticles at weeks 0, 8 and 16 5. Insulin resistance measured at weeks 0, 8 and 16 by measurement of plasma insulin and glucose in the fasting state and calculation of HOMAIR and HOMAbeta-cell 6. Markers of oxidative stress in the fasting and post-prandial state at 0, 8 and 16 weeks will be assessed in the Free Radical Research Laboratory, Inverness by oxygen radical antioxidant capacity (ORAC), 4-hydroxynonenal/malondialdehyde (TBARS commercial assay kit; measure of lipid peroxidation) and urinary isoprostanes/creatinine ratio 7. Post-prandial insulin responses measured at 0, 8 and 16 weeks following a standard test meal

—

Secondary

Measure	Time frame
1. Plasma enterolactone will be measured as a marker of wholegrain consumption at 0, 8 and 16 weeks 2. Weight, body mass index (BMI), waist circumference, blood pressure and skinfold thickness measured at 0, 8 and 16 weeks 3. Standard questionnaires used routinely at the Rowett Institute of Nutrition and Health will be used to assess quality of life (using brief WHO-QOL questionnaire) exercise habits (using IPAQ questionnaire) and perception of diabetes (using the IPQ-R diabetes questionnaire) at 0, 8 and 16 weeks 4. Assessment of dietary intake will be undertaken at 0, 8 and 16 weeks using a weighed food diary 5. Assessment of hunger, satiety and palatability of the diet using hourly Visual Analogue Scale questionnaires at 0, 8 and 16 weeks	—

Measure

Time frame

1. Plasma enterolactone will be measured as a marker of wholegrain consumption at 0, 8 and 16 weeks 2. Weight, body mass index (BMI), waist circumference, blood pressure and skinfold thickness measured at 0, 8 and 16 weeks 3. Standard questionnaires used routinely at the Rowett Institute of Nutrition and Health will be used to assess quality of life (using brief WHO-QOL questionnaire) exercise habits (using IPAQ questionnaire) and perception of diabetes (using the IPQ-R diabetes questionnaire) at 0, 8 and 16 weeks 4. Assessment of dietary intake will be undertaken at 0, 8 and 16 weeks using a weighed food diary 5. Assessment of hunger, satiety and palatability of the diet using hourly Visual Analogue Scale questionnaires at 0, 8 and 16 weeks

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026