Postprandial glycaemic control Nutritional, Metabolic, Endocrine
Conditions
Interventions
The trial has a randomised cross over design and so each subject would act as their own control. Subjects are randomized to the trial using a 4x4 Latin Square block randomization, randomizing particip
Sponsors
Phynova Group Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Consent to study protocol 2. Aged 18-60 years 3. Body mass index (BMI) 20-29.9 kg/m² 4. Fasting blood glucose <6.1 mmol/l
Exclusion criteria
Exclusion criteria: 1. Aged 60 years 2. Pregnant or lactating 3. Body mass index (BMI) 30 kg/m² 4. Fasting blood glucose value >6.1 mmol/I 5. Any known food allergy or intolerance 6. Medical condition(s) or medication(s) known to affect glucose regulation or appetite and/or which influence digestion and absorption of nutrients (stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable) 7. Known history of diabetes mellitus or the use of antihyperglycaemic drugs or insulin to treat diabetes and related conditions 8. Known IBS, severe liver, heart or kidney problems or blood clotting disorders 9. Major medical or surgical event requiring hospitalization within the preceding 3 months 10. Use of steroids, protease inhibitors or antipsychotics (all of which have major effects on glucose metabolism and body fat distribution) 11. High vulnerability level for COVID-19 (assessed using this tool - https://alama.org.uk/covid- 19-medical-risk-assessment/) 12. Displayed any COVID-19 symptoms 14 days prior to any test session (high temperature, new continuous cough, loss or change to sense of smell or taste)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Blood glucose concentrations measured from capillary blood using HemoGue Glucose 201 DM analyser (units = mmol/L), measured at -5 min, 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min 2. Blood glucose incremental area under curve (iAUC) calculated from blood glucose concentrations using the trapezoid rule (units = mmol/L/min), measured at 60, 90, 120, 150 and 180 min 3. Peak blood glucose calculated from blood glucose curves (see above) (units = mmol/L) 4. Time of peak blood glucose calculated from blood glucose curves (see above) (units = minutes) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Plasma insulin concentration measured from capillary blood using electrochemiluminescence immunoassay using automated analyzer (Cobas E411) (units = µU/mL) at -5 min, 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min 2. Plasma insulin iAUC calculated from plasma insulin concentrations using the trapezoid rule (units = µU/mL/min), measured at 60, 90, 120, 150, and 180 min | — |
Countries
England, United Kingdom
Outcome results
None listed