Post-prandial glycaemic control and appetite regulation in healthy adults Nutritional, Metabolic, Endocrine
Conditions
Interventions
This is a double blind, randomised, placebo controlled, three arm crossover study conducted at the Centre for Nutraceuticals, University of Westminster. Each participant completes three intervention v
no head to head comparison between the two active interventions is prespecified.
Sponsors
Phynova Group Limited
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male and female participants aged 18 years and over 2. BMI between 18.5 and 30 kg/m² (lean and overweight individuals) 3. Generally healthy, with no clinically significant medical conditions as determined by screening 4. Stable use of permitted medications, including: 4.1. Oral contraceptives 4.2. Acetylsalicylic acid (aspirin) 4.3. Thyroxine 4.4. Vitamin and mineral supplements 4.5. Medications for hypertension or osteoporosis 5. Willing and able to comply with all study procedures 6. Able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Fasting blood glucose >6.9 mmol/L 2. Body mass index (BMI) >30 kg/m² 3. Known food allergies or intolerances, including lactose intolerance 4. Use of anti-hyperglycaemic medications or insulin 5. Major medical or surgical event requiring hospitalisation within the past 3 months 6. Presence of diseases or use of medications that affect digestion or nutrient absorption 7. Use of steroids, protease inhibitors, or antipsychotics (due to their effects on glucose metabolism and body fat distribution) 8. Use of medications known to affect glucose tolerance (excluding oral contraceptives) 9. Current participation in dieting or intentional weight-loss programmes 10. Consumption of >14 units of alcohol per week 11. Use of implanted medical devices such as pacemakers 12. Current smokers or users of nicotine products 13. Clinically significant depression or other mental health conditions that may interfere with study participation 14. Inability or unwillingness to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incremental area under the curve (iAUC) for postprandial blood glucose measured using venous whole glucose concentrations collected via an indwelling cannula. iAUC will be calculated using the trapezoidal method, subtracting baseline values to quantify the incremental glucose response. Measured at 0 to 120 minutes following consumption of the standardised test meal, with repeated sampling across the 2-hour postprandial period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incremental area under the curve (iAUC) for postprandial glucose measured using venous whole blood glucose concentrations with iAUC calculated via the trapezoidal method after baseline subtraction at 0–180 minutes following consumption of the standardised test meal;Incremental area under the curve (iAUC) for plasma insulin measured using plasma insulin concentrations analysed via appropriate assay with iAUC calculated using the trapezoidal method after baseline subtraction at 0–180 minutes following consumption of the standardised test meal;Incremental area under the curve (iAUC) for GLP-1 measured using plasma GLP-1 concentrations analysed via appropriate assay with iAUC calculated using the trapezoidal method after baseline subtraction at 0–180 minutes following consumption of the standardised test meal;Incremental area under the curve (iAUC) for PYY measured using plasma PYY concentrations analysed via appropriate assay with iAUC calculated using the trapezoidal method after baseline subtraction at 0–180 minutes following consumption of the standardised test meal;Peak postprandial concentration (Cmax) for glucose, insulin, GLP-1 and PYY measured using the highest venous plasma concentration observed during the sampling period at any timepoint within 0–180 minutes post-meal;Time to peak concentration (Tmax) for glucose, insulin, GLP-1 and PYY measured using the timepoint at which the maximum venous plasma concentration occurs, at any time within the 0–180 minute sampling window;Subjective appetite and satiety ratings measured using validated Visual Analogue Scale (VAS) questionnaires assessing hunger, fullness, satisfaction and prospective food intake, at at baseline and repeated intervals across the 0–180 minute postprandial period;Intrusive food-related thoughts measured using the Food Noise Questionnaire (FNQ) at 24 hours before each intervention visit and 24 hours after each visit;Energy intake and dietary composition over 24 hours measured using a structured | — |
Countries
England, United Kingdom
Contacts
Public ContactPreeti Jethwa
Outcome results
None listed