A randomised, double blinded, placebo-controlled crossover design clinical trial conducted at the Mary MacKillop Institute for Health Research (MMIHR, Australian Catholic University) for individuals with overweight/ obesity. This study will measure the postprandial glucose and hormone responses to a high-carbohydrate meal with/ without a liquid tonic drink.
Twenty individuals living with overweight/ obesity will be invited to attend the university laboratories on 2 separate occasions to participate in a postprandial (meal) challenge. Participants will consume the same high-carbohydrate meal on each visit, with or without a liquid tonic drink. This will be a cross-over design study, where participants will consume a placebo drink on the alternate visit. Participants will remain in the laboratory for 3-hours following the meal with a venous cannula in place, and have blood samples taken at regular timepoints. Blood samples will be analysed for glucose and appetite hormones. Participants will also wear a continuous glucose monitor throughout the period which encapsulates both study trials.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
20
High-carbohydrate containing breakfast meal with the addition of the tonic drink
High-carbohydrate containing breakfast meal with the addition of the placebo drink
Australian Catholic University
Melbourne, Victoria, Australia
RECRUITING3-hour postprandial glucose incremental area under the curve
Venous glucose concentrations measured over the 3 hour period following consumption of the breakfast meal and tonic drink/ placebo, and calculated using the trapezoid method, with T0 concentration as baseline
Time frame: 3 hours
3-hour postprandial insulin incremental area under the curve
Venous insulin concentrations measured over the 3 hour period following consumption of the breakfast meal and tonic drink/ placebo, and calculated using the trapezoid method, with T0 concentration as baseline
Time frame: 3-hours
3-hour interstitial postprandial glucose incremental area under the curve
The interstitial glucose levels observed for the 3 hours following consumption of the breakfast meal and tonic drink/placebo using continuous glucose monitors
Time frame: 3 hours
Matsuda index (Marker of whole-body postprandial insulin sensitivity)
This marker takes into account the 3- hour postprandial venous blood glucose and insulin measurements observed
Time frame: 3 hours
Venous blood C-peptide responses
3-hour postprandial C-peptide responses measured in venous blood as a marker of insulin secretion
Time frame: 3 hours
Venous blood insulin to glucagon ratio's at baseline (T0) and 30 minutes (T30)
Ratio of venous blood insulin to glucagon at baseline and 30 minutes (T0, T30) as a marker of hepatic glucose production.
Time frame: 30 minutes
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