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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tonic drink | Active Comparator | This arm will receive the tonic drink on their first postprandial challenge |
|
| Placebo drink | Placebo Comparator | This arm will receive the placebo drink on their first postprandial challenge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breakfast meal challenge with tonic drink | Other | High-carbohydrate containing breakfast meal with the addition of the tonic drink |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3-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 | 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3-hours |
| 3-hour interstitial postprandial glucose incremental area under the curve |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leonidas Karagounis, PhD | Australian Catholic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Australian Catholic University | Melbourne | Victoria | 3065 | Australia |
The data that support the findings of this study will be available from the corresponding author for a period of 36 months from publication, upon reasonable request for academic use. The data will not be made publicly available, as it contains information that could compromise research participant consent.
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Reasonable requests of data for academic use will be considered. Requests can be made to the corresponding author of the publication. Data will not be made publicly available as it contains information that could compromise research participant consent.
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| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Two arm, cross-over design where all participants will receive both conditions in different orders
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All researchers involved in undertaking the study and analysing the data will be blinded. Participants will be blinded. The dietitian preparing and serving the meal and drink will be unblinded.
| Breakfast meal challenge with placebo drink | Other | High-carbohydrate containing breakfast meal with the addition of the placebo drink |
|
The interstitial glucose levels observed for the 3 hours following consumption of the breakfast meal and tonic drink/placebo using continuous glucose monitors |
| 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 | 3 hours |
| Venous blood C-peptide responses | 3-hour postprandial C-peptide responses measured in venous blood as a marker of insulin secretion | 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. | 30 minutes |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |