Effect of a Liquid Tonic Drink on Post-meal Glucose and Insulin Responses
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.
Study details:
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.
Eligibility criteria
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Inclusion criteria
- Aged ≥30-64 years
- Body Mass Index (BMI) of ≥27.0 kg/m2
Exclusion criteria
- younger than 30 or 65 years or older
- a BMI less than 27.0 kg/m2
- have an allergy to any of the components in the plant-based tonic (see section 6)
- pregnant or breastfeeding
- regularly skipping breakfast (i.e. not consuming breakfast on 5/7 days per week)
- any diagnosed metabolic (e.g. diabetes), endocrine (e.g. hyperthyroidism), gastrointestinal (e.g. Crohn's) or cardiovascular (e.g. heart failure) abnormalities
- on an energy-restricted diet; significant weight fluctuation in the previous 3 months (>5% body weight)
- high alcohol consumption (>14 units/week) (as per Alcohol Drink Guidelines)
- medication that is used to treat blood glucose
- unable to attend in person testing sessions
- unable or unwilling to provide blood samples
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
BASIC_SCIENCE
Phase
- NA
Study ID
NCT07030010
Intervention or treatment
OTHER: Breakfast meal challenge with tonic drink
OTHER: Breakfast meal challenge with placebo drink
Conditions
- Overweight or Obese Adults
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Research sites nearby
Closest Location:
Australian Catholic University
Select from list below to view details:
Australian Catholic University
Melbourne, Victoria, Australia
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Who is running the clinical trial?
Australian Catholic University
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ACTIVE_COMPARATOR: Tonic drink
| Other: Breakfast meal challenge with tonic drink |
PLACEBO_COMPARATOR: Placebo drink
| Other: Breakfast meal challenge with placebo drink |
What is the study measuring?
Primary Outcome
| 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 |
Secondary Outcome
| 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 | 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 |
References
Clinical Trials Gov: Effect of a Liquid Tonic Drink on Post-meal Glucose and Insulin ResponsesOther trials to consider
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