Overweight or Obese Adults
Conditions
Keywords
Postprandial hormones, Mixed meal challenge, Tonic drink
Brief summary
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.
Detailed description
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.
Interventions
OTHERBreakfast meal challenge with tonic drink
High-carbohydrate containing breakfast meal with the addition of the tonic drink
OTHERBreakfast meal challenge with placebo drink
High-carbohydrate containing breakfast meal with the addition of the placebo drink
Sponsors
Australian Catholic University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Two arm, cross-over design where all participants will receive both conditions in different orders
Eligibility
Sex/Gender
ALL
Age
30 Years to 64 Years
Healthy volunteers
No
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, or * unable or unwilling to provide blood samples.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-hour postprandial glucose incremental area under the curve | 3 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-hour postprandial insulin incremental area under the curve | 3-hours | 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-hour interstitial postprandial glucose incremental area under the curve | 3 hours | The interstitial glucose levels observed for the 3 hours following consumption of the breakfast meal and tonic drink/placebo using continuous glucose monitors |
| Matsuda index (Marker of whole-body postprandial insulin sensitivity) | 3 hours | This marker takes into account the 3- hour postprandial venous blood glucose and insulin measurements observed |
| Venous blood C-peptide responses | 3 hours | 3-hour postprandial C-peptide responses measured in venous blood as a marker of insulin secretion |
| Venous blood insulin to glucagon ratio's at baseline (T0) and 30 minutes (T30) | 30 minutes | Ratio of venous blood insulin to glucagon at baseline and 30 minutes (T0, T30) as a marker of hepatic glucose production. |
Countries
Australia
Contacts
PRINCIPAL_INVESTIGATORLeonidas Karagounis, PhD
Australian Catholic University
Outcome results
None listed