Overweight or Obese AdultsNCT07030010
Effect of a Liquid Tonic Drink on Post-meal Glucose and Insulin Responses
A study testing Breakfast meal challenge with tonic drink in people with Overweight or Obese Adults, run by Australian Catholic University at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 64 years
- Conditions the study is for
- Overweight or Obese Adults
- What is being tested?
- Breakfast meal challenge with tonic drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- 8 Jul 2025to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged ≥30-64 years
- Body Mass Index (BMI) of ≥27.0 kg/m2
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Efficacy of a Commercially Available Multi-ingredient Liquid Tonic Drink on Postprandial Glycemia in Men and Women With Overweight and/or Obesity.
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.
Read the 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.
- Conditions
- Overweight or Obese Adults
- Being tested
- Breakfast meal challenge with tonic drink, Breakfast meal challenge with placebo drink
- Keywords
- Postprandial hormones, Mixed meal challenge, Tonic drink
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breakfast meal challenge with tonic drinkOther
High-carbohydrate containing breakfast meal with the addition of the tonic drink
Breakfast meal challenge with placebo drinkOther
High-carbohydrate containing breakfast meal with the addition of the placebo drink
| Study group | Role | What they receive |
|---|---|---|
| Tonic drink | Active comparator | This arm will receive the tonic drink on their first postprandial challenge Receives: Other: Breakfast meal challenge with tonic drink |
| Placebo drink | Placebo comparator | This arm will receive the placebo drink on their first postprandial challenge Receives: Other: Breakfast meal challenge with placebo drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 hours
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 3 hours
Venous blood C-peptide responses
3-hour postprandial C-peptide responses measured in venous blood as a marker of insulin secretion
Measured: 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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start8 Jul 2025
- Primary completion19 Dec 2025
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or Obese AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Two arm, cross-over design where all participants will receive both conditions in different orders
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Australian Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leonidas Karagounis, PhD, Principal investigator, Australian Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030010
- Sponsor's protocol ID
- 2025-4309HC
- Status last verified
- May 2026
- First submitted
- 12 Jun 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Efficacy of a Commercially Available Multi-ingredient Liquid Tonic Drink on Postprandial Glycemia in Men and Women With Overweight and/or Obesity.
- ClinicalTrials.gov ID
- NCT07030010
- Acronym / sponsor ID
- 2025-4309HC
- Conditions
- Overweight or Obese Adults
- Keywords
- Postprandial hormones, Mixed meal challenge, Tonic drink
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Australian Catholic UniversityUniversity, hospital or other
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two arm, cross-over design where all participants will receive both conditions in different orders
| Arm | Type | Receives |
|---|---|---|
| Tonic drink | Active comparator | Other: Breakfast meal challenge with tonic drinkThis arm will receive the tonic drink on their first postprandial challenge |
| Placebo drink | Placebo comparator | Other: Breakfast meal challenge with placebo drinkThis arm will receive the placebo drink on their first postprandial challenge |
Who may qualify
- Ages
- 30 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged ≥30-64 years
- Body Mass Index (BMI) of ≥27.0 kg/m2
Key exclusion criteria (11 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breakfast meal challenge with tonic drinkHigh-carbohydrate containing breakfast meal with the addition of the tonic drink | Other | Tonic drink |
| Breakfast meal challenge with placebo drinkHigh-carbohydrate containing breakfast meal with the addition of the placebo drink | Other | Placebo drink |
Primary outcome
3-hour postprandial glucose incremental area under the curve
Time frame: 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
5 secondary outcomes
3-hour postprandial insulin incremental area under the curve
Time frame: 3-hours
3-hour interstitial postprandial glucose incremental area under the curve
Time frame: 3 hours
Matsuda index (Marker of whole-body postprandial insulin sensitivity)
Time frame: 3 hours
Venous blood C-peptide responses
Time frame: 3 hours
Venous blood insulin to glucagon ratio's at baseline (T0) and 30 minutes (T30)
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonidas Karagounis, PhD principal investigator
Australian Catholic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breakfast meal challenge with tonic drink in people with Overweight or Obese Adults, run by Australian Catholic University at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-hour postprandial glucose incremental area under the curve (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.