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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07030010




Registration number
NCT07030010
Ethics application status
Date submitted
12/06/2025
Date registered
19/06/2025
Date last updated
1/07/2025

Titles & IDs
Public title
Effect of a Liquid Tonic Drink on Post-meal Glucose and Insulin Responses
Scientific 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.
Secondary ID [1] 0 0
2025-4309HC
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight or Obese Adults 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Breakfast meal challenge with tonic drink
Other interventions - Breakfast meal challenge with placebo drink

Active comparator: Tonic drink - This arm will receive the tonic drink on their first postprandial challenge

Placebo comparator: Placebo drink - This arm will receive the placebo drink on their first postprandial challenge


Other interventions: Breakfast meal challenge with tonic drink
High-carbohydrate containing breakfast meal with the addition of the tonic drink

Other interventions: Breakfast meal challenge with placebo drink
High-carbohydrate containing breakfast meal with the addition of the placebo drink
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
3-hour postprandial glucose incremental area under the curve
Timepoint [1] 0 0
3 hours
Secondary outcome [1] 0 0
3-hour postprandial insulin incremental area under the curve
Timepoint [1] 0 0
3-hours
Secondary outcome [2] 0 0
3-hour interstitial postprandial glucose incremental area under the curve
Timepoint [2] 0 0
3 hours
Secondary outcome [3] 0 0
Matsuda index (Marker of whole-body postprandial insulin sensitivity)
Timepoint [3] 0 0
3 hours
Secondary outcome [4] 0 0
Venous blood C-peptide responses
Timepoint [4] 0 0
3 hours
Secondary outcome [5] 0 0
Venous blood insulin to glucagon ratio's at baseline (T0) and 30 minutes (T30)
Timepoint [5] 0 0
30 minutes

Eligibility
Key inclusion criteria
* Aged =30-64 years
* Body Mass Index (BMI) of =27.0 kg/m2
Minimum age
30 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
30/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/12/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Australian Catholic University - Melbourne
Recruitment postcode(s) [1] 0 0
3065 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Australian Catholic University
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Leonidas Karagounis, PhD
Address 0 0
Australian Catholic University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Evelyn Parr, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 3 9230 8278
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07030010