Effect of a Liquid Tonic Drink on Post-meal Glucose and Insulin Responses

NCT07030010 | Recruiting

• 1 other identifier: 2025-4309HC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight or Obese Adults

Keywords

Postprandial hormones; Mixed meal challenge; Tonic drink

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 3-hour postprandial insulin incremental area under the curve

  3-hours

• 3-hour interstitial postprandial glucose incremental area under the curve

  3 hours

• Matsuda index (Marker of whole-body postprandial insulin sensitivity)

  3 hours

• Venous blood C-peptide responses

  3 hours

• Venous blood insulin to glucagon ratio's at baseline (T0) and 30 minutes (T30)

  30 minutes

Study Arms (2)

Tonic drink

ACTIVE COMPARATOR

This arm will receive the tonic drink on their first postprandial challenge

Other: Breakfast meal challenge with tonic drink

Placebo drink

PLACEBO COMPARATOR

This arm will receive the placebo drink on their first postprandial challenge

Other: Breakfast meal challenge with placebo drink

Interventions

Breakfast meal challenge with tonic drink OTHER

High-carbohydrate containing breakfast meal with the addition of the tonic drink

Tonic drink

Breakfast meal challenge with placebo drink OTHER

High-carbohydrate containing breakfast meal with the addition of the placebo drink

Placebo drink

Eligibility Criteria

• Age: 30 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged ≥30-64 years
• Body Mass Index (BMI) of ≥27.0 kg/m2

You may not qualify if:

• 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.

Sponsors & Collaborators

• Australian Catholic University: lead

Study Sites (1)

Australian Catholic University

Melbourne, Victoria, 3065, Australia

RECRUITING

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Leonidas Karagounis, PhD

  Australian Catholic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evelyn Parr, PhD

CONTACT

+61 3 9230 8278; evelyn.parr@acu.edu.au

Katherine M Roberts-Thomson, PhD

CONTACT

+61 3 9230 8756; katherine.roberts-thomson@acu.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two arm, cross-over design where all participants will receive both conditions in different orders

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 19, 2025
• Study Start: July 8, 2025
• Primary Completion: December 19, 2025
• Study Completion: December 19, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Access Criteria: 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.

Locations

AU (1)