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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-08

Study Completion Date

2025-12-19

Brief Summary

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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.

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Detailed Description

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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

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Overweight or Obese Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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Tonic drink

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

Group Type ACTIVE_COMPARATOR

Breakfast meal challenge with tonic drink

Intervention Type OTHER

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

Placebo drink

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

Group Type PLACEBO_COMPARATOR

Breakfast meal challenge with placebo drink

Intervention Type OTHER

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

Interventions

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Breakfast meal challenge with tonic drink

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

Intervention Type OTHER

Breakfast meal challenge with placebo drink

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

Intervention Type OTHER

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, or
* unable or unwilling to provide blood samples.

Minimum Eligible Age

30 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No