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

Australian Catholic University (ACU)

Status: Not yet enrolling

Conditions: Overweight or Obese Adults

Treatments: Other: Breakfast meal challenge with tonic drink; Other: Breakfast meal challenge with placebo drink

Study type: Interventional

Funder types: Other

Identifiers

NCT07030010

2025-4309HC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 30 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Tonic drink

Active Comparator group

Description:

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

Treatment:

Other: Breakfast meal challenge with tonic drink

Placebo drink

Placebo Comparator group

Description:

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

Treatment:

Other: Breakfast meal challenge with placebo drink