Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06315725

Effect of Artificial Sweetener (AFS) on Glucose Metabolism in Patients with Type 1 Diabetes (T1D)

The goal of this randomized crossover study is to test the prediction that consuming carbohydrates will affect insulin release differently depending on whether Non-Nutritive Sweeteners (NNSs) are consumed simultaneously. We aim to determine whether the predicted effects are associated with oral or post-oral sweet taste receptor signaling,. Our study will focus on patients diagnosed with type 1 diabetes (T1D) who are using an artificial pancreas (AP) system, as it allows us to monitor glucose and insulin levels over time.

Participants will drink four different flavored beverages, some with sweet taste blockade and some without, in a counter-balanced order. They will then rate the sweetness of each beverage, and we will collect data from their AP system to monitor insulin and glucose level.

To achieve this, we will conduct a pilot study to assess the effectiveness and best timing of sweet taste blockade in healthy individuals. Insights gained from the pilot study will inform the main study.

Sucralose will be used as the NNS, maltodextrin as the carbohydrate, and Gymnema Sylvestre (GS) as the sweet taste receptor blocker.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Type 1 Diabetes (T1D) Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Healthy Subjects Hyperinsulinism Immune System Diseases Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Innovative Medicine, The Research Institute of the McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location status: Recruiting

Location contact

Golnaz Arjmand, Postdoctoral Researcher

CONTACT

[email protected]

514-398-3020

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants with a diagnosis of T1D
  • HbA1C ≤ 8 %
  • Insulin pump therapy
  • Adults of any gender or biological sex aged 18-45 years old,
  • Body Mass Index (BMI) between 18.5-29.9 kg/m,
  • Non-smokers,
  • English or French speaker. ●. Who can consume chicken and fish

Exclusion criteria

  • A major medical diagnosis that could potentially influence metabolic dysfunction
  • A major medical diagnosis other than T1D,
  • Alcohol or substance use disorder,
  • Eating disorder or history of malabsorptive syndrome,
  • Inflammatory bowel disease,
  • Self-reported impairment in taste or smell,
  • A known taste or smell dysfunction (e.g., anosmia),
  • Active pregnancy and/or lactation,
  • Food allergies or intolerances,
  • Dislike of the test beverages,
  • History of bariatric surgery at any point in the past ●. Regular consumer of Gymnema sylvestre

Treatment and study plan

Sweet taste perception with/without sweet taste blockade

Other

In our study, we will use our four different novel flavored beverages, with and without a sweet taste blockade.

Primary outcomes

  1. Effectiveness and optimal time course of sweet test blockade on sweet taste perception in healthy individuals

    Time frame: from enrollment to the end of treatment at 4 weeks

    our aim is to test whether the impact of consuming NNS with carbohydrates on glucose metabolism is related to oral or post-oral sweet taste receptor signaling.

  2. Mean plasma glucose, basal and bolus insulin changes in individuals with T1D on AP following beverage consumption.

    Time frame: From enrollment to the end of treatment at 4 weeks

    Consuming NNS alongside carbohydrates affects glucose metabolism differently compared to carbohydrates alone in participants with type 1 diabetes (T1D) using an artificial pancreas (AP) system for exogenous insulin production

Secondary outcomes

  1. Resting Energy Expenditure (REE) and nutrient partitioning changes in individuals with T1D on AP following beverage consumptionT1D on AP following beverage consumption

    Time frame: from enrollment to the end of treatment at 4 weeks

    To test whether the co-ingestion of the NNS with carbohydrate can result in changes in post-ingestion metabolism, we plan to employ indirect calorimetry (IC) to evaluate resting energy expenditure (REE) before and after flavoured beverages consumption.

Study contacts

Contact information is provided by the study sponsor or research team.

Golnaz Arjmand, PhD

CONTACT

[email protected]

514-398-3020

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Registry information

Official study title

A Randomized Cross-Over Study to Investigate the Effect of the Non-Nutritive Sweetener Sucralose on Glucose Metabolism in Patients with Type 1 Diabetes

Acronym: AFS_T1D

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Mar 18, 2024
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.