Montbretin Clinical Trial in Healthy Volunteers and Type 2 Diabetics
NCT05826054 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2024-10-15
Summary
The goal of this clinical trial is to test the investigational product, Montbretin A (MbA) in either individuals with type 2 diabetes (T2D) or healthy participants.
The main questions it aims to answer are:
* Safety of MbA
* Whether MbA has less side effects in comparison to other medications used to treat T2D
Participants will:
* Be given MbA at increasing amounts (10 mg to 300 mg) over a two-week treatment period, along with standardized meal;
* Undergo testing, including blood draws, blood sugar checks, electrocardiogram (ECG) and questionnaires.
Conditions
Interventions
- DIETARY_SUPPLEMENT
-
Montbretin A
The investigational product is 95% pure montbretin A (MbA), a glycosylated acyl-flavonol isolated from the corms (bulbs) of the Crocosmia plant through hot water extraction. It is a potent and specific inhibitor of human pancreatic amylase (HPA).
Sponsors & Collaborators
-
Michael Smith Foundation for Health Research
collaborator OTHER -
Canadian Glycomics Network (GlycoNet) - Networks of Centres of Excellence (NCE)
collaborator UNKNOWN -
Robert Petrella
lead OTHER
Principal Investigators
-
Robert Petrella, MD, PhD · University of British Columbia
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-12-01
- Primary Completion
- 2025-02-28
- Completion
- 2025-02-28
Countries
- Canada
Study Locations
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