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Montbretin Clinical Trial (MbA)

Primary Purpose

Type 2 Diabetes

Status
Not yet recruiting
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Montbretin A
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 diabetes, Montbretin A

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Have diagnosed type-2 diabetes mellitus (previously had HbA1C ≥ 6.5) that is currently controlled by diet (currently HbA1C < 6.5) and no other medication In the opinion of the Medical Expert, have routine and normal dietary habits that include three meals a day; Normal hematological parameters as determined through screeningpre-study blood draw; Use of an effective barrier method of birth control throughout the study, surgical sterility, or menopausal for at least 2 years; Written informed consent; On the Medical Expert's opinion, capable of understanding the visit schedule requirement and study medication dosing requirements. Exclusion Criteria: Currently in poor health as determined by the Medical Expert; Currently on medication, except vitamins and/or birth control; Does not eat three regular meals a day; Currently or historically has/had impairment of gastro-intestinal function. (Specifically, patients who have/had; inflammatory bowel disease, colonic ulceration, partial intestinal obstruction, or in patients predisposed to intestinal obstruction, chronic intestinal diseases associated with marked disorders of digestion or absorption and in patients who suffer from states which may deteriorate as a result of increased gas formation in the intestine, e.g. larger hernias); Has travelled to a foreign country less than four (4) weeks prior to study entry; Has had surgery less than four (4) weeks a prior to study entry; Planned participation with other investigational drugs while participating in the study; Pregnant or lactating women; Known allergy to study medication or its components (non-medicinal ingredients); A history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits

Sites / Locations

  • Department of Family Practice

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Outcomes

Primary Outcome Measures

Maximum tolerated dose (MTD)
The MTD is defined as the minimum dose that results in a dose limiting toxicity in the form of gastro-intestinal adverse events (relevant flatulence and/or diarrhea as determined by the Gastrointestinal Symptom Rating Scale) in 33% of the test subjects.

Secondary Outcome Measures

Full Information

First Posted
April 11, 2023
Last Updated
April 11, 2023
Sponsor
University of British Columbia
Collaborators
Canadian Glycomics Network (GlycoNet)
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1. Study Identification

Unique Protocol Identification Number
NCT05826054
Brief Title
Montbretin Clinical Trial
Acronym
MbA
Official Title
Phase 1 Dose Escalating Study for Montbretin A
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Canadian Glycomics Network (GlycoNet)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this clinical trial is to establish that montbretin A is safe to consume and well tolerated for individuals with Type 2 Diabetes. The trial aims to determine a safe dosage range and identify any potential side effects. Participants will participate in the study over a period of time, during which the study participant will be ingesting montbretin A on a pre-determined schedule with continuous monitoring.
Detailed Description
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). MbA holds promise as a treatment for diabetes and obesity by limiting post-prandial glucose following a meal. The purpose of this trial is to establish that montbretin A is safe to consume and will show a better tolerability profile, with respect to gastrointestinal disturbances. This will be demonstrated by charting the amount and rate of colonic fermentation following a meal eaten with a dose of montbretin A. This is a Phase I study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 diabetes, Montbretin A

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Montbretin A
Intervention Description
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).
Primary Outcome Measure Information:
Title
Maximum tolerated dose (MTD)
Description
The MTD is defined as the minimum dose that results in a dose limiting toxicity in the form of gastro-intestinal adverse events (relevant flatulence and/or diarrhea as determined by the Gastrointestinal Symptom Rating Scale) in 33% of the test subjects.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Have diagnosed type-2 diabetes mellitus (previously had HbA1C ≥ 6.5) that is currently controlled by diet (currently HbA1C < 6.5) and no other medication In the opinion of the Medical Expert, have routine and normal dietary habits that include three meals a day; Normal hematological parameters as determined through screeningpre-study blood draw; Use of an effective barrier method of birth control throughout the study, surgical sterility, or menopausal for at least 2 years; Written informed consent; On the Medical Expert's opinion, capable of understanding the visit schedule requirement and study medication dosing requirements. Exclusion Criteria: Currently in poor health as determined by the Medical Expert; Currently on medication, except vitamins and/or birth control; Does not eat three regular meals a day; Currently or historically has/had impairment of gastro-intestinal function. (Specifically, patients who have/had; inflammatory bowel disease, colonic ulceration, partial intestinal obstruction, or in patients predisposed to intestinal obstruction, chronic intestinal diseases associated with marked disorders of digestion or absorption and in patients who suffer from states which may deteriorate as a result of increased gas formation in the intestine, e.g. larger hernias); Has travelled to a foreign country less than four (4) weeks prior to study entry; Has had surgery less than four (4) weeks a prior to study entry; Planned participation with other investigational drugs while participating in the study; Pregnant or lactating women; Known allergy to study medication or its components (non-medicinal ingredients); A history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits
Facility Information:
Facility Name
Department of Family Practice
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert J Petrella, MD, PhD
First Name & Middle Initial & Last Name & Degree
Steven G Withers, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Montbretin Clinical Trial

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