Back to resultsBioDulse II: The Effect of an Irish Seaweed Protein Extract on Glucose Control in Adults With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Seaweed protein
Maltodextrin
Sponsored by
About this trial
This is an interventional basic science trial for Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria: Aged 18-67 Exclusion Criteria: Terminal disease Exclusively receiving enteral or parenteral nutrition Any conditions/anomalies that are contraindications to bioelectrical impedance analysis as per institutional risk assessment and standard operating procedures Past medical history of cancer, neurological, kidney, pulmonary, digestive (Coeliac disease), thyroidal disease, cognitive impairment
Sites / Locations
- University of LimerickRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control
Protein
Arm Description
0.6g/kg body mass maltodextrin in solution
0.6g/kg body mass maltodextrin PLUS 0.15g/kg body mass protein from Biodulse, in solution
Outcomes
Primary Outcome Measures
Postprandial blood glucose area under the curve (AUC)
Integrated area under curve of blood glucose concentration (measured as mmol/L) over 120 minutes
Secondary Outcome Measures
Timecourse of blood glucose concentration
Timecourse of blood glucose concentration (measured as mmol/L)
Postprandial serum insulin area under the curve (AUC)
Integrated area under curve of blood glucose concentration (measured as mU/L) over 120 minutes
Postprandial serum insulin concentration
Timecourse of serum insulin concentration (measured as mU/L)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05986253
Brief Title
BioDulse II: The Effect of an Irish Seaweed Protein Extract on Glucose Control in Adults With Type 2 Diabetes
Official Title
BioDulse II: The Effect of an Irish Seaweed Protein Extract on Glucose Control in Adults With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 7, 2023 (Actual)
Primary Completion Date
October 6, 2023 (Anticipated)
Study Completion Date
January 1, 2031 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Limerick
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Co-ingesting protein with carbohydrate is an effective way to improve postprandial glucose handling. The investigators have isolated and identified a bioactive protein extracted from seaweed. The investigators aim to explore how varying doses of seaweed protein influence postprandial glycaemia and insulinaemia in a population with type 2 diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
A two arm, acute, randomised, double blind, placebo controlled, crossover design feeding study will be used to establish the impact of co-ingestion of BioDulse (a protein hydrolysate from Irish seaweed) with maltodextrin on postprandial blood glucose and insulin concentrations.
Masking
Participant
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
0.6g/kg body mass maltodextrin in solution
Arm Title
Protein
Arm Type
Experimental
Arm Description
0.6g/kg body mass maltodextrin PLUS 0.15g/kg body mass protein from Biodulse, in solution
Intervention Type
Dietary Supplement
Intervention Name(s)
Seaweed protein
Intervention Description
Novel protein extracted from seaweed
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
maltodextrin solution
Primary Outcome Measure Information:
Title
Postprandial blood glucose area under the curve (AUC)
Description
Integrated area under curve of blood glucose concentration (measured as mmol/L) over 120 minutes
Time Frame
120 minutes
Secondary Outcome Measure Information:
Title
Timecourse of blood glucose concentration
Description
Timecourse of blood glucose concentration (measured as mmol/L)
Time Frame
0, 15, 30, 45, 60, 90, 120 minutes
Title
Postprandial serum insulin area under the curve (AUC)
Description
Integrated area under curve of blood glucose concentration (measured as mU/L) over 120 minutes
Time Frame
120 minutes
Title
Postprandial serum insulin concentration
Description
Timecourse of serum insulin concentration (measured as mU/L)
Time Frame
0, 15, 30, 45, 60, 90, 120 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18-67
Exclusion Criteria:
Terminal disease
Exclusively receiving enteral or parenteral nutrition
Any conditions/anomalies that are contraindications to bioelectrical impedance analysis as per institutional risk assessment and standard operating procedures
Past medical history of cancer, neurological, kidney, pulmonary, digestive (Coeliac disease), thyroidal disease, cognitive impairment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Carson, PhD
Phone
+353 061 234943
Email
brian.carson@ul.ie
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Carson, PhD
Organizational Affiliation
University of Limerick
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Limerick
City
Limerick
ZIP/Postal Code
V94 T9PX
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Carson, PhD
Phone
+353 61 234943
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No individual data will be shared with researchers outside of those named on the institutional ethics application form.
Learn more about this trial
BioDulse II: The Effect of an Irish Seaweed Protein Extract on Glucose Control in Adults With Type 2 Diabetes
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