BioDulse II: The Effect of an Irish Seaweed Protein Extract on Glucose Control in Adults With Type 2 Diabetes

April 8, 2024 updated by: University of Limerick
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Limerick, Ireland, V94 T9PX
        • University of Limerick

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
0.6g/kg body mass maltodextrin in solution
Dietary supplement: Maltodextrin
maltodextrin solution
Experimental: Protein
0.6g/kg body mass maltodextrin PLUS 0.15g/kg body mass protein from Biodulse, in solution
Dietary supplement: Seaweed protein
Novel protein extracted from seaweed
Dietary supplement: Maltodextrin
maltodextrin solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial blood glucose area under the curve (AUC)
Time Frame: 120 minutes
Integrated area under curve of blood glucose concentration (measured as mmol/L) over 120 minutes
120 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timecourse of blood glucose concentration
Time Frame: 0, 15, 30, 45, 60, 90, 120 minutes
Timecourse of blood glucose concentration (measured as mmol/L)
0, 15, 30, 45, 60, 90, 120 minutes
Postprandial serum insulin area under the curve (AUC)
Time Frame: 120 minutes
Integrated area under curve of blood glucose concentration (measured as mU/L) over 120 minutes
120 minutes
Postprandial serum insulin concentration
Time Frame: 0, 15, 30, 45, 60, 90, 120 minutes
Timecourse of serum insulin concentration (measured as mU/L)
0, 15, 30, 45, 60, 90, 120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Limerick

Investigators

  • Principal Investigator: Brian Carson, PhD, University of Limerick

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2023

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

December 31, 2031

Study Registration Dates

First Submitted

August 3, 2023

First Submitted That Met QC Criteria

August 3, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23_05_07_EHS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual data will be shared with researchers outside of those named on the institutional ethics application form.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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