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

Sponsor

University of Limerick (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05986253

Collaborator

(none)

Enrollment

Location

Arms

88.8

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Dietary Supplement: Seaweed protein Dietary Supplement: Maltodextrin	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention 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.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:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Aug 7, 2023

Anticipated Primary Completion Date :

Oct 6, 2023

Anticipated Study Completion Date :

Jan 1, 2031

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Postprandial blood glucose area under the curve (AUC) [120 minutes]
Integrated area under curve of blood glucose concentration (measured as mmol/L) over 120 minutes

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 67 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Limerick	Limerick		Ireland	V94 T9PX

Sponsors and Collaborators

University of Limerick

Investigators

Principal Investigator: Brian Carson, PhD, University of Limerick

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Limerick

ClinicalTrials.gov Identifier:

NCT05986253

Other Study ID Numbers:

23_05_07_EHS

First Posted:

Aug 14, 2023

Last Update Posted:

Aug 17, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Aug 17, 2023