BioDulse: The Effect of an Irish Seaweed Protein Extract on Glucose Control in Healthy Adults

Sponsor

University of Limerick (Other)

Overall Status

Recruiting

CT.gov ID

NCT05850429

Collaborator

(none)

Enrollment

Location

Arms

91.8

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 healthy population.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: Seaweed protein	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

A three arm, acute randomised, double blind crossover design feeding study will be used to establish the impact and dose response to co-ingestion of BioDulse (a protein hydrolysate from Irish seaweed) with maltodextrin on postprandial blood glucose and insulin concentrations.A three arm, acute randomised, double blind crossover design feeding study will be used to establish the impact and dose response to co-ingestion of BioDulse (a protein hydrolysate from Irish seaweed) with maltodextrin on postprandial blood glucose and insulin concentrations.

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

BioDulse: The Effect of an Irish Seaweed Protein Extract on Glucose Control in Healthy Adults

Actual Study Start Date :

May 9, 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: Seaweed protein Novel protein extracted from seaweed
Experimental: Low protein 0.6g/kg body mass maltodextrin PLUS 0.075g/kg body mass protein from Biodulse, in solution	Dietary Supplement: Seaweed protein Novel protein extracted from seaweed
Experimental: Medium 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

Arm

Intervention/Treatment

Placebo Comparator: Control

0.6g/kg body mass maltodextrin in solution.

Dietary Supplement: Seaweed protein

Novel protein extracted from seaweed

Experimental: Low protein

0.6g/kg body mass maltodextrin PLUS 0.075g/kg body mass protein from Biodulse, in solution

Dietary Supplement: Seaweed protein

Novel protein extracted from seaweed

Experimental: Medium 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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Yes

Inclusion Criteria:

Aged 18-67

Exclusion Criteria:

Terminal disease
Past medical history of vascular disease, cancer, diabetes, neurological, kidney, pulmonary, digestive (Coeliac disease), thyroidal disease, cognitive impairment;
Exclusively receiving enteral or parenteral nutrition,
Any conditions/anomalies that are contraindications to bioelectrical impedance analysis as per institutional risk assessment and SOP.

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:

NCT05850429

Other Study ID Numbers:

2022_12_14_EHS

First Posted:

May 9, 2023

Last Update Posted:

May 11, 2023

Last Verified:

Apr 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:

Study Results

No Results Posted as of May 11, 2023