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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Seaweed protein

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2023
• Primary Completion (Actual): October 6, 2023
• Study Completion (Actual): October 6, 2023

Study Registration Dates

• First Submitted: April 28, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2022_12_14_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