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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Seaweed protein


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 67 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>0.6g/kg body mass maltodextrin in solution. | Dietary Supplement: Seaweed protein<br>* Novel protein extracted from seaweed<br>|
| Experimental: Low protein<br>0.6g/kg body mass maltodextrin PLUS 0.075g/kg body mass protein from Biodulse, in solution | Dietary Supplement: Seaweed protein<br>* Novel protein extracted from seaweed<br>|
| Experimental: Medium protein<br>0.6g/kg body mass maltodextrin PLUS 0.15g/kg body mass protein from Biodulse, in solution | Dietary Supplement: Seaweed protein<br>* Novel protein extracted from seaweed<br>|

What is the study measuring?
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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 |