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

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 population with type 2 diabetes.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: Seaweed protein
* Dietary Supplement: Maltodextrin


Participation Criteria
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Eligibility Criteria
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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

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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No

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 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>0.6g/kg body mass maltodextrin in solution | Dietary Supplement: Maltodextrin<br>* maltodextrin solution<br>|
| Experimental: 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>Dietary Supplement: Maltodextrin<br>* maltodextrin solution<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 120 minutes | 120 minutes | 

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