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

Not Applicable

Active, not recruiting

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: Maltodextrin; Dietary Supplement: Seaweed protein

• Registration Number: NCT05986253
• Lead Sponsor: University of Limerick

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-03
• Study First Submitted QC: 2023-08-03
• Study Start: 2023-08-07
• Study First Posted: 2023-08-14
• Status Verified: 2023-11
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-09
• Primary Completion: 2031-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control	Maltodextrin	0.6g/kg body mass maltodextrin in solution
Protein	Maltodextrin	0.6g/kg body mass maltodextrin PLUS 0.15g/kg body mass protein from Biodulse, in solution
Protein	Seaweed protein	0.6g/kg body mass maltodextrin PLUS 0.15g/kg body mass protein from Biodulse, in solution

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Postprandial serum insulin concentration	0, 15, 30, 45, 60, 90, 120 minutes	Timecourse of serum insulin concentration (measured as mU/L)
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

Trial Locations

Locations (1)

University of Limerick; 🇮🇪 Limerick, Ireland