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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05986253
• Other study ID #: 23_05_07_EHS
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 7, 2023
• Est. completion date: December 31, 2031

Study information

• Verified date: November 2023
• Source: University of Limerick
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 31, 2031
• Est. primary completion date: December 31, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Seaweed protein
Novel protein extracted from seaweed
• Maltodextrin
maltodextrin solution

Locations

Country	Name	City	State
Ireland	University of Limerick	Limerick

Sponsors (1)

Lead Sponsor	Collaborator
University of Limerick

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Timecourse of blood glucose concentration	Timecourse of blood glucose concentration (measured as mmol/L)	0, 15, 30, 45, 60, 90, 120 minutes
Secondary	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
Secondary	Postprandial serum insulin concentration	Timecourse of serum insulin concentration (measured as mU/L)	0, 15, 30, 45, 60, 90, 120 minutes