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

Healthy Clinical Trial

— BioDulse  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05850429
• Other study ID #: 2022_12_14_EHS
• Status: Completed
• Phase: N/A
• Start date: May 9, 2023
• Est. completion date: October 6, 2023

Study information

• Verified date: April 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 healthy population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 6, 2023
• Est. primary completion date: October 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Seaweed protein
Novel protein extracted from seaweed

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