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

NCT ID: NCT05850429

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-09
• Study Completion Date: 2023-10-06

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 healthy population.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Control

0.6g/kg body mass maltodextrin in solution.

Group Type: PLACEBO_COMPARATOR

Seaweed protein

Intervention Type: DIETARY_SUPPLEMENT

Novel protein extracted from seaweed

Low protein

0.6g/kg body mass maltodextrin PLUS 0.075g/kg body mass protein from Biodulse, in solution

Group Type: EXPERIMENTAL

Seaweed protein

Intervention Type: DIETARY_SUPPLEMENT

Novel protein extracted from seaweed

Medium protein

0.6g/kg body mass maltodextrin PLUS 0.15g/kg body mass protein from Biodulse, in solution

Group Type: EXPERIMENTAL

Seaweed protein

Intervention Type: DIETARY_SUPPLEMENT

Novel protein extracted from seaweed

Interventions

Seaweed protein

Novel protein extracted from seaweed

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 67 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Limerick

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Carson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Limerick

Locations

University of Limerick

Limerick, , Ireland

Countries

Ireland

Other Identifiers

2022_12_14_EHS

Identifier Type: -

Identifier Source: org_study_id