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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05986253

Enrollment

Registered

2023-08-14

Start date

2023-08-07

Completion date

2031-12-31

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

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.

Interventions

DIETARY_SUPPLEMENTSeaweed protein

Novel protein extracted from seaweed

DIETARY_SUPPLEMENTMaltodextrin

maltodextrin solution

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Intervention 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.

Eligibility

Sex/Gender

ALL

Age

18 Years to 67 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026