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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05850429
Acronym
BioDulse
Enrollment
11
Registered
2023-05-09
Start date
2023-05-09
Completion date
2023-10-06
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

Healthy

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.

Interventions

DIETARY_SUPPLEMENTSeaweed protein

Novel protein extracted from seaweed

Sponsors

University of Limerick
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Intervention model description

A three arm, acute randomised, double blind crossover design feeding study will be used to establish the impact and dose response to 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
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Postprandial blood glucose area under the curve (AUC)120 minIntegrated area under curve of blood glucose concentration (measured as mmol/L) over 120min

Secondary

MeasureTime frameDescription
Timecourse of blood glucose concentration0, 15, 30, 45, 60, 90, 120 minTimecourse of blood glucose concentration (measured as mmol/L)
Postprandial serum insulin area under the curve (AUC)120 minIntegrated area under curve of blood glucose concentration (measured as mU/L) over 120min
Postprandial serum insulin concentration0, 15, 30, 45, 60, 90, 120 minTimecourse of serum insulin concentration (measured as mU/L)

Countries

Ireland

Outcome results

None listed

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