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

NCT ID: NCT05986253

Last Updated: 2024-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-07

Study Completion Date

2031-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

0.6g/kg body mass maltodextrin in solution

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

maltodextrin solution

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

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

maltodextrin solution

Interventions

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Seaweed protein

Novel protein extracted from seaweed

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

maltodextrin solution

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Limerick

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian Carson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Limerick

Locations

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University of Limerick

Limerick, , Ireland

Site Status

Countries

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Ireland

Other Identifiers

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23_05_07_EHS

Identifier Type: -

Identifier Source: org_study_id

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