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

NCT05986253 | Active Not Recruiting

• 1 other identifier: 23_05_07_EHS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Postprandial blood glucose area under the curve (AUC)

  Integrated area under curve of blood glucose concentration (measured as mmol/L) over 120 minutes

  120 minutes

Secondary Outcomes (3)

• Timecourse of blood glucose concentration

  0, 15, 30, 45, 60, 90, 120 minutes

• Postprandial serum insulin area under the curve (AUC)

  120 minutes

• Postprandial serum insulin concentration

  0, 15, 30, 45, 60, 90, 120 minutes

Study Arms (2)

Control

PLACEBO COMPARATOR

0.6g/kg body mass maltodextrin in solution

Dietary Supplement: Maltodextrin

Protein

EXPERIMENTAL

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

Dietary Supplement: Seaweed protein; Dietary Supplement: Maltodextrin

Interventions

Seaweed protein DIETARY_SUPPLEMENT

Novel protein extracted from seaweed

Protein

Maltodextrin DIETARY_SUPPLEMENT

maltodextrin solution

Control; Protein

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-67

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Limerick: lead

Study Sites (1)

University of Limerick

Limerick, V94 T9PX, Ireland

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Brian Carson, PhD

  University of Limerick

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 14, 2023
• Study Start: August 7, 2023
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: April 9, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)