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OpenTrials
Active, Not Recruiting

NCT Number: NCT05986253

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Limerick

Limerick, V94 T9PX, Ireland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Seaweed protein

Dietary Supplement

Novel protein extracted from seaweed

Maltodextrin

Dietary Supplement

maltodextrin solution

Primary outcomes

  1. Postprandial blood glucose area under the curve (AUC)

    Time frame: 120 minutes

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

Secondary outcomes

  1. Timecourse of blood glucose concentration

    Time frame: 0, 15, 30, 45, 60, 90, 120 minutes

    Timecourse of blood glucose concentration (measured as mmol/L)

  2. Postprandial serum insulin area under the curve (AUC)

    Time frame: 120 minutes

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

  3. Postprandial serum insulin concentration

    Time frame: 0, 15, 30, 45, 60, 90, 120 minutes

    Timecourse of serum insulin concentration (measured as mU/L)

Sponsors and collaborators

Lead sponsor

University of Limerick

Other

Registry information

Important dates

Study start
2023
Primary completion
2031
Study completion
2031
First posted
Aug 14, 2023
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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