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

University of Limerick

Status: Active, not recruiting

Conditions: Type 2 Diabetes

Treatments: Dietary Supplement: Seaweed protein; Dietary Supplement: Maltodextrin

Study type: Interventional

Funder types: Other

Identifiers

NCT05986253

23_05_07_EHS

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 67 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

0.6g/kg body mass maltodextrin in solution

Treatment:

Dietary Supplement: Maltodextrin

Protein

Experimental group

Description:

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

Treatment:

Dietary Supplement: Maltodextrin

Dietary Supplement: Seaweed protein