Type 2 DiabetesNCT05986253
BioDulse II: The Effect of an Irish Seaweed Protein Extract on Glucose Control in Adults With Type 2 Diabetes
A study testing Seaweed protein and Maltodextrin in people with Type 2 Diabetes, run by University of Limerick at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Seaweed protein and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteIreland
- Study dates
- 7 Aug 2023to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-67
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Seaweed protein, Maltodextrin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seaweed proteinDietary supplement
Novel protein extracted from seaweed
MaltodextrinDietary supplement
maltodextrin solution
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | 0.6g/kg body mass maltodextrin in solution Receives: Dietary Supplement: Maltodextrin |
| Protein | Experimental | 0.6g/kg body mass maltodextrin PLUS 0.15g/kg body mass protein from Biodulse, in solution Receives: Dietary Supplement: Seaweed protein; Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial blood glucose area under the curve (AUC)
Integrated area under curve of blood glucose concentration (measured as mmol/L) over 120 minutes
Measured: 120 minutes
Secondary outcomes (3)
Timecourse of blood glucose concentration
Timecourse of blood glucose concentration (measured as mmol/L)
Measured: 0, 15, 30, 45, 60, 90, 120 minutes
Postprandial serum insulin area under the curve (AUC)
Integrated area under curve of blood glucose concentration (measured as mU/L) over 120 minutes
Measured: 120 minutes
Postprandial serum insulin concentration
Timecourse of serum insulin concentration (measured as mU/L)
Measured: 0, 15, 30, 45, 60, 90, 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start7 Aug 2023
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Carson, PhD, Principal investigator, University of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986253
- Sponsor's protocol ID
- 23_05_07_EHS
- Status last verified
- Nov 2023
- First submitted
- 3 Aug 2023
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual data will be shared with researchers outside of those named on the institutional ethics application form.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BioDulse II: The Effect of an Irish Seaweed Protein Extract on Glucose Control in Adults With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05986253
- Acronym / sponsor ID
- 23_05_07_EHS
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: Maltodextrin0.6g/kg body mass maltodextrin in solution |
| Protein | Experimental | Dietary Supplement: Seaweed protein, Dietary Supplement: Maltodextrin0.6g/kg body mass maltodextrin PLUS 0.15g/kg body mass protein from Biodulse, in solution |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged 18-67
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seaweed proteinNovel protein extracted from seaweed | Dietary supplement | Protein |
| Maltodextrinmaltodextrin solution | Dietary supplement | Control, Protein |
Primary outcome
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
3 secondary outcomes
Timecourse of blood glucose concentration
Time frame: 0, 15, 30, 45, 60, 90, 120 minutes
Postprandial serum insulin area under the curve (AUC)
Time frame: 120 minutes
Postprandial serum insulin concentration
Time frame: 0, 15, 30, 45, 60, 90, 120 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: No. No individual data will be shared with researchers outside of those named on the institutional ethics application form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Carson, PhD principal investigator
University of Limerick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seaweed protein and Maltodextrin in people with Type 2 Diabetes, run by University of Limerick at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial blood glucose area under the curve (AUC) (time frame: 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.