Blood GlucoseNCT02853916
Efficacy of a Brown Seaweed Powder for Glycemic Control
A study testing 500 mg InSea2® and 250 mg InSea2® in people with Blood Glucose, run by University of Manitoba at 1 site in Canada.
Trial summary
The objectives of this trial are to confirm efficacy in human of a brown seaweed powder and explore dose-response relationship by comparing two different doses. The primary endpoint is incremental area under the curve (iAUC, mmol*min/L) for blood glucose. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose
- What is being tested?
- 500 mg InSea2® and 250 mg InSea2®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2016to 25 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females aged between 18-45 y
- Normoglycemic (fasting blood glucose <5.6 mmol/L)
- Body mass index (BMI) 18.5-29.9 kg/m2
- Able to consume bread products
Who cannot join
- Fasting blood glucose > 5.6 mmol/L
- Systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg
- Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease
- Presence of a gastrointestinal disorder within the past year
- Presence of major gastrointestinal surgeries
- Thyroid problems
Show all 12Show fewer
- Smokers
- Consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect blood glucose or that could affect the outcome of the study as per investigator's judgement
- Women that are currently pregnant or lactating, or not using an appropriate contraception method
- Excessive alcohol intake (more than 2 drinks per day or more than 9 drinks per week)
- Allergic to shellfish (crab) or molluscs
- Weight gain or loss of at least 10lbs in previous three months
Trial locations and contacts
1 site in 1 country.
Canada1 site
Richardson Centre for Functional Foods and Nutraceuticals
Winnipeg, Manitoba, R3T 2N2
About this study
The objectives of this trial are to confirm efficacy in human of a brown seaweed powder and explore dose-response relationship by comparing two different doses.
The primary endpoint is incremental area under the curve (iAUC, mmol*min/L) for blood glucose.
- Conditions
- Blood Glucose
- Being tested
- 500 mg InSea2®, 250 mg InSea2®, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
500 mg InSea2®Dietary supplement
250 mg InSea2®Dietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 500 mg InSea2® | Active comparator | Not described Receives: Dietary Supplement: 500 mg InSea2® |
| 250 mg InSea2® | Active comparator | Not described Receives: Dietary Supplement: 250 mg InSea2® |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental area under the curve (iAUC, mmol*min/L) of blood glucose
Incremental area under the curve (iAUC, mmol*min/L)
Measured: 0, 15, 30, 45, 60, 75, 90, 120, 150, 180 and 210 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionApr 2017
- Study completion25 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood GlucoseStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- innoVactiv Inc.
- Responsible party
- Sponsor
- Investigators
- Peter Jones, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853916
- Sponsor's protocol ID
- B2016:51
- Status last verified
- Oct 2017
- First submitted
- 14 Jul 2016
- Last updated
- 26 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Brown Seaweed Powder for Glycemic Control
- ClinicalTrials.gov ID
- NCT02853916
- Acronym / sponsor ID
- B2016:51
- Conditions
- Blood Glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- innoVactiv Inc.
- Study start
- Aug 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- 25 Oct 2017 (actual)
- First posted
- 3 Aug 2016 (estimated)
- 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.
The objectives of this trial are to confirm efficacy in human of a brown seaweed powder and explore dose-response relationship by comparing two different doses.
The primary endpoint is incremental area under the curve (iAUC, mmol*min/L) for blood glucose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 500 mg InSea2® | Active comparator | Dietary Supplement: 500 mg InSea2® |
| 250 mg InSea2® | Active comparator | Dietary Supplement: 250 mg InSea2® |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males and females aged between 18-45 y
- Normoglycemic (fasting blood glucose <5.6 mmol/L)
- Body mass index (BMI) 18.5-29.9 kg/m2
- Able to consume bread products
Key exclusion criteria (12 listed)
- Fasting blood glucose > 5.6 mmol/L
- Systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg
- Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease
- Presence of a gastrointestinal disorder within the past year
- Presence of major gastrointestinal surgeries
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 |
|---|---|---|
| 500 mg InSea2® | Dietary supplement | 500 mg InSea2® |
| 250 mg InSea2® | Dietary supplement | 250 mg InSea2® |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Incremental area under the curve (iAUC, mmol*min/L) of blood glucose
Time frame: 0, 15, 30, 45, 60, 75, 90, 120, 150, 180 and 210 min
Incremental area under the curve (iAUC, mmol*min/L)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
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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.
Peter Jones, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 500 mg InSea2® and 250 mg InSea2® in people with Blood Glucose, run by University of Manitoba at 1 site in Canada.
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 4 inclusion and 12 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: finished, as of the sponsor's last update on 26 Oct 2017. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incremental area under the curve (iAUC, mmol*min/L) of blood glucose (time frame: 0, 15, 30, 45, 60, 75, 90, 120, 150, 180 and 210 min). 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 26 Oct 2017.