Efficacy of a Brown Seaweed Powder for Glycemic Control
NCT ID: NCT02853916
Last Updated: 2017-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
22 participants
INTERVENTIONAL
2016-08-31
2017-10-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The primary endpoint is incremental area under the curve (iAUC, mmol\*min/L) for blood glucose.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
500 mg InSea2®
500 mg InSea2®
250 mg InSea2®
250 mg InSea2®
Placebo
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
500 mg InSea2®
250 mg InSea2®
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Normoglycemic (fasting blood glucose \<5.6 mmol/L)
* Body mass index (BMI) 18.5-29.9 kg/m2
* Able to consume bread products
Exclusion Criteria
* 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
* 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
18 Years
45 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
innoVactiv Inc.
INDUSTRY
University of Manitoba
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Peter Jones, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Manitoba
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Richardson Centre for Functional Foods and Nutraceuticals
Winnipeg, Manitoba, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
B2016:51
Identifier Type: -
Identifier Source: org_study_id