Efficacy of a Brown Seaweed Powder for Glycemic Control
1 other identifier
interventional
22
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedFirst Posted
Study publicly available on registry
August 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 25, 2017
CompletedOctober 26, 2017
October 1, 2017
8 months
July 14, 2016
October 25, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Incremental area under the curve (iAUC, mmol*min/L) of blood glucose
Incremental area under the curve (iAUC, mmol\*min/L)
0, 15, 30, 45, 60, 75, 90, 120, 150, 180 and 210 min
Study Arms (3)
500 mg InSea2®
ACTIVE COMPARATOR250 mg InSea2®
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Manitobalead
- innoVactiv Inc.collaborator
Study Sites (1)
Richardson Centre for Functional Foods and Nutraceuticals
Winnipeg, Manitoba, R3T 2N2, Canada
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Jones, PhD
University of Manitoba
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2016
First Posted
August 3, 2016
Study Start
August 1, 2016
Primary Completion
April 1, 2017
Study Completion
October 25, 2017
Last Updated
October 26, 2017
Record last verified: 2017-10