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Efficacy of a Brown Seaweed Powder for Glycemic Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02853916
Recruitment Status : Completed
First Posted : August 3, 2016
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
innoVactiv Inc.
Information provided by (Responsible Party):
University of Manitoba

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.


Condition or disease Intervention/treatment Phase
Blood Glucose Dietary Supplement: 500 mg InSea2® Dietary Supplement: 250 mg InSea2® Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of a Brown Seaweed Powder for Glycemic Control
Study Start Date : August 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : October 25, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Active Comparator: 500 mg InSea2® Dietary Supplement: 500 mg InSea2®
Active Comparator: 250 mg InSea2® Dietary Supplement: 250 mg InSea2®
Placebo Comparator: Placebo Dietary Supplement: Placebo



Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02853916


Locations
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Canada, Manitoba
Richardson Centre for Functional Foods and Nutraceuticals
Winnipeg, Manitoba, Canada, R3T 2N2
Sponsors and Collaborators
University of Manitoba
innoVactiv Inc.
Investigators
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Principal Investigator: Peter Jones, PhD University of Manitoba

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Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT02853916    
Other Study ID Numbers: B2016:51
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017