Efficacy of a Brown Seaweed Powder for Glycemic Control

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 Overview

• Status: Completed
• Conditions: Blood Glucose
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: 500 mg InSea2®; Dietary supplement: 250 mg InSea2®

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3T 2N2
      • Richardson Centre for Functional Foods and Nutraceuticals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo
Active Comparator: 500 mg InSea2®	Dietary supplement: 500 mg InSea2®
Active Comparator: 250 mg InSea2®	Dietary supplement: 250 mg InSea2®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: innoVactiv Inc.
• Investigators: Principal Investigator: Peter Jones, PhD, University of Manitoba

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): October 25, 2017

Study Registration Dates

• First Submitted: July 14, 2016
• First Submitted That Met QC Criteria: July 29, 2016
• First Posted (Estimate): August 3, 2016

Study Record Updates

• Last Update Posted (Actual): October 26, 2017
• Last Update Submitted That Met QC Criteria: October 25, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: B2016:51