Efficacy of a Brown Seaweed Powder for Glycemic Control

Blood Glucose Clinical Trial

Official title:

Efficacy of a Brown Seaweed Powder for Glycemic Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02853916
• Other study ID #: B2016:51
• Status: Completed
• Phase: N/A
• First received: July 14, 2016
• Last updated: October 25, 2017
• Start date: August 2016
• Est. completion date: October 25, 2017

Study information

• Verified date: October 2017
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 25, 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Glucose

Intervention

Dietary Supplement:
• 500 mg InSea2®

• 250 mg InSea2®

• Placebo

Locations

Country	Name	City	State
Canada	Richardson Centre for Functional Foods and Nutraceuticals	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	innoVactiv Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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