Efficacy of a Brown Seaweed Powder for Glycemic Control

Not Applicable

Completed

• Conditions: Blood Glucose
• Interventions: Dietary Supplement: 250 mg InSea2®; Dietary Supplement: Placebo; Dietary Supplement: 500 mg InSea2®

• Registration Number: NCT02853916
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2016-07-14
• Study First Submitted QC: 2016-07-29
• Study Start: 2016-08
• Study First Posted: 2016-08-03
• Primary Completion: 2017-04
• Status Verified: 2017-10
• Study Completion: 2017-10-25
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
250 mg InSea2®	250 mg InSea2®	-
Placebo	Placebo	-
500 mg InSea2®	500 mg InSea2®	-

Primary Outcome Measures

Name	Time	Method
Incremental area under the curve (iAUC, mmol*min/L) of blood glucose	0, 15, 30, 45, 60, 75, 90, 120, 150, 180 and 210 min	Incremental area under the curve (iAUC, mmol\*min/L)

Trial Locations

Locations (1)

Richardson Centre for Functional Foods and Nutraceuticals; 🇨🇦 Winnipeg, Manitoba, Canada