Efficacy of a Brown Seaweed Powder for Glycemic Control

University of Manitoba

Status: Completed

Conditions: Blood Glucose

Treatments: Dietary Supplement: 250 mg InSea2®; Dietary Supplement: Placebo; Dietary Supplement: 500 mg InSea2®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02853916

B2016:51

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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22 participants in 3 patient groups, including a placebo group

500 mg InSea2®

Active Comparator group

Treatment:

Dietary Supplement: 500 mg InSea2®

250 mg InSea2®

Active Comparator group

Treatment:

Dietary Supplement: 250 mg InSea2®

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo