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Efficacy of a Brown Seaweed Powder for Glycemic Control

Efficacy of a Brown Seaweed Powder for Glycemic Control

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02853916
Enrollment
22
Registered
2016-08-03
Start date
2016-08-31
Completion date
2017-10-25
Last updated
2017-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Glucose

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.

Interventions

DIETARY_SUPPLEMENT500 mg InSea2®
DIETARY_SUPPLEMENT250 mg InSea2®
DIETARY_SUPPLEMENTPlacebo

Sponsors

innoVactiv Inc.
CollaboratorINDUSTRY
University of Manitoba
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incremental area under the curve (iAUC, mmol*min/L) of blood glucose0, 15, 30, 45, 60, 75, 90, 120, 150, 180 and 210 minIncremental area under the curve (iAUC, mmol\*min/L)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026