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CompletedNCT02853916Updated Oct 26, 2017

Efficacy of a Brown Seaweed Powder for Glycemic Control

An interventional study of 500 mg InSea2® and 250 mg InSea2® in Blood Glucose, sponsored by University of Manitoba. Completed at 1 site in Canada. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-26.

Sponsored by University of Manitoba · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Blood Glucose
03

In context

Lead sponsor

University of Manitoba is the lead sponsor of 542 studies on the registry; 87 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
22 participants (actual)

Study arms

  • Active comparator
    500 mg InSea2®

    Dietary Supplement: 500 mg InSea2®

  • Active comparator
    250 mg InSea2®

    Dietary Supplement: 250 mg InSea2®

  • Placebo comparator
    Placebo

    Dietary Supplement: Placebo

Interventions

  • Dietary supplement500 mg InSea2®
  • Dietary supplement250 mg InSea2®
  • Dietary supplementPlacebo
06

What researchers measure

Primary outcomes

  1. Incremental area under the curve (iAUC, mmol*min/L) of blood glucose

    Incremental area under the curve (iAUC, mmol\*min/L)

    Time frame: 0, 15, 30, 45, 60, 75, 90, 120, 150, 180 and 210 min

07

Study locations

1 site
  • Richardson Centre for Functional Foods and Nutraceuticals
    Winnipeg, Manitoba R3T 2N2, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02853916
Lead sponsor
University of Manitoba
Collaborators
innoVactiv Inc.
Responsible party
Sponsor
First posted
Aug 3, 2016
Start date
Aug 2016
Primary completion
Apr 2017
Completion
Oct 25, 2017
Last update
Oct 26, 2017

Study contacts

Peter Jones, PhD
principal investigator · University of Manitoba
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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