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OpenTrials
Completed

NCT Number: NCT02853916

Efficacy of a Brown Seaweed Powder for Glycemic Control

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Richardson Centre for Functional Foods and Nutraceuticals

Winnipeg, Manitoba, R3T 2N2, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

500 mg InSea2®

Dietary Supplement

250 mg InSea2®

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

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

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

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

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • innoVactiv Inc.

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 3, 2016
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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