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Completed

NCT Number: NCT00936754

Safety and Efficacy of a Single Dose of a Polyphenol-enriched Brown Seaweed Powder in Human

The primary endpoint of this trial will be to evaluate the safety of a single administration in human of a dose of 500 mg of a polyphenol-rich algal powder when taken 30 minutes before a test meal. The secondary endpoint of this trial will be to evaluate if a single administration in human of a dose of 500 mg of a polyphenol-rich algal powder is able to reduce the rate of carbohydrate absorption as measured by following postprandial glycemia and insulinemia.

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Key information

Conditions

Glycemic Index

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Institut des Nutraceutiques et des Aliments Fonctionnels (INAF)

Québec, Quebec, G1V 0A6, Canada

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy volunteer
  • BMI between 20 and 30
  • Non-smoking

Exclusion criteria

  • Iodine allergy
  • Diabetes
  • Use of dietary supplements for duration of study
  • History of major surgeries or surgeries of the stomach or digestive tract

Treatment and study plan

Brown seaweed powder

Dietary Supplement

500 mg (in two 250 mg capsules) taken with 250 ml of water 30 minutes before test meal (110g of plain white bread with 250 ml of water)

Placebo

Dietary Supplement

Two capsules similar in aspect and weight to active product, taken with 250 ml of water 30 minutes before test meal (110g of plain white bread with 250 ml of water)

Primary outcomes

  1. Safety of a single 500 mg administration of a brown seaweed extract in human

    Time frame: First administration up to 7 days after last administration

Secondary outcomes

  1. Significant reduction of glycemic index of test food

    Time frame: Immediately after product administration (single use)

  2. Significant reduction in postprandial glycemia

    Time frame: Immediately after product administration (single use)

  3. Significant reduction in postprandial insulinemia

    Time frame: Immediately after product administration (single use)

Sponsors and collaborators

Lead sponsor

innoVactiv Inc.

Industry

Registry information

Official study title

Safety and Efficacy of a Unique Dose of a Brown Seaweeds Powder Enriched in Polyphenols on Human

Acronym: ICAST

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Jul 10, 2009
Registry last updated
Jan 20, 2010

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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