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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00936754
Acronym
ICAST
Enrollment
23
Registered
2009-07-10
Start date
2009-07-31
Completion date
2010-01-31
Last updated
2010-01-20

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

Conditions

Glycemic Index

Keywords

Glycemic index, Reduction of glycemic index of ingested foods

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTBrown seaweed powder

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)

DIETARY_SUPPLEMENTPlacebo

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)

Sponsors

innoVactiv Inc.
Lead SponsorINDUSTRY

Study design

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Safety of a single 500 mg administration of a brown seaweed extract in humanFirst administration up to 7 days after last administration

Secondary

MeasureTime frame
Significant reduction of glycemic index of test foodImmediately after product administration (single use)
Significant reduction in postprandial glycemiaImmediately after product administration (single use)
Significant reduction in postprandial insulinemiaImmediately after product administration (single use)

Countries

Canada

Outcome results

None listed

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