NCT00936754

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 10, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

January 20, 2010

Status Verified

January 1, 2010

Enrollment Period

4 months

First QC Date

July 9, 2009

Last Update Submit

January 18, 2010

Conditions

Glycemic Index

Keywords

Glycemic indexReduction of glycemic index of ingested foods

Outcome Measures

Primary Outcomes (1)

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

    First administration up to 7 days after last administration

Secondary Outcomes (3)

  • Significant reduction of glycemic index of test food

    Immediately after product administration (single use)

  • Significant reduction in postprandial glycemia

    Immediately after product administration (single use)

  • Significant reduction in postprandial insulinemia

    Immediately after product administration (single use)

Study Arms (2)

Treatment

EXPERIMENTAL

Single administration of 500 mg of encapsulated brown seaweed powder, taken 30 minutes before test meal

Dietary Supplement: Brown seaweed powder

Placebo

PLACEBO COMPARATOR

Single administration of encapsulated placebo, taken 30 minutes before test meal

Dietary Supplement: Placebo

Interventions

Brown seaweed powderDIETARY_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)

Treatment
PlaceboDIETARY_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)

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut des Nutraceutiques et des Aliments Fonctionnels (INAF)

Québec, Quebec, G1V 0A6, Canada

Location

Study Officials

  • Patrick Couture, MD, PhD

    Institut des nutraceutiques et des aliments fonctionnels

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 9, 2009

First Posted

July 10, 2009

Study Start

July 1, 2009

Primary Completion

November 1, 2009

Study Completion

January 1, 2010

Last Updated

January 20, 2010

Record last verified: 2010-01

Locations

CA(1)