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OpenTrials
Completed

NCT Number: NCT01384110

Efficacy of a Brown Seaweed Extract Rich in Polyphenols on Glycemic Response to Sucrose in Human

The primary endpoint of this trial will be to evaluate if a single administration in human of a lemon ice tea containing 500 mg of a polyphenol-rich algal powder is able to reduce postprandial glycemia and insulinemia.

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Key information

Conditions

Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

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, Canada

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy volunteer aged 18 to 60
  • BMI between 20 and 30
  • Non-smoking
  • Using valid contraceptive method (women of childbearing age)

Exclusion criteria

  • Iodine allergy, or allergy to components of the test product or placebo or standard meal
  • Diabetes
  • Use of dietary supplements for duration of study
  • History of gastro-intestinal affections, anemia, major surgeries or surgeries of the stomach or digestive tract

Treatment and study plan

Reduction of glycemic index of ingested foods

Dietary Supplement

Oral administration of the experimental lemon tea powder(56.1 g) and the placebo lemon tea powder (55.6 g) dissolved in water. Each participant will receive both treatment in a cross-over protocol design during 2 visits separated by a 2-weeks period. The day before both intervention, participants will consume a standardised meal for the supper.

Other names: InSea2

Primary outcomes

  1. Significant reduction in postprandial glycemia

    Time frame: Immediately after product administration (single use)

  2. Significant reduction in postprandial insulinemia

    Time frame: Immediately after product administration (single use)

Secondary outcomes

  1. Frequency and severity of Adverse Events as a Measure of Safety and Tolerability

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

Sponsors and collaborators

Lead sponsor

innoVactiv Inc.

Industry

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 28, 2011
Registry last updated
Nov 15, 2011

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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