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

NCT01384110 | Completed Phase 1

• 1 other identifier: 2010-RD-01-CLN
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperglycemia

Keywords

Amylase; Glucosidase; Glycemic response; Sucrose; Seaweed

Outcome Measures

Primary Outcomes (2)

• Significant reduction in postprandial glycemia

  Immediately after product administration (single use)

• Significant reduction in postprandial insulinemia

  Immediately after product administration (single use)

Secondary Outcomes (1)

• Frequency and severity of Adverse Events as a Measure of Safety and Tolerability

  First administration up to 7 days after last administration

Study Arms (2)

Brown Seaweed Lemon Tea

EXPERIMENTAL

Single administration of lemon tea containing 500 mg of brown seaweed powder and 50 g of sucrose

Dietary Supplement: Reduction of glycemic index of ingested foods

Placebo lemon tea

PLACEBO COMPARATOR

Single administration of placebo lemon tea containing 50 g of sucrose

Dietary Supplement: Reduction of glycemic index of ingested foods

Interventions

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.

Also known as: InSea2

Brown Seaweed Lemon Tea; Placebo lemon tea

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• innoVactiv Inc.: lead

Study Sites (1)

Institut des Nutraceutiques et des Aliments Fonctionnels (INAF)

Québec, Quebec, Canada

Location

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2011
• First Posted: June 28, 2011
• Study Start: June 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 15, 2011

Record last verified: 2011-11

Locations

CA (1)