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

innoVactiv

Status and phase: Completed; Phase 1

Conditions: Glycemic Index

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Brown seaweed powder

Study type: Interventional

Funder types: Industry

Identifiers

NCT00936754

2005-RD-10-CLN2

Details and patient eligibility

About

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.

Enrollment: 23 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

23 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

Description:

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

Treatment:

Dietary Supplement: Brown seaweed powder

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo