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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01384110
Enrollment
43
Registered
2011-06-28
Start date
2011-06-30
Completion date
2011-10-31
Last updated
2011-11-15

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

Conditions

Hyperglycemia

Keywords

Amylase, Glucosidase, Glycemic response, Sucrose, Seaweed

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.

Interventions

DIETARY_SUPPLEMENTReduction of glycemic index of ingested foods

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.

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 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

Design outcomes

Primary

MeasureTime frame
Significant reduction in postprandial glycemiaImmediately after product administration (single use)
Significant reduction in postprandial insulinemiaImmediately after product administration (single use)

Secondary

MeasureTime frame
Frequency and severity of Adverse Events as a Measure of Safety and TolerabilityFirst administration up to 7 days after last administration

Countries

Canada

Outcome results

None listed

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