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Efficacy of a Brown Seaweed Powder for Glycemic Control

U

University of Manitoba

Status

Completed

Conditions

Blood Glucose

Treatments

Dietary Supplement: 250 mg InSea2®
Dietary Supplement: Placebo
Dietary Supplement: 500 mg InSea2®

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02853916
B2016:51

Details and patient eligibility

About

The objectives of this trial are to confirm efficacy in human of a brown seaweed powder and explore dose-response relationship by comparing two different doses.

The primary endpoint is incremental area under the curve (iAUC, mmol*min/L) for blood glucose.

Enrollment

22 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Males and females aged between 18-45 y
  • Normoglycemic (fasting blood glucose <5.6 mmol/L)
  • Body mass index (BMI) 18.5-29.9 kg/m2
  • Able to consume bread products

Exclusion Criteria

  • Fasting blood glucose > 5.6 mmol/L
  • Systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg
  • Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease
  • Presence of a gastrointestinal disorder within the past year
  • Presence of major gastrointestinal surgeries
  • Thyroid problems
  • Smokers
  • Consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect blood glucose or that could affect the outcome of the study as per investigator's judgement
  • Women that are currently pregnant or lactating, or not using an appropriate contraception method
  • Excessive alcohol intake (more than 2 drinks per day or more than 9 drinks per week)
  • Allergic to shellfish (crab) or molluscs
  • Weight gain or loss of at least 10lbs in previous three months

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

22 participants in 3 patient groups, including a placebo group

500 mg InSea2®
Active Comparator group
Treatment:
Dietary Supplement: 500 mg InSea2®
250 mg InSea2®
Active Comparator group
Treatment:
Dietary Supplement: 250 mg InSea2®
Placebo
Placebo Comparator group
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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