Efficacy of a Brown Seaweed Powder for Glycemic Control | NCT02853916

Studies
Efficacy of a Brown Seaweed Powder for Glycemic Control

NCT02853916

Sponsor

University of Manitoba

Status

Completed

Last Update Posted

Oct 26, 2017Actual

Enrollment

22Actual

Phase

Not Applicable

Conditions

Blood Glucose

Interventions

500 mg InSea2®
250 mg InSea2®
Placebo

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2016

Primary Completion Date

Apr 2017Actual

Completion Date

Oct 25, 2017Actual

First Submitted Date

Jul 14, 2016

First Submission Date that Met QC Criteria

Jul 29, 2016

First Posted Date

Aug 3, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2017

Last Update Posted Date

Oct 26, 2017Actual

Name	Class
innoVactiv Inc.	INDUSTRY

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
500 mg InSea2®	Active Comparator	Dietary Supplement: 500 mg InSea2®
250 mg InSea2®	Active Comparator	Dietary Supplement: 250 mg InSea2®
Placebo	Placebo Comparator	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
500 mg InSea2®	Dietary Supplement		500 mg InSea2®
250 mg InSea2®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incremental area under the curve (iAUC, mmol*min/L) of blood glucose	Incremental area under the curve (iAUC, mmol*min/L)	0, 15, 30, 45, 60, 75, 90, 120, 150, 180 and 210 min

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Jones, PhD	University of Manitoba	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Richardson Centre for Functional Foods and Nutraceuticals		Winnipeg	Manitoba	R3T 2N2	Canada