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Salba, Flax, Control

Phase 1

Hyperglycemia, Postprandial | Unknown | Other |Unity Biotechnology, Inc.|Last Updated: Dec 3, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment15
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02621307Effect of Salba & Flax on Postprandial Glycemia and Subjective SatietyPHASE1 COMPLETED 15Jul 1, 2010Jul 1, 2011Dec 3, 20151 Canada
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Study Endpoints
Primary Endpoints
Change in Postprandial Blood Glucose
2 Hours

At each visit, postprandial blood glucose will be measured via capillary blood samples, at 15, 30, 45, 60, 90, and 120 minutes after intake of test meals

Secondary Endpoints
Change in Subjective Satiety
2 Hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposePREVENTION
Treatment Arms
ArmTypeDescription
SalbaEXPERIMENTAL50g glucose 25g ground Salba (Salba Corporation Ltd, Buenos Aires, Argentina) 200ml water
FlaxEXPERIMENTAL50g glucose 31g ground Flax (Bob's Red Mill Natural Raw Whole Flaxseed) 200ml water
ControlPLACEBO_COMPARATOR50g glucose 200ml water
Interventions
NameTypeDescription
SalbaDIETARY_SUPPLEMENT -
FlaxDIETARY_SUPPLEMENT -
ControlDIETARY_SUPPLEMENT -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * BMI less than 35 kg/m\^2 Exclusion Criteria: * known history of liver or kidney disease, diabetes, hypertension, stroke, or myocardial infarctions, thyroid disease, gastrointestinal disease, or AIDS * subjects using medications or Natural Health Products

Countries:Canada
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