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Salba, Poppy, Flaxseed, Sesame, Wheat Bran

Phase 1

Cardiovascular Diseases | Unknown | Other |Unity Biotechnology, Inc.|Last Updated: Mar 7, 2014

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment21
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01579656Effect of Flax, Poppy, Sesame & Salba on Postprandial Blood Glucose Response, Vascular, Appetite & Sensory ParametersPHASE1 COMPLETED 21Feb 1, 2011Aug 1, 2012Mar 7, 20141 Canada
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Study Endpoints
Primary Endpoints
Postprandial Blood Glucose
3 hours

At each visit, postprandial blood glucose will be measured every 15 minutes over 3 hours.

Secondary Endpoints
Blood Pressure
3 hours
Arterial Stiffness
3 hours
Palatability
3 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposePREVENTION
Treatment Arms
ArmTypeDescription
SalbaEXPERIMENTAL25g of ground Salba baked into a bran muffin
PoppyEXPERIMENTAL25g of ground poppy seeds baked into a bran muffin
FlaxseedEXPERIMENTAL25g of ground flaxseed baked into a bran muffin
SesameEXPERIMENTAL25g of ground sesame seeds baked into a bran muffin
Wheat BranPLACEBO_COMPARATORBran muffin matched for total available carbohydrates, total dietary fibre and calories
Interventions
NameTypeDescription
SalbaDIETARY_SUPPLEMENT25g of ground Salba baked into a bran muffin matched for total available carbohydrate (50g), total dietary fibre (15g), and calories (494.5 kcal) with the addition of flour, inulin or canola oil. One of five muffins (Salba, Poppy, Sesame, Flax, Bran) will be administered at each visit.
PoppyDIETARY_SUPPLEMENT25g of ground Poppy Seeds baked into a bran muffin matched for total available carbohydrate (50g), total dietary fibre (15g), and calories (494.5 kcal) with the addition of flour, inulin or canola oil. One of five muffins (Salba, Poppy, Sesame, Flax, Bran) will be administered at each visit.
FlaxseedDIETARY_SUPPLEMENT25g of ground Flaxseed baked into a bran muffin matched for total available carbohydrate (50g), total dietary fibre (15g), and calories (494.5 kcal) with the addition of flour, inulin or canola oil. One of five muffins (Salba, Poppy, Sesame, Flax, Bran) will be administered at each visit.
SesameDIETARY_SUPPLEMENT25g of ground Sesame Seeds baked into a bran muffin matched for total available carbohydrate (50g), total dietary fibre (15g), and calories (494.5 kcal) with the addition of flour, inulin or canola oil. One of five muffins (Salba, Poppy, Sesame, Flax, Bran) will be administered at each visit.
Wheat BranDIETARY_SUPPLEMENTBran muffin matched for total available carbohydrate (50g), total dietary fibre (15g), and calories (494.5 kcal). One of five muffins (Salba, Poppy, Sesame, Flax, Bran) will be administered at each visit.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * age 18-65 years * normal glycemic response * BMI between 18.5 - 25 kg/m2 * peripheral systolic and diastolic blood pressure \< 140mmHg and \< 90mmHg Exclusion Criteria: * known history of liver or kidney disease, diabetes, hypertension, stroke or myocardial infarctions, thyr...

Countries:Canada
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