Tolerance and palatability of short-term supplementation with a whole-food dietary formulation based on hemp oil, calamari oil, and broccoli was evaluated in healthy adults. This was a 10-day open-label, prospective, controlled trial (n=14) in which participants acted as their own controls to receive daily intervention standardized to contain 15 mg phytocannabinoids, 230 mg omega-3 fatty acids, and 5 mg glucoraphanin. The primary objective was to evaluate gastrointestinal tolerability and acceptability. The study demonstrated that daily ingestion of the investigational product was well tolerated with no or minor adverse events, and a good palatability. The secondary objectives were to access parameters of blood biochemistry, liver enzymes, biomarkers of immune and oxi-dative health, as well as phytocannabinoid profiles in urine.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
14
10 days of supplementation to determine the tolerance and palatability of Standard Process Hemp Oil Complex.
Standard Process Nutrition Innovation Center
Kannapolis, North Carolina, United States
Tolerance
gastrointestinal and general health measured by daily questionnaire, this is a numbered scale from 1-9 from the Global Quality of Life scale
Time frame: 10 days
palatability
palatability of Standard Process Hemp Oil Complex by questionnaire scale.
Time frame: 10 days
Oxidative Stress Biomarkers
Peripheral blood mononuclear cells were collected by venous blood draw and measured at baseline and end of study.
Time frame: 1 month
Liver Enzymes
Liver enzymes were collected by venous blood draw and measured at baseline and end of study.
Time frame: 1 month
Medical Symptom Questionnaire (MSQ)
MSQ scores were collected and measured at base line and end of the study- on a scale of 1-6
Time frame: 10 days
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