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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supplementation | Experimental | Participants were enrolled at baseline where all outcome measures were collected. Once baseline visit was complete, participants started with the supplementation of Hemp Oil Complex by Standard Process. After 10 days, outcome measures were collected. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Process Hemp Oil Complex | Dietary Supplement | 10 days of supplementation to determine the tolerance and palatability of Standard Process Hemp Oil Complex. |
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| Measure | Description | Time Frame |
|---|---|---|
| Tolerance | gastrointestinal and general health measured by daily questionnaire, this is a numbered scale from 1-9 from the Global Quality of Life scale | 10 days |
| palatability | palatability of Standard Process Hemp Oil Complex by questionnaire scale. | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Oxidative Stress Biomarkers | Peripheral blood mononuclear cells were collected by venous blood draw and measured at baseline and end of study. | 1 month |
| Liver Enzymes | Liver enzymes were collected by venous blood draw and measured at baseline and end of study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Standard Process Nutrition Innovation Center | Kannapolis | North Carolina | 28081 | United States |
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| 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 | 10 days |