Diet, Healthy
Conditions
Keywords
whole food, botanical, dietary supplement, bioactive components, antioxidants, hemp oil complex, ECS, Nutrition
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTStandard Process Hemp Oil Complex
10 days of supplementation to determine the tolerance and palatability of Standard Process Hemp Oil Complex.
Sponsors
Standard Process Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject is between 18 and 75 years old * Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit, and is not actively planning a pregnancy * If on a chronic medication (that does not result in exclusion), subject has been on stable dose for at least two months prior to screening visit * Subject has at least two week wash out period between completion of a previous research study that required ingestion of any study food or drug, and their start in the current study * No allergy to any study products * Willingness to comply with study protocol for 10 days
Exclusion criteria
* Subjects who are experiencing any adverse events due to any nutraceutical, OTC, pharmaceutical, or investigational products * Subjects may not receive any other investigational products not part of normal clinical care * Lipid lowering drugs or the use of anticoagulant medications in the preceding 4 weeks and for duration of trial * Subjects with untreated endocrine, neurological, or infectious disease * Subjects with a current diagnosis or personal history of: significant liver or kidney disease, autoimmune disorders, deep vein thrombosis, history of cancer * Serious medical illness including a history of attempted suicide * Use of ethanol within 24 hours of the evaluation visits (baseline, and end of the study visit * Do not comply with the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerance | 10 days | gastrointestinal and general health measured by daily questionnaire, this is a numbered scale from 1-9 from the Global Quality of Life scale |
| palatability | 10 days | palatability of Standard Process Hemp Oil Complex by questionnaire scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxidative Stress Biomarkers | 1 month | Peripheral blood mononuclear cells were collected by venous blood draw and measured at baseline and end of study. |
| Liver Enzymes | 1 month | Liver enzymes were collected by venous blood draw and measured at baseline and end of study. |
| Medical Symptom Questionnaire (MSQ) | 10 days | MSQ scores were collected and measured at base line and end of the study- on a scale of 1-6 |
Countries
United States
Outcome results
None listed