Status:
COMPLETED
Tolerance and Palatability of 10-day Supplementation With Hemp Oil, Calamari Oil, and Broccoli Extract in Healthy Adults
Lead Sponsor:
Standard Process Inc.
Conditions:
Diet, Healthy
Eligibility:
All Genders
18-75 years
Phase:
NA
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-lab...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2019
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06081140
Start Date
April 26 2019
End Date
May 26 2019
Last Update
October 13 2023
Active Locations (1)
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1
Standard Process Nutrition Innovation Center
Kannapolis, North Carolina, United States, 28081