NCT06081140

Tolerance and Palatability of 10-day Supplementation With Hemp Oil, Calamari Oil, and Broccoli Extract in Healthy Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Standard Process Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diet, Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Standard Process Hemp Oil Complex	10 days of supplementation to determine the tolerance and palatability of Standard Process Hemp Oil Complex.

Timeline

• Start date: 2019-04-26
• Primary completion: 2019-05-26
• Completion: 2019-05-26
• First posted: 2023-10-13
• Last updated: 2023-10-13

Locations

1 site across 1 country: United States