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NCT06081140
Tolerance and Palatability of 10-day Supplementation With Hemp Oil, Calamari Oil, and Broccoli Extract in Healthy Adults
NA trial testing Standard Process Hemp Oil Complex in Diet, Healthy in 14 participants. Completed in 26 May 2019.
26 May 2019
Quick facts
| Lead sponsor | Standard Process Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 14 |
| Start date | 26 April 2019 |
| Primary completion | 26 May 2019 |
| Estimated completion | 26 May 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Standard Process Hemp Oil Complex
Conditions studied
- Diet, Healthy — all drugs for Diet, Healthy →
Sponsor
Standard Process Inc.
Who can join
Adults 18 to 75, any sex, with Diet, Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06081140
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Standard Process Inc. trials
Trials by the same sponsor.
- NCT07371598 — Royal Ancient Oats™ Study · NA · recruiting
- NCT07373574 — Effects of Dietary Supplements on Nail and Hair Health · NA · not yet recruiting
- NCT06840574 — The Effect of Nutritional Supplementation on Actinic Purpura: A Pilot Study · NA · suspended
- NCT06795945 — A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Safety of a Bovine Thymus Nuclear Extract · NA · completed
- NCT05877365 — Effects of 21-day Purification Program on Healthy Adults · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06081140 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Standard Process Inc.
- Last refreshed: 13 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06081140.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing