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

NCT ID: NCT06081140

Last Updated: 2023-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-26
• Study Completion Date: 2019-05-26

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.

Conditions

Diet, Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Supplementation

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.

Group Type: EXPERIMENTAL

Standard Process Hemp Oil Complex

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Standard Process Hemp Oil Complex

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Standard Process Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Standard Process Nutrition Innovation Center

Kannapolis, North Carolina, United States

Countries

United States

Other Identifiers

Pro00032041

Identifier Type: -

Identifier Source: org_study_id