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

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.

Study Overview

• Status: Completed
• Conditions: Diet, Healthy
• Intervention / Treatment: Dietary supplement: Standard Process Hemp Oil Complex

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Kannapolis, North Carolina, United States, 28081
      • Standard Process Nutrition Innovation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Standard Process Hemp Oil Complex; 10 days of supplementation to determine the tolerance and palatability of Standard Process Hemp Oil Complex.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerance	gastrointestinal and general health measured by daily questionnaire, this is a numbered scale from 1-9 from the Global Quality of Life scale	10 days
palatability	palatability of Standard Process Hemp Oil Complex by questionnaire scale.	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxidative Stress Biomarkers	Peripheral blood mononuclear cells were collected by venous blood draw and measured at baseline and end of study.	1 month
Liver Enzymes	Liver enzymes were collected by venous blood draw and measured at baseline and end of study.	1 month
Medical Symptom Questionnaire (MSQ)	MSQ scores were collected and measured at base line and end of the study- on a scale of 1-6	10 days

Collaborators and Investigators

• Sponsor: Standard Process Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2019
• Primary Completion (Actual): May 26, 2019
• Study Completion (Actual): May 26, 2019

Study Registration Dates

• First Submitted: September 25, 2023
• First Submitted That Met QC Criteria: October 9, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Nutrition; dietary supplement; antioxidants; botanical; ECS; whole food; bioactive components; hemp oil complex
• Other Study ID Numbers: Pro00032041

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No