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

Diet, Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06081140
• Other study ID #: Pro00032041
• Status: Completed
• Phase: N/A
• Start date: April 26, 2019
• Est. completion date: May 26, 2019

Study information

• Verified date: October 2023
• Source: Standard Process Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 26, 2019
• Est. primary completion date: May 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet, Healthy

Intervention

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

Locations

Country	Name	City	State
United States	Standard Process Nutrition Innovation Center	Kannapolis	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Standard Process Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	palatability	palatability of Standard Process Hemp Oil Complex by questionnaire scale.	10 days
Secondary	Oxidative Stress Biomarkers	Peripheral blood mononuclear cells were collected by venous blood draw and measured at baseline and end of study.	1 month
Secondary	Liver Enzymes	Liver enzymes were collected by venous blood draw and measured at baseline and end of study.	1 month
Secondary	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