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

Sponsor

Standard Process Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT06081140

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Days)

14.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diet, Healthy	Dietary Supplement: Standard Process Hemp Oil Complex	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Apr 26, 2019

Actual Primary Completion Date :

May 26, 2019

Actual Study Completion Date :

May 26, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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