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

NCT06081140 | Completed

• 1 other identifier: Pro00032041
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Keywords

whole food; botanical; dietary supplement; bioactive components; antioxidants; hemp oil complex; ECS; Nutrition

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Oxidative Stress Biomarkers

  1 month

• Liver Enzymes

  1 month

• Medical Symptom Questionnaire (MSQ)

  10 days

Study Arms (1)

Supplementation

EXPERIMENTAL

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

Interventions

Standard Process Hemp Oil Complex DIETARY_SUPPLEMENT

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

Supplementation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Standard Process Inc.: lead

Study Sites (1)

Standard Process Nutrition Innovation Center

Kannapolis, North Carolina, 28081, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 13, 2023
• Study Start: April 26, 2019
• Primary Completion: May 26, 2019
• Study Completion: May 26, 2019
• Last Updated: October 13, 2023

Record last verified: 2023-10

Locations

US (1)