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Completed

NCT Number: NCT06081140

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.

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Key information

Conditions

Diet, Healthy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Standard Process Nutrition Innovation Center

Kannapolis, North Carolina, 28081, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Process Hemp Oil Complex

Dietary Supplement

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

Primary outcomes

  1. Tolerance

    Time frame: 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

  2. palatability

    Time frame: 10 days

    palatability of Standard Process Hemp Oil Complex by questionnaire scale.

Secondary outcomes

  1. Oxidative Stress Biomarkers

    Time frame: 1 month

    Peripheral blood mononuclear cells were collected by venous blood draw and measured at baseline and end of study.

  2. Liver Enzymes

    Time frame: 1 month

    Liver enzymes were collected by venous blood draw and measured at baseline and end of study.

  3. Medical Symptom Questionnaire (MSQ)

    Time frame: 10 days

    MSQ scores were collected and measured at base line and end of the study- on a scale of 1-6

Sponsors and collaborators

Lead sponsor

Standard Process Inc.

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 13, 2023
Registry last updated
Oct 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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