Diet, HealthyNCT06081140
Tolerance and Palatability of 10-day Supplementation With Hemp Oil, Calamari Oil, and Broccoli Extract in Healthy Adults
A study testing Standard Process Hemp Oil Complex in people with Diet, Healthy, run by Standard Process Inc. at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy
- What is being tested?
- Standard Process Hemp Oil Complex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2019to 26 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Standard Process Nutrition Innovation Center
Kannapolis, North Carolina, 28081
About this study
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
- Being tested
- Standard Process Hemp Oil Complex
- Keywords
- whole food, botanical, dietary supplement, bioactive components, antioxidants, hemp oil complex, ECS, Nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Process Hemp Oil ComplexDietary supplement
10 days of supplementation to determine the tolerance and palatability of Standard Process Hemp Oil Complex.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Standard Process Hemp Oil Complex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance
gastrointestinal and general health measured by daily questionnaire, this is a numbered scale from 1-9 from the Global Quality of Life scale
Measured: 10 days
palatability
palatability of Standard Process Hemp Oil Complex by questionnaire scale.
Measured: 10 days
Secondary outcomes (3)
Oxidative Stress Biomarkers
Peripheral blood mononuclear cells were collected by venous blood draw and measured at baseline and end of study.
Measured: 1 month
Liver Enzymes
Liver enzymes were collected by venous blood draw and measured at baseline and end of study.
Measured: 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
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start26 Apr 2019
- Primary completion26 May 2019
- Study completion26 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Standard Process Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081140
- Sponsor's protocol ID
- Pro00032041
- Status last verified
- Oct 2023
- First submitted
- 25 Sep 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance and Palatability of 10-day Supplementation With Hemp Oil, Calamari Oil, and Broccoli Extract in Healthy Adults
- ClinicalTrials.gov ID
- NCT06081140
- Acronym / sponsor ID
- Pro00032041
- Conditions
- Diet, Healthy
- Keywords
- whole food, botanical, dietary supplement, bioactive components, antioxidants, hemp oil complex, ECS, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Standard Process Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- 26 May 2019 (actual)
- Study completion
- 26 May 2019 (actual)
- First posted
- 13 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supplementation | Experimental | Dietary Supplement: Standard Process Hemp Oil ComplexParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Process Hemp Oil Complex10 days of supplementation to determine the tolerance and palatability of Standard Process Hemp Oil Complex. | Dietary supplement | Supplementation |
Primary outcome
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
palatability
Time frame: 10 days
palatability of Standard Process Hemp Oil Complex by questionnaire scale.
3 secondary outcomes
Oxidative Stress Biomarkers
Time frame: 1 month
Liver Enzymes
Time frame: 1 month
Medical Symptom Questionnaire (MSQ)
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Process Hemp Oil Complex in people with Diet, Healthy, run by Standard Process Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance (time frame: 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.