SleepNCT04294706
Effects of Hemp Oil on Markers of Optimal Wellness, Stress Resilience and Recovery in Healthy Subjects
A study testing Hemp arm in people with Sleep and Stress, run by The Center for Applied Health Sciences, LLC at 1 site in United States.
Trial summary
The purpose of this placebo-controlled, double-blind study is to determine the effects of a commercially available (i.e. dietary supplement) Hemp Oil Extract product on various markers of physical and mental stress resilience, and perceived recovery from normal daily physical \& mental stress. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- What is being tested?
- Hemp arm
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2018to 29 Aug 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects provide written and dated informed consent to participate in an IRB approved study.
- Subjects are in good health as determined by medical history and routine blood chemistries.
- Subjects are male or female between the ages of 18 and 55 (inclusive).
- Female subjects must agree to use barrier contraceptive methods during sexual intercourse for the duration of the study. All females will undergo pregnancy testing (urine HCG screen) before being screened and at each visit unless they present evidence of surgical sterilization by tubal ligation, bilateral oophorectomy or hysterectomy.
- Subjects have a Body Mass Index of 25-35.
- Subjects are willing and able to comply with the daily activity and supplement protocol.
- Subject is willing and able to comply with the visit schedule.
- Subjects are normotensive (resting systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg), have a normal resting heart rate (<90 per minute).
Who cannot join
- Subjects that currently exercise more than three times per week.
- Subject has used weight loss medications within the past three months of Screening visit.
- Subject is on thyroid medication at a dose that is not considered stable. Stable is defined as using the same dose consistently for at least 90 days.
- Subjects with any metabolic disorder including known electrolyte abnormalities, diabetes (or fasting glucose ≥126 mg/dL at the screening visit), unstable or unmanaged thyroid disease, or hypogonadism.
- Subjects with a history of hepato-renal, musculoskeletal, autoimmune, neurologic disease, or any other medical condition deemed exclusionary by the medical staff.
- Subjects taking anti-anxiety, anti-depressant, psychotropic hyperlipidemic, hypoglycemic, anti-coagulant or androgenic medications; nitrates/nitrate derivatives, and PDE-5 inhibitors; and other vasodilatory agents such as calcium channel blockers and beta blockers.
Show all 23Show fewer
- Subject has an active gastrointestinal disorder such as peptic ulcer disease or malabsorption syndrome (mild lactose intolerance or gastroesophageal reflux diseases are acceptable).
- Subjects who have taken anabolic steroids, growth hormone, IGF-1 or other anabolic drugs within the past year.
- Subjects who are pregnant, trying to become pregnant, or who are nursing.
- Female participants who are < 120 days postpartum before enrolling.
- Subjects who have taken any nutritional supplements that may affect sleep, mood or healthy stress response (including but not limited to Ashwagandha, Valerian root, Melatonin, L-theanine, 5-HTP), or that may affect anabolic/catabolic hormone levels (e.g., androstenedione, DHEA, etc.) within four weeks prior to the start of the study.
- Subjects who have gained or lost more than 5 lbs within 30 days prior to the start of the study.
- Subjects with history of heart disease, peripheral vascular disorders or vaso-occlusive or vasospastic syndromes, psychiatric disorders, or history of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin.
- Subject has a recent history of (within 3 months of Screening Visit) or strong potential for alcohol or substance abuse. Alcohol abuse defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
- Subject has been hospitalized within the past one-year for any mental or emotional illness.
- Subject has an active infection or sign/symptoms of an infection.
- Subject has dietary tendencies that may be representative of disordered eating (in the opinion of the Investigator).
- Subjects who had any known allergy to any of the ingredients in any of the test products.
- Subjects who are participating in other research studies.
- Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.
- Subjects who smoked or used any tobacco or nicotine containing products within the past year.
- Subjects with syndromes or prescribed medications that may influence body composition, or CVD (e.g. prednisone, Ritalin, Adderall, GH); also protease inhibitors/antivirals (nucleic acid analogs).
- Subjects with orthopedic limitations or injuries that would preclude them from the physical activity intervention in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Applied Health Sciences
Canfield, Ohio, 44406
About this study
The purpose of this placebo-controlled, double-blind study is to determine the effects of a commercially available (i.e. dietary supplement) Hemp Oil Extract product on various markers of physical and mental stress resilience, and perceived recovery from normal daily physical \& mental stress. Secondary purposes are to collect information on perceived appetite, mood, feelings of wellbeing, sleep quality, body composition and safety information via standard clinical chemistry panels of sera and plasma.
- Being tested
- Hemp arm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemp armDietary supplement
Hemp oil
| Study group | Role | What they receive |
|---|---|---|
| Hemp arm | Experimental | Randomly assignment to Hemp arm (60 mg/day of hemp oil extract x 6 weeks) Receives: Dietary Supplement: Hemp arm |
| Placebo arm | Placebo comparator | Randomly assigned to Placebo arm (60 mg/day of cellulose x 6 weeks) Receives: Dietary Supplement: Hemp arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Measured: baseline
Sleep quality
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Measured: week 3
Sleep quality
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Measured: week 6
Stress
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Measured: Baseline
Stress
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Measured: Week 3
Stress
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Measured: Week 6
Well-being
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Measured: Baseline
Well-being
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Measured: Week 3
Well-being
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Measured: Week 6
Readiness to perform exercise
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Measured: Baseline
Readiness to perform exercise
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Measured: Week 3
Readiness to perform exercise
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Measured: Week 6
Appetite
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Measured: Baseline
Appetite
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Measured: Week 3
Appetite
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Measured: Week 6
Body composition
DXA measurement
Measured: Baseline
Body composition
DXA measurement
Measured: Week 3
Body composition
DXA measurement
Measured: Week 6
Secondary outcomes (12)
Blood pressure
Measured in mm Hg
Measured: Baseline
Blood pressure
Measured in mm Hg
Measured: Week 3
Blood pressure
Measured in mm Hg
Measured: Week 6
Plasma liver enzyme
Alanine aminotransferase
Measured: Baseline
Plasma liver enzyme
Alanine aminotransferase
Measured: Week 3
Plasma liver enzyme
Alanine aminotransferase
Measured: Week 6
Plasma liver enzyme
Aspartate aminotransferase
Measured: Baseline
Plasma liver enzyme
Aspartate aminotransferase
Measured: Week 3
Plasma liver enzyme
Aspartate aminotransferase
Measured: Week 6
Plasma Lipid panel
Total cholesterol, LDL, HDL and triglycerides
Measured: Baseline
Plasma Lipid panel
Total cholesterol, LDL, HDL and triglycerides
Measured: Week 3
Plasma Lipid panel
Total cholesterol, LDL, HDL and triglycerides
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start27 Aug 2018
- Primary completion29 Aug 2019
- Study completion29 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Center for Applied Health Sciences, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294706
- Sponsor's protocol ID
- CVSI-001-2018
- Status last verified
- Mar 2020
- First submitted
- 2 Mar 2020
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lopez HL, Cesareo KR, Raub B, Kedia AW, Sandrock JE, Kerksick CM, Ziegenfuss TN. Effects of Hemp Extract on Markers of Wellness, Stress Resilience, Recovery and Clinical Biomarkers of Safety in Overweight, But Otherwise Healthy Subjects. J Diet Suppl. 2020;17(5):561-586. doi: 10.1080/19390211.2020.1765941. Epub 2020 May 27.
PubMed 32456572
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hemp Oil on Markers of Optimal Wellness, Stress Resilience and Recovery in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04294706
- Acronym / sponsor ID
- CVSI-001-2018
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- The Center for Applied Health Sciences, LLCIndustry (pharma, biotech, devices)
- Study start
- 27 Aug 2018 (actual)
- Primary completion
- 29 Aug 2019 (actual)
- Study completion
- 29 Aug 2019 (actual)
- First posted
- 4 Mar 2020 (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.
The purpose of this placebo-controlled, double-blind study is to determine the effects of a commercially available (i.e. dietary supplement) Hemp Oil Extract product on various markers of physical and mental stress resilience, and perceived recovery from normal daily physical \& mental stress. Secondary purposes are to collect information on perceived appetite, mood, feelings of wellbeing, sleep quality, body composition and safety information via standard clinical chemistry panels of sera and plasma.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemp arm | Experimental | Dietary Supplement: Hemp armRandomly assignment to Hemp arm (60 mg/day of hemp oil extract x 6 weeks) |
| Placebo arm | Placebo comparator | Dietary Supplement: Hemp armRandomly assigned to Placebo arm (60 mg/day of cellulose x 6 weeks) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subjects provide written and dated informed consent to participate in an IRB approved study.
- Subjects are in good health as determined by medical history and routine blood chemistries.
- Subjects are male or female between the ages of 18 and 55 (inclusive).
- Female subjects must agree to use barrier contraceptive methods during sexual intercourse for the duration of the study. All females will undergo pregnancy testing (urine HCG screen) before being screened and at each visit unless they present evidence of surgical sterilization by tubal ligation, bilateral oophorectomy or hysterectomy.
- Subjects have a Body Mass Index of 25-35.
Key exclusion criteria (23 listed)
- Subjects that currently exercise more than three times per week.
- Subject has used weight loss medications within the past three months of Screening visit.
- Subject is on thyroid medication at a dose that is not considered stable. Stable is defined as using the same dose consistently for at least 90 days.
- Subjects with any metabolic disorder including known electrolyte abnormalities, diabetes (or fasting glucose ≥126 mg/dL at the screening visit), unstable or unmanaged thyroid disease, or hypogonadism.
- Subjects with a history of hepato-renal, musculoskeletal, autoimmune, neurologic disease, or any other medical condition deemed exclusionary by the medical staff.
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 |
|---|---|---|
| Hemp armHemp oil | Dietary supplement | Hemp arm, Placebo arm |
Primary outcome
Sleep quality
Time frame: baseline
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Sleep quality
Time frame: week 3
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Sleep quality
Time frame: week 6
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Stress
Time frame: Baseline
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Stress
Time frame: Week 3
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Stress
Time frame: Week 6
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Well-being
Time frame: Baseline
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Well-being
Time frame: Week 3
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Well-being
Time frame: Week 6
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Readiness to perform exercise
Time frame: Baseline
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Readiness to perform exercise
Time frame: Week 3
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Readiness to perform exercise
Time frame: Week 6
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Appetite
Time frame: Baseline
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Appetite
Time frame: Week 3
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Appetite
Time frame: Week 6
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Body composition
Time frame: Baseline
DXA measurement
Body composition
Time frame: Week 3
DXA measurement
Body composition
Time frame: Week 6
DXA measurement
12 secondary outcomes
Blood pressure
Time frame: Baseline
Blood pressure
Time frame: Week 3
Blood pressure
Time frame: Week 6
Plasma liver enzyme
Time frame: Baseline
Plasma liver enzyme
Time frame: Week 3
Plasma liver enzyme
Time frame: Week 6
Plasma liver enzyme
Time frame: Baseline
Plasma liver enzyme
Time frame: Week 3
Plasma liver enzyme
Time frame: Week 6
Plasma Lipid panel
Time frame: Baseline
Plasma Lipid panel
Time frame: Week 3
Plasma Lipid panel
Time frame: Week 6
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 5 Mar 2020.
- Derived from this study: PubMed 32456572Lopez HL, Cesareo KR, Raub B, Kedia AW, Sandrock JE, Kerksick CM, Ziegenfuss TN. Effects of Hemp Extract on Markers of Wellness, Stress Resilience, Recovery and Clinical Biomarkers of Safety in Overweight, But Otherwise Healthy Subjects. J Diet Suppl. 2020;17(5):561-586. doi: 10.1080/19390211.2020.1765941. Epub 2020 May 27.
- Individual participant dataSharing planned: Undecided
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Healthy Adult Participants
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 Hemp arm in people with Sleep and Stress, run by The Center for Applied Health Sciences, LLC 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 8 inclusion and 23 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 5 Mar 2020. 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. Some participants in this study may receive a placebo. 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?
Sleep quality (time frame: baseline). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04294706, which also lists 1 linked publication.
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 5 Mar 2020.