Clinical trial NCT04294706: Effects of Hemp Oil on Markers of Optimal Wellness, Stress Resilience and Recovery in Healthy Subjects
Official title: Effects of Hemp Oil on Markers of Optimal Wellness, Stress Resilience and Recovery in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Stress
Mood
Lead sponsor: The Center for Applied Health Sciences, LLC
Sponsor class: INDUSTRY
First posted: 2020-03-04
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Sleep quality
timeFrame: baseline
measure: Sleep quality
timeFrame: week 3
measure: Sleep quality
timeFrame: week 6
measure: Stress
timeFrame: Baseline
measure: Stress
timeFrame: Week 3
measure: Stress
timeFrame: Week 6
measure: Well-being
timeFrame: Baseline
measure: Well-being
timeFrame: Week 3
measure: Well-being
timeFrame: Week 6
measure: Readiness to perform exercise
timeFrame: Baseline
measure: Readiness to perform exercise
timeFrame: Week 3
measure: Readiness to perform exercise
timeFrame: Week 6
measure: Appetite
timeFrame: Baseline
measure: Appetite
timeFrame: Week 3
measure: Appetite
timeFrame: Week 6
measure: Body composition
timeFrame: Baseline
measure: Body composition
timeFrame: Week 3
measure: Body composition
timeFrame: Week 6
Secondary outcomes:
measure: Blood pressure
timeFrame: Baseline
measure: Blood pressure
timeFrame: Week 3
measure: Blood pressure
timeFrame: Week 6
measure: Plasma liver enzyme
timeFrame: Baseline
measure: Plasma liver enzyme
timeFrame: Week 3
measure: Plasma liver enzyme
timeFrame: Week 6
measure: Plasma liver enzyme
timeFrame: Baseline
measure: Plasma liver enzyme
timeFrame: Week 3
measure: Plasma liver enzyme
timeFrame: Week 6
measure: Plasma Lipid panel
timeFrame: Baseline
measure: Plasma Lipid panel
timeFrame: Week 3
measure: Plasma Lipid panel
timeFrame: Week 6
Other outcomes:
Locations:
city: Canfield
country: United States
facility: The Center for Applied Health Sciences
state: Ohio
Study officials:
References:
citation: 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.