Effects of Hemp Oil on Markers of Optimal Wellness, Stress Resilience and Recovery in Healthy Subjects

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 Overview

• Status: Completed
• Conditions: Stress; Sleep; Mood
• Intervention / Treatment: Dietary supplement: Hemp arm

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Canfield, Ohio, United States, 44406
      • The Center for Applied Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hemp arm; Randomly assignment to Hemp arm (60 mg/day of hemp oil extract x 6 weeks)	Dietary supplement: Hemp arm; Hemp oil
Placebo Comparator: Placebo arm; Randomly assigned to Placebo arm (60 mg/day of cellulose x 6 weeks)	Dietary supplement: Hemp arm; Hemp oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep quality	A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.	baseline
Sleep quality	A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.	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.	week 6
Stress	A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.	Baseline
Stress	A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.	Week 3
Stress	A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.	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.	Baseline
Well-being	A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.	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.	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.	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.	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.	Week 6
Appetite	A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.	Baseline
Appetite	A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.	Week 3
Appetite	A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.	Week 6
Body composition	DXA measurement	Baseline
Body composition	DXA measurement	Week 3
Body composition	DXA measurement	Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Measured in mm Hg	Baseline
Blood pressure	Measured in mm Hg	Week 3
Blood pressure	Measured in mm Hg	Week 6
Plasma liver enzyme	Alanine aminotransferase	Baseline
Plasma liver enzyme	Alanine aminotransferase	Week 3
Plasma liver enzyme	Alanine aminotransferase	Week 6
Plasma liver enzyme	Aspartate aminotransferase	Baseline
Plasma liver enzyme	Aspartate aminotransferase	Week 3
Plasma liver enzyme	Aspartate aminotransferase	Week 6
Plasma Lipid panel	Total cholesterol, LDL, HDL and triglycerides	Baseline
Plasma Lipid panel	Total cholesterol, LDL, HDL and triglycerides	Week 3
Plasma Lipid panel	Total cholesterol, LDL, HDL and triglycerides	Week 6

Collaborators and Investigators

• Sponsor: The Center for Applied Health Sciences, LLC

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2018
• Primary Completion (Actual): August 29, 2019
• Study Completion (Actual): August 29, 2019

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: March 2, 2020
• First Posted (Actual): March 4, 2020

Study Record Updates

• Last Update Posted (Actual): March 5, 2020
• Last Update Submitted That Met QC Criteria: March 3, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CVSI-001-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No