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

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04294706
• Other study ID #: CVSI-001-2018
• Status: Completed
• Phase: N/A
• Start date: August 27, 2018
• Est. completion date: August 29, 2019

Study information

• Verified date: March 2020
• Source: The Center for Applied Health Sciences, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: August 29, 2019
• Est. primary completion date: August 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mood
• Sleep
• Stress

Intervention

Dietary Supplement:
• Hemp arm
Hemp oil

Locations

Country	Name	City	State
United States	The Center for Applied Health Sciences	Canfield	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Center for Applied Health Sciences, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep quality	A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.	baseline
Primary	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
Primary	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
Primary	Stress	A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.	Baseline
Primary	Stress	A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.	Week 3
Primary	Stress	A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.	Week 6
Primary	Well-being	A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.	Baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Appetite	A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.	Baseline
Primary	Appetite	A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.	Week 3
Primary	Appetite	A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.	Week 6
Primary	Body composition	DXA measurement	Baseline
Primary	Body composition	DXA measurement	Week 3
Primary	Body composition	DXA measurement	Week 6
Secondary	Blood pressure	Measured in mm Hg	Baseline
Secondary	Blood pressure	Measured in mm Hg	Week 3
Secondary	Blood pressure	Measured in mm Hg	Week 6
Secondary	Plasma liver enzyme	Alanine aminotransferase	Baseline
Secondary	Plasma liver enzyme	Alanine aminotransferase	Week 3
Secondary	Plasma liver enzyme	Alanine aminotransferase	Week 6
Secondary	Plasma liver enzyme	Aspartate aminotransferase	Baseline
Secondary	Plasma liver enzyme	Aspartate aminotransferase	Week 3
Secondary	Plasma liver enzyme	Aspartate aminotransferase	Week 6
Secondary	Plasma Lipid panel	Total cholesterol, LDL, HDL and triglycerides	Baseline
Secondary	Plasma Lipid panel	Total cholesterol, LDL, HDL and triglycerides	Week 3
Secondary	Plasma Lipid panel	Total cholesterol, LDL, HDL and triglycerides	Week 6