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

NCT04294706 | Completed

• 1 other identifier: CVSI-001-2018
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Stress; Mood

Outcome Measures

Primary Outcomes (18)

• 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 Outcomes (12)

• Blood pressure

  Baseline

• Blood pressure

  Week 3

• Blood pressure

  Week 6

• Plasma liver enzyme

  Baseline

• Plasma liver enzyme

  Week 3

Study Arms (2)

Hemp arm

EXPERIMENTAL

Randomly assignment to Hemp arm (60 mg/day of hemp oil extract x 6 weeks)

Dietary Supplement: Hemp arm

Placebo arm

PLACEBO COMPARATOR

Randomly assigned to Placebo arm (60 mg/day of cellulose x 6 weeks)

Dietary Supplement: Hemp arm

Interventions

Hemp arm DIETARY_SUPPLEMENT

Hemp oil

Hemp arm; Placebo arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• The Center for Applied Health Sciences, LLC: lead

Study Sites (1)

The Center for Applied Health Sciences

Canfield, Ohio, 44406, United States

Location

Related Publications (1)

• 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.

  PMID: 32456572 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 4, 2020
• Study Start: August 27, 2018
• Primary Completion: August 29, 2019
• Study Completion: August 29, 2019
• Last Updated: March 5, 2020

Record last verified: 2020-03

Locations

US (1)