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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemp arm | Experimental | Randomly assignment to Hemp arm (60 mg/day of hemp oil extract x 6 weeks) |
|
| Placebo arm | Placebo Comparator | Randomly assigned to Placebo arm (60 mg/day of cellulose x 6 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemp arm | Dietary Supplement | Hemp oil |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Measured in mm Hg | Baseline |
| Blood pressure | Measured in mm Hg | Week 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Center for Applied Health Sciences | Canfield | Ohio | 44406 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32456572 | Derived | 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. |
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| 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 |
| 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 |