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

3 maart 2020 bijgewerkt door: The Center for Applied Health Sciences, LLC
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.

Studie Overzicht

Toestand

Voltooid

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

65

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Ohio
      • Canfield, Ohio, Verenigde Staten, 44406
        • The Center for Applied Health Sciences

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 55 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Hemp arm
Randomly assignment to Hemp arm (60 mg/day of hemp oil extract x 6 weeks)
Hemp oil
Placebo-vergelijker: Placebo arm
Randomly assigned to Placebo arm (60 mg/day of cellulose x 6 weeks)
Hemp oil

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Sleep quality
Tijdsspanne: baseline
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
baseline
Sleep quality
Tijdsspanne: week 3
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
Tijdsspanne: week 6
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
week 6
Stress
Tijdsspanne: Baseline
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Baseline
Stress
Tijdsspanne: Week 3
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Week 3
Stress
Tijdsspanne: Week 6
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
Tijdsspanne: Baseline
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Baseline
Well-being
Tijdsspanne: Week 3
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
Tijdsspanne: Week 6
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
Tijdsspanne: Baseline
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
Tijdsspanne: Week 3
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
Tijdsspanne: Week 6
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Week 6
Appetite
Tijdsspanne: Baseline
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Baseline
Appetite
Tijdsspanne: Week 3
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Week 3
Appetite
Tijdsspanne: Week 6
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
Tijdsspanne: Baseline
DXA measurement
Baseline
Body composition
Tijdsspanne: Week 3
DXA measurement
Week 3
Body composition
Tijdsspanne: Week 6
DXA measurement
Week 6

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Blood pressure
Tijdsspanne: Baseline
Measured in mm Hg
Baseline
Blood pressure
Tijdsspanne: Week 3
Measured in mm Hg
Week 3
Blood pressure
Tijdsspanne: Week 6
Measured in mm Hg
Week 6
Plasma liver enzyme
Tijdsspanne: Baseline
Alanine aminotransferase
Baseline
Plasma liver enzyme
Tijdsspanne: Week 3
Alanine aminotransferase
Week 3
Plasma liver enzyme
Tijdsspanne: Week 6
Alanine aminotransferase
Week 6
Plasma liver enzyme
Tijdsspanne: Baseline
Aspartate aminotransferase
Baseline
Plasma liver enzyme
Tijdsspanne: Week 3
Aspartate aminotransferase
Week 3
Plasma liver enzyme
Tijdsspanne: Week 6
Aspartate aminotransferase
Week 6
Plasma Lipid panel
Tijdsspanne: Baseline
Total cholesterol, LDL, HDL and triglycerides
Baseline
Plasma Lipid panel
Tijdsspanne: Week 3
Total cholesterol, LDL, HDL and triglycerides
Week 3
Plasma Lipid panel
Tijdsspanne: Week 6
Total cholesterol, LDL, HDL and triglycerides
Week 6

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

27 augustus 2018

Primaire voltooiing (Werkelijk)

29 augustus 2019

Studie voltooiing (Werkelijk)

29 augustus 2019

Studieregistratiedata

Eerst ingediend

2 maart 2020

Eerst ingediend dat voldeed aan de QC-criteria

2 maart 2020

Eerst geplaatst (Werkelijk)

4 maart 2020

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 maart 2020

Laatste update ingediend die voldeed aan QC-criteria

3 maart 2020

Laatst geverifieerd

1 maart 2020

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • CVSI-001-2018

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Onbeslist

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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