Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

65

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Ohio
      • Canfield, Ohio, Forenede Stater, 44406
        • The Center for Applied Health Sciences

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 55 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Hemp arm
Randomly assignment to Hemp arm (60 mg/day of hemp oil extract x 6 weeks)
Hemp oil
Placebo komparator: Placebo arm
Randomly assigned to Placebo arm (60 mg/day of cellulose x 6 weeks)
Hemp oil

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sleep quality
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Baseline
Stress
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Baseline
Appetite
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline
DXA measurement
Baseline
Body composition
Tidsramme: Week 3
DXA measurement
Week 3
Body composition
Tidsramme: Week 6
DXA measurement
Week 6

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Blood pressure
Tidsramme: Baseline
Measured in mm Hg
Baseline
Blood pressure
Tidsramme: Week 3
Measured in mm Hg
Week 3
Blood pressure
Tidsramme: Week 6
Measured in mm Hg
Week 6
Plasma liver enzyme
Tidsramme: Baseline
Alanine aminotransferase
Baseline
Plasma liver enzyme
Tidsramme: Week 3
Alanine aminotransferase
Week 3
Plasma liver enzyme
Tidsramme: Week 6
Alanine aminotransferase
Week 6
Plasma liver enzyme
Tidsramme: Baseline
Aspartate aminotransferase
Baseline
Plasma liver enzyme
Tidsramme: Week 3
Aspartate aminotransferase
Week 3
Plasma liver enzyme
Tidsramme: Week 6
Aspartate aminotransferase
Week 6
Plasma Lipid panel
Tidsramme: Baseline
Total cholesterol, LDL, HDL and triglycerides
Baseline
Plasma Lipid panel
Tidsramme: Week 3
Total cholesterol, LDL, HDL and triglycerides
Week 3
Plasma Lipid panel
Tidsramme: Week 6
Total cholesterol, LDL, HDL and triglycerides
Week 6

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

27. august 2018

Primær færdiggørelse (Faktiske)

29. august 2019

Studieafslutning (Faktiske)

29. august 2019

Datoer for studieregistrering

Først indsendt

2. marts 2020

Først indsendt, der opfyldte QC-kriterier

2. marts 2020

Først opslået (Faktiske)

4. marts 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. marts 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. marts 2020

Sidst verificeret

1. marts 2020

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • CVSI-001-2018

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Uafklaret

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Hemp arm

3
Abonner