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

3 mars 2020 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

65

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Ohio
      • Canfield, Ohio, États-Unis, 44406
        • The Center for Applied Health Sciences

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 55 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Hemp arm
Randomly assignment to Hemp arm (60 mg/day of hemp oil extract x 6 weeks)
Hemp oil
Comparateur placebo: Placebo arm
Randomly assigned to Placebo arm (60 mg/day of cellulose x 6 weeks)
Hemp oil

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Sleep quality
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Baseline
Stress
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Baseline
Appetite
Délai: 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
Délai: 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
Délai: Baseline
DXA measurement
Baseline
Body composition
Délai: Week 3
DXA measurement
Week 3
Body composition
Délai: Week 6
DXA measurement
Week 6

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Blood pressure
Délai: Baseline
Measured in mm Hg
Baseline
Blood pressure
Délai: Week 3
Measured in mm Hg
Week 3
Blood pressure
Délai: Week 6
Measured in mm Hg
Week 6
Plasma liver enzyme
Délai: Baseline
Alanine aminotransferase
Baseline
Plasma liver enzyme
Délai: Week 3
Alanine aminotransferase
Week 3
Plasma liver enzyme
Délai: Week 6
Alanine aminotransferase
Week 6
Plasma liver enzyme
Délai: Baseline
Aspartate aminotransferase
Baseline
Plasma liver enzyme
Délai: Week 3
Aspartate aminotransferase
Week 3
Plasma liver enzyme
Délai: Week 6
Aspartate aminotransferase
Week 6
Plasma Lipid panel
Délai: Baseline
Total cholesterol, LDL, HDL and triglycerides
Baseline
Plasma Lipid panel
Délai: Week 3
Total cholesterol, LDL, HDL and triglycerides
Week 3
Plasma Lipid panel
Délai: Week 6
Total cholesterol, LDL, HDL and triglycerides
Week 6

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

27 août 2018

Achèvement primaire (Réel)

29 août 2019

Achèvement de l'étude (Réel)

29 août 2019

Dates d'inscription aux études

Première soumission

2 mars 2020

Première soumission répondant aux critères de contrôle qualité

2 mars 2020

Première publication (Réel)

4 mars 2020

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 mars 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 mars 2020

Dernière vérification

1 mars 2020

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • CVSI-001-2018

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Indécis

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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