Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

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

3 de março de 2020 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

65

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Ohio
      • Canfield, Ohio, Estados Unidos, 44406
        • The Center for Applied Health Sciences

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 55 anos (Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Hemp arm
Randomly assignment to Hemp arm (60 mg/day of hemp oil extract x 6 weeks)
Hemp oil
Comparador de Placebo: Placebo arm
Randomly assigned to Placebo arm (60 mg/day of cellulose x 6 weeks)
Hemp oil

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Sleep quality
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Baseline
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Baseline
Stress
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Baseline
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Baseline
Appetite
Prazo: 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
Prazo: 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
Prazo: Baseline
DXA measurement
Baseline
Body composition
Prazo: Week 3
DXA measurement
Week 3
Body composition
Prazo: Week 6
DXA measurement
Week 6

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Blood pressure
Prazo: Baseline
Measured in mm Hg
Baseline
Blood pressure
Prazo: Week 3
Measured in mm Hg
Week 3
Blood pressure
Prazo: Week 6
Measured in mm Hg
Week 6
Plasma liver enzyme
Prazo: Baseline
Alanine aminotransferase
Baseline
Plasma liver enzyme
Prazo: Week 3
Alanine aminotransferase
Week 3
Plasma liver enzyme
Prazo: Week 6
Alanine aminotransferase
Week 6
Plasma liver enzyme
Prazo: Baseline
Aspartate aminotransferase
Baseline
Plasma liver enzyme
Prazo: Week 3
Aspartate aminotransferase
Week 3
Plasma liver enzyme
Prazo: Week 6
Aspartate aminotransferase
Week 6
Plasma Lipid panel
Prazo: Baseline
Total cholesterol, LDL, HDL and triglycerides
Baseline
Plasma Lipid panel
Prazo: Week 3
Total cholesterol, LDL, HDL and triglycerides
Week 3
Plasma Lipid panel
Prazo: Week 6
Total cholesterol, LDL, HDL and triglycerides
Week 6

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

27 de agosto de 2018

Conclusão Primária (Real)

29 de agosto de 2019

Conclusão do estudo (Real)

29 de agosto de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

2 de março de 2020

Enviado pela primeira vez que atendeu aos critérios de CQ

2 de março de 2020

Primeira postagem (Real)

4 de março de 2020

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de março de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de março de 2020

Última verificação

1 de março de 2020

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • CVSI-001-2018

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Indeciso

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever