- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04294706
Effects of Hemp Oil on Markers of Optimal Wellness, Stress Resilience and Recovery in Healthy Subjects
3 marzo 2020 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
65
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Ohio
-
Canfield, Ohio, Stati Uniti, 44406
- The Center for Applied Health Sciences
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 55 anni (Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Hemp arm
Randomly assignment to Hemp arm (60 mg/day of hemp oil extract x 6 weeks)
|
Hemp oil
|
Comparatore placebo: Placebo arm
Randomly assigned to Placebo arm (60 mg/day of cellulose x 6 weeks)
|
Hemp oil
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Sleep quality
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline
|
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
|
Baseline
|
Stress
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline
|
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
|
Baseline
|
Appetite
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline
|
DXA measurement
|
Baseline
|
Body composition
Lasso di tempo: Week 3
|
DXA measurement
|
Week 3
|
Body composition
Lasso di tempo: Week 6
|
DXA measurement
|
Week 6
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Blood pressure
Lasso di tempo: Baseline
|
Measured in mm Hg
|
Baseline
|
Blood pressure
Lasso di tempo: Week 3
|
Measured in mm Hg
|
Week 3
|
Blood pressure
Lasso di tempo: Week 6
|
Measured in mm Hg
|
Week 6
|
Plasma liver enzyme
Lasso di tempo: Baseline
|
Alanine aminotransferase
|
Baseline
|
Plasma liver enzyme
Lasso di tempo: Week 3
|
Alanine aminotransferase
|
Week 3
|
Plasma liver enzyme
Lasso di tempo: Week 6
|
Alanine aminotransferase
|
Week 6
|
Plasma liver enzyme
Lasso di tempo: Baseline
|
Aspartate aminotransferase
|
Baseline
|
Plasma liver enzyme
Lasso di tempo: Week 3
|
Aspartate aminotransferase
|
Week 3
|
Plasma liver enzyme
Lasso di tempo: Week 6
|
Aspartate aminotransferase
|
Week 6
|
Plasma Lipid panel
Lasso di tempo: Baseline
|
Total cholesterol, LDL, HDL and triglycerides
|
Baseline
|
Plasma Lipid panel
Lasso di tempo: Week 3
|
Total cholesterol, LDL, HDL and triglycerides
|
Week 3
|
Plasma Lipid panel
Lasso di tempo: Week 6
|
Total cholesterol, LDL, HDL and triglycerides
|
Week 6
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
27 agosto 2018
Completamento primario (Effettivo)
29 agosto 2019
Completamento dello studio (Effettivo)
29 agosto 2019
Date di iscrizione allo studio
Primo inviato
2 marzo 2020
Primo inviato che soddisfa i criteri di controllo qualità
2 marzo 2020
Primo Inserito (Effettivo)
4 marzo 2020
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
5 marzo 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
3 marzo 2020
Ultimo verificato
1 marzo 2020
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- CVSI-001-2018
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Indeciso
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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