- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01551706
Pilot Study to Evaluate the Effect of ENI Patented Whole Grape Extract on Antioxidant Status
A Randomized, Double-blind, Placebo-controlled, Pilot Study to Evaluate the Effect of ENI Patented Whole Grape Extract on Antioxidant Status
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This study will investigate the effect of ENI Patented Whole Grape Extract versus placebo on antioxidant status. The primary objective is to determine antioxidant status by measuring total antioxidant capacity and superoxide dismutase (SOD) in blood and 8-OHdG and 8-isoprostane in first morning void urine samples prior to and after six weeks of supplementation with ENI Patented Whole Grape Extract.
Secondary objectives will include the assessment of oxidized LDL (oxLDL) and safety evaluations:
- oxLDL
- Safety laboratory tests: CBC, electrolytes, glucose, creatinine, eGFR, AST, ALT, GGT,bilirubin
- Vital signs: heart rate and blood pressure
- Adverse events
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
-
-
Ontario
-
London, Ontario, Canada, N6A 5R8
- KGK Synergize Inc.
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Male or female 18 - 65 years of age
If female, subject is not of child bearing potential. Defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation).
OR Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:
- Double-barrier method (condoms with spermicide or diaphragm with spermicide)
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- Intrauterine devices
- Vasectomy of partner (shown successful as per appropriate follow-up)
- Abstinence
One or more of the following conditions:
- Pre-hypertension defined as diastolic blood pressure of 80-89 mmHg and systolic blood pressure of 139 or lower at screening
- BMI from 25.0 to 34.9 kg/m2
- Pre-diabetes defined as a fasting plasma glucose from 5.2 to 6.9 mmol/L
- Subjects who are smokers agree to report smoking habits at each visit and do not plan on changing their smoking habits during the study.
- Has given voluntary, written, informed consent to participate in the study
Exclusion Criteria:
- Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- Subject has any clinically significant medical conditions including cardiovascular disease,hypertension (systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90mmHg), diabetes, liver or kidney disease
- Use of medication for the treatment of hypertension
- Use of medication for vasodilation, including nitric oxide releasing patches
- Use of medication for erectile dysfunction
- Use of medication (prescribed or over the counter) for weight loss
- Use of statins, fibrates, niacin, or any other medication for the treatment of hypercholesterolemia
- Use of anticoagulants
- Use of illicit drugs or history of drug or alcohol abuse with the past 5 years (currently having more than 2 standard alcoholic drinks per day)
- Use of natural health products (NHPs)/dietary supplements that are known to have significant antioxidant activity within 2 weeks prior to baseline and during the course of the study including but not limited to vitamins A, C, and E, selenium and zinc.
- Participation in a clinical research trial within 30 days prior to baseline
Clinically significant abnormal laboratory results at screening including
- AST, ALT and/or bilirubin > 2 x the ULN
- Serum creatinine >1.5 x the ULN or eGFR < 60
- hemoglobin < 140 g/L for males and < 123 g/L for females
- Allergy or sensitivity to test product ingredients
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore attivo: ENI Patented Whole Grape Extract
ENI Patented Whole Grape Extract (350 mg) per day
|
ENI Patented Whole Grape Extract
Altri nomi:
|
Comparatore placebo: Exicipient pill
|
Placebo
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change from baseline on oxidation stress biomarkers including total antioxidant capacity, superoxide dismutase (SOD), 8-OHdG and 8-isoprostane
Lasso di tempo: 6 weeks
|
This study will investigate the effect of ENI Patented Whole Grape Extract versus placebo on antioxidant status.
The primary objective is to determine antioxidant status by measuring total antioxidant capacity and superoxide dismutase (SOD) in blood and 8-OHdG and 8-isoprostane in first morning void urine samples prior to and after six weeks of supplementation with ENI Patented Whole Grape Extract.
|
6 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change from baseline in oxidized LDL (oxLDL).
Lasso di tempo: 6 weeks
|
Secondary objectives will include the assessment of oxidized LDL (oxLDL)
|
6 weeks
|
Change from baseline in safety lab test biomarkers including CBC, electrolytes, glucose, creatinine, eGFR, AST, ALT, GGT, and bilirubin
Lasso di tempo: 6 weeks
|
This study will include the safety evaluations and measure if there are any abnormal levels of CBC, electrolytes, glucose, creatinine, eGFR, AST, ALT, GGT,and bilirubin.
|
6 weeks
|
Change from baseline in vital signs: heart rate and blood pressure
Lasso di tempo: 6 weeks
|
This study will include measurement on change from baseline in vital signs: heart rate and blood pressure
|
6 weeks
|
Number of participants with adverse events
Lasso di tempo: 6 weeks
|
This study will also assess number of participants with adverse events during the entire intervention period.
|
6 weeks
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Dale Wilson, KGK Science Inc.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 11OAHE
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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