- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
-
-
Ontario
-
London, Ontario, Kanada, N6A 5R8
- KGK Synergize Inc.
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Aktiver Komparator: ENI Patented Whole Grape Extract
ENI Patented Whole Grape Extract (350 mg) per day
|
ENI Patented Whole Grape Extract
Andere Namen:
|
Placebo-Komparator: Exicipient pill
|
Placebo
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change from baseline on oxidation stress biomarkers including total antioxidant capacity, superoxide dismutase (SOD), 8-OHdG and 8-isoprostane
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change from baseline in oxidized LDL (oxLDL).
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 6 weeks
|
This study will also assess number of participants with adverse events during the entire intervention period.
|
6 weeks
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Dale Wilson, KGK Science Inc.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 11OAHE
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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