- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03065166
Dried Cabernet Grapes and Cardiovascular Risk Markers (RZN)
Effects of CabernayZyns (Dried Cabernet Grapes) Intake on Vascular Function and Platelet Reactivity in Postmenopausal Women
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The initiation and progression of atherosclerotic cardiovascular disease (CVD) is multifactorial in nature, and is currently thought of as a chronic inflammatory condition. To reduce the risk of CVD and its associated health care costs in California and elsewhere, nutrition and health recommendations strongly advocate the consumption of a diet rich in fruits and vegetables. Such recommendations are based largely on epidemiological data; the mechanisms underlying the putative positive effects of plant food-rich diets are poorly defined and an area of active debate.
In addition to essential vitamins and minerals, fruits and vegetables contain a number of bioactive compounds that may be involved in vascular function. In this regard, epidemiological studies have noted a significant inverse relationship between the intake of plant foods rich in polyphenols and the risk of both all-cause mortality and CVD. For example, the "French paradox" refers to diet patterns that, despite being high in saturated fat, are associated with a relatively low cardiovascular risk, which may be due, in part, to a robust intake of polyphenols found in red wine, grapes, and other plant foods. Red wine contains an array of phytochemicals that have been proposed to improve cardiovascular health, with a great focus on polyphenols. However, grape products such as dried cabernet grapes also contain substantial amounts of polyphenols that may be vasculoprotective.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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California
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Davis, California, Stati Uniti, 95616
- Ragle Human Nutrition Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Postmenopausal female: 50-70 years
- Women: lack of menses for at least one year and FSH 23-116.3 mlU/mL
- Subject is willing and able to comply with the study protocols.
- Subject is willing to participate in all study procedures
- BMI 25.0 - 40 kg/m2
- Weight ≥ 110 pounds
Exclusion Criteria:
- BMI ≥ 40 kg/m2
- Dislike or allergy for grape products and raisins
- Self-reported use of daily anticoagulation agents including aspirin, NSAIDs
- Vegan, Vegetarians, food faddists or those consuming a non-traditional diet
- Alcohol consumption > 3 drinks/week (i.e. 1 bottle of beer, 1 glass of wine, and 1 shot of hard liquor)
- Fruit consumption ≥ 2 cups/day
- Vegetable consumption ≥ 3 cups/day for females
- Fatty Fish ≥ 3 times/week
- Coffee/tea ≥ 3 cups/day
- Dark chocolate ≥ 3 oz/day
- Self-reported restriction of physical activity due to a chronic health condition
- Self-reported chronic/routine high intensity exercise
- Self-reported diabetes
- Blood pressure ≥ 140/90 mm Hg
- Self-reported renal or liver disease
- Self-reported heart disease, which includes cardiovascular events and stroke
- Inability to properly place or wear the PAT probes or abnormal measurements on pre-screening PAT
- Abnormal Liver, CBC or Chemistry panels (laboratory values outside the reference range) if determined to be clinically significant by the study physician.
- Self-reported cancer within past 5 years
- Self-reported malabsorption
- Currently taking prescription drugs or supplements.
- Use of multi-vitamin and mineral other than a general formula of vitamins and minerals that meet the RDA
- Not willing to stop any supplement use, including herbal, plant or botanical, fish oil, oil supplements a month prior to study enrollment.
- Indications of substance or alcohol abuse within the last 3 years
- Screening LDL ≥ 190 mg/dl for those who have 0-1 major risk factors apart from LDL cholesterol (i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL].
- Screening LDL ≥ 160 mg/dl for those who have 2 major risk factors apart from LDL cholesterol [i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL].
(using NCEP calculator http://cvdrisk.nhlbi.nih.gov/calculator.asp);
- Screening LDL ≥ 130 mg/dl for those who have 2 major risk factors apart from LDL cholesterol [i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL], and a Framingham 10-year Risk Score 10-20% (using NCEP calculator http://cvdrisk.nhlbi.nih.gov/calculator.asp).
- Current enrollee in a clinical research study.
The following special populations will be excluded:
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Raisin Treatment
3.2 ounces of dried Cabernet wine grapes.
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Subjects will consume 3.2oz of dried Cabernet grapes during a single intervention time point.
Subjects will consume 95g of whole wheat bagel during a single intervention time point.
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Altro: Bagel Control
One 95g whole wheat bagel.
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Subjects will consume 3.2oz of dried Cabernet grapes during a single intervention time point.
Subjects will consume 95g of whole wheat bagel during a single intervention time point.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Postprandial Micro-vascular Function
Lasso di tempo: Baseline and 2-hour measures on day 0 and day 7.
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To determine whether an acute intake of dried Cabernet grapes will improve vascular function, as measured using peripheral artery tonometry (PAT).
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Baseline and 2-hour measures on day 0 and day 7.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Platelet Aggregation
Lasso di tempo: Baseline and 2-hour measures on day 0 and day 7.
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To determine whether an acute intake of dried Cabernet grapes will alter platelet reactivity, as measured by Chrono-log platelet aggregometer device.
|
Baseline and 2-hour measures on day 0 and day 7.
|
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Nitrate/Nitrite
Lasso di tempo: Baseline and 2-hour measures on day 0 and day 7.
|
Blood analysis to determine whether an acute intake of dried Cabernet grapes will affect plasma circulating nitrate and nitrite levels.
|
Baseline and 2-hour measures on day 0 and day 7.
|
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Baseline Complete Metabolic Panel
Lasso di tempo: Baseline measures on day 0 and day 7.
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Blood analyses will include measurements of complete blood cell count, comprehensive metabolic panel, and lipid profile.
|
Baseline measures on day 0 and day 7.
|
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Postprandial Complete Metabolic Panel
Lasso di tempo: 2-hour measures on day 0 and day 7.
|
Blood analyses will include measurements of complete blood cell count, comprehensive metabolic panel, and lipid profile.
|
2-hour measures on day 0 and day 7.
|
|
Body Weight
Lasso di tempo: Baseline measure on day 0 and day 7.
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Body weight will be recorded at baseline on initial visit as well as visit one week after.
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Baseline measure on day 0 and day 7.
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Blood Pressure
Lasso di tempo: Baseline measure on day 0 and day 7.
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The office blood pressure measurement will be obtained (3 measurements 5 minutes apart after a 15 minute rest).
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Baseline measure on day 0 and day 7.
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Collaboratori e investigatori
Sponsor
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 (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 944091
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
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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