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Dried Cabernet Grapes and Cardiovascular Risk Markers (RZN)

3. oktober 2017 opdateret af: University of California, Davis

Effects of CabernayZyns (Dried Cabernet Grapes) Intake on Vascular Function and Platelet Reactivity in Postmenopausal Women

This study assesses the acute effects of dried Cabernet grape intake on vascular function and platelet reactivity in postmenopausal women. Previous studies from this lab and others have demonstrated acute effects on vascular function and platelet reactivity from phenolic-rich food sources. Postmenopausal women are suggested as the study group, as they are likely to have compromised vascular function due to the loss of protective estrogen, and have been the study group for past and present research projects in this lab.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • California
      • Davis, California, Forenede Stater, 95616
        • Ragle Human Nutrition Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Raisin Treatment
3.2 ounces of dried Cabernet wine grapes.
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.
Andet: Bagel Control
One 95g whole wheat bagel.
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Postprandial Micro-vascular Function
Tidsramme: Baseline and 2-hour measures on day 0 and day 7.
To determine whether an acute intake of dried Cabernet grapes will improve vascular function, as measured using peripheral artery tonometry (PAT).
Baseline and 2-hour measures on day 0 and day 7.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Platelet Aggregation
Tidsramme: Baseline and 2-hour measures on day 0 and day 7.
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.
Nitrate/Nitrite
Tidsramme: 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.
Baseline Complete Metabolic Panel
Tidsramme: Baseline measures on day 0 and day 7.
Blood analyses will include measurements of complete blood cell count, comprehensive metabolic panel, and lipid profile.
Baseline measures on day 0 and day 7.
Postprandial Complete Metabolic Panel
Tidsramme: 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
Tidsramme: Baseline measure on day 0 and day 7.
Body weight will be recorded at baseline on initial visit as well as visit one week after.
Baseline measure on day 0 and day 7.
Blood Pressure
Tidsramme: Baseline measure on day 0 and day 7.
The office blood pressure measurement will be obtained (3 measurements 5 minutes apart after a 15 minute rest).
Baseline measure on day 0 and day 7.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2016

Primær færdiggørelse (Faktiske)

1. april 2017

Studieafslutning (Faktiske)

1. juli 2017

Datoer for studieregistrering

Først indsendt

14. februar 2017

Først indsendt, der opfyldte QC-kriterier

21. februar 2017

Først opslået (Faktiske)

27. februar 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. oktober 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. oktober 2017

Sidst verificeret

1. oktober 2017

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 944091

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Kliniske forsøg med Sunde, postmenopausale kvinder

Kliniske forsøg med Raisin Treatment

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