- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01748617
The Potential for Pomegranate Juice to Ameliorate Endothelial Dysfunction
27. august 2013 opdateret af: Janet Novotny
This study will be a randomized, double-blind, crossover intervention to investigate the health effects of acute ingestion of pomegranate juice when consumed with a high fat meal.
After one week of controlled dietary intervention, subjects will consume a high fat morning meal supplemented with either pomegranate juice or a juice-free sweetened beverage.
After consumption of the breakfast meal, subjects will be assessed for endothelial function and postprandial meal response.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
12
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Maryland
-
Beltsville, Maryland, Forenede Stater, 20705
- USDA Beltsville Human Nutrition Research 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
25 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Men and women between the ages of 25-70 years
- Body mass index (BMI) ≥ 19 and ≤ 38
- Willingness and ability to make scheduled appointments at clinical site as required by study protocol
Exclusion Criteria:
- Known (self-reported) allergy or adverse reaction to study foods
- Presence of kidney disease, liver disease, gout, untreated or unstable hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
- Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
- Fasting triglycerides > 300 mg/dL
- Fasting glucose > 126 mg/dL
- Use of cholesterol lowering medication
- Blood pressure > 180/100 or hypertension treated with calcium channel blockers, direct acting vasodilators, or beta blockers
- Fingernails longer than 0.25 inch beyond the finger tip, or unwillingness to cut fingernails to this length during endothelial function testing
- History of bariatric or certain other surgeries related to weight control
- History of major surgery within 3 months of enrollment
- Smokers or other tobacco users (during 6 months prior to the start of the study)
- Antibiotic use during the intervention or for 3 months prior to the intervention period
- History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
- Volunteers who have lost 10% of body weight within the last 6 months
- Unable or unwilling to give informed consent or communicate with study staff
- Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
- Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
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: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Pomegranate Juice
Acute ingestion of pomegranate juice with high fat meal.
|
1 week of controlled diet
|
Placebo komparator: Control
Acute ingestion of juice-free sweetened beverage with high fat meal.
|
1 week of controlled diet
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in endothelial function
Tidsramme: 0 hour and 3 hour
|
After a consuming controlled diet for 1 week, subjects will report in the morning after a 12 hour fast.
Upon arrival , subjects' endothelial function will be assessed by measuring endothelium-dependent flow mediated dilation of the peripheral bed (EndoPAT, Itamar Medical, Israel).
For this test, subjects will rest in the supine position with a brachial blood pressure cuff on one arm and a finger tip probe on each of two fingers (one on the left hand, one on the right hand).
After 5 minutes of rest, the blood pressure cuff will be inflated and remain inflated for 5 minutes.
Then the cuff pressure will be released and the subject will remain resting for 5 additional minutes.
This test will be repeated 3 hours after the test meal.
|
0 hour and 3 hour
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Janet Novotny, Ph.D., USDA Beltsville Human Nutrition Research Center
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. december 2012
Primær færdiggørelse (Faktiske)
1. januar 2013
Studieafslutning (Faktiske)
1. januar 2013
Datoer for studieregistrering
Først indsendt
10. december 2012
Først indsendt, der opfyldte QC-kriterier
10. december 2012
Først opslået (Skøn)
12. december 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
28. august 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. august 2013
Sidst verificeret
1. august 2013
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- HS41
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Controlled diet
-
Mondelēz International, Inc.KGK Science Inc.Afsluttet
-
Mondelēz International, Inc.KGK Science Inc.Afsluttet
-
University of FloridaPerformance HealthTrukket tilbage
-
University of Alabama at BirminghamNational Multiple Sclerosis SocietyAfsluttetMultipel scleroseForenede Stater
-
University Hospital of North NorwayUniversity of Tromso; University of Manchester; Helse NordAfsluttet
-
Salus UniversityUkendtIntermitterende eksotropiForenede Stater
-
First Hospital of China Medical UniversityLaval UniversityUkendtFjernstyret Mandibular PositionerCanada, Kina
-
Università degli Studi di BresciaAfsluttet
-
Loma Linda UniversityÖssur EhfRekrutteringTransfemoral amputationForenede Stater
-
Rothman Institute OrthopaedicsTilmelding efter invitation