Prostate Biomarkers in Men Consuming Tomato Products
12. november 2014 opdateret af: Steven Clinton, Ohio State University Comprehensive Cancer Center
Prostate Biomarkers in Men Consuming Tomato Products
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Participants completed a minimum week-long washout period without consumption of tomato products prior to randomization to one of four dietary interventions.
Men were randomized to one of the following dietary interventions: a controlled low lycopene diet (≤ 5 mg/d from foods), daily Prego® spaghetti sauce, daily V8® vegetable juice, or daily Campbell's® Tomato Soup.
Each of the tomato products provided between 25 and 35 mg lycopene per day.
In order to provide this dietary intervention in typical serving sizes in the context of a usual diet but devoid of other tomato sources, participants kept daily logs documenting compliance with the intervention product and a tomato-restricted diet from enrollment to the day of surgery (~3 weeks).
Study participants were asked to complete an abbreviated dietary history questionnaire (to establish typical consumption patterns of various tomato products) and two separate 3-day diet food records, once during the washout and once during the intervention period.
Blood and 24-hour urine samples were obtained at two time points, after the one-week washout phase and at the end of the dietary intervention period.
Fresh prostate samples were obtained at time of surgery.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
33
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Ohio
-
Columbus, Ohio, Forenede Stater, 43210
- The Ohio State University Comprehensive Cancer Center/ We
-
-
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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria: To be included in this study, men must:
- Have biopsy-proven, clinically localized adenocarcinoma of the prostate based on standard presurgical staging studies
- Have chosen to undergo a radical prostatectomy for treatment of their disease after the medical team has presented all possible treatment options
- Have kidney and liver enzymes, CBC, and PT/PTT/INR within normal limits
- Agree to sign consent form prior to enrollment in the study
Exclusion Criteria: Men may not participate in this if they:
- Are currently taking lycopene or "alternative" dietary supplements
- Have a history of digestive or malabsorptive disorders, metabolic enzyme deficiencies, or other disorders requiring special dietary modifications (controlled type II diabetes mellitus was allowed)
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: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Arm I: Control
Men in this group consumed a tomato free diet for the duration of the study (less than or equal to 5 mg lycopene/day) and, thus, did not consume a tomato intervention product.
|
|
|
Eksperimentel: Arm II: Juice
Commercially-available tomato food product: men in this group consumed V8® juice (11-16.5 fl.
oz./day).
|
Each of the three tomato food products (juice, soup, sauce) provided 25-35 mg lycopene/day.
|
|
Eksperimentel: Arm III: Soup
Commercially-available tomato food product: men in this group consumed Campbell's® Tomato Soup (2-2 ¾ cups/day).
|
Each of the three tomato food products (juice, soup, sauce) provided 25-35 mg lycopene/day.
|
|
Eksperimentel: Arm IV: Sauce
Commercially-available tomato food product: men in this group consumed Prego® spaghetti sauce (5-7 oz./day).
|
Each of the three tomato food products (juice, soup, sauce) provided 25-35 mg lycopene/day.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Measure carotenoids, including lycopene and its isomers, in blood (umol/L) and prostate tissue (nmol/g) of men after three weeks of consuming V8 vegetable juice, condensed tomato soup or tomato sauce.
Tidsramme: Day 0 and End of Study (an average of 23 days)
|
Day 0 and End of Study (an average of 23 days)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Measure histobiomarkers in the prostate related to aggressive disease including Gleason Grade (number 1 - 10), tumor volume (weight) , and vascular endothelial growth factor expression (ng/mL)
Tidsramme: Day 0 and End of Study (an average of 23 days)
|
Measure histobiomarkers in the prostate related to aggressive disease including Gleason Grade, tumor volume, and vascular endothelial growth factor expression
|
Day 0 and End of Study (an average of 23 days)
|
|
Measure biomarkers related to prostate cancer in controls and men consuming tomato food products prior to surgery. These biomarkers include plasma insulin like growth factor (ng/mL) and plasma prostate specific antigen (ng/mL)
Tidsramme: Day 0 and End of study (an average of 23 days)
|
Measure biomarkers related to prostate cancer in controls and men consuming tomato food products prior to surgery.
These biomarkers include plasma insulin like growth factor (ng/mL) and plasma prostate specific antigen (ng/mL)
|
Day 0 and End of study (an average of 23 days)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Steven Clinton, MD, The Ohio State University Comprehensive Cancer Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
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. maj 2002
Primær færdiggørelse (Faktiske)
1. oktober 2004
Studieafslutning (Faktiske)
1. oktober 2004
Datoer for studieregistrering
Først indsendt
31. oktober 2014
Først indsendt, der opfyldte QC-kriterier
12. november 2014
Først opslået (Skøn)
17. november 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
17. november 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. november 2014
Sidst verificeret
1. november 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- OSU-0137
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 .