Stage I Prostate CancerPhase 1NCT01823562
Aborption and Metabolism of Lyophilized Black Raspberry Food Products in Men With Prostate Cancer Undergoing Surgery
A Phase 1 study testing lyophilized black raspberry confection, laboratory biomarker analysis and dietary intervention in people with Stage I Prostate Cancer and Stage IIA Prostate Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This Phase I/Ib trial is studying the absorption and metabolism of phytochemicals found in black raspberries in men undergoing surgery for prostate cancer. This knowledge will help us design future chemoprevention studies and assist in making future dietary recommendations for men at high risk for prostate cancer. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer
- What is being tested?
- lyophilized black raspberry confection, laboratory biomarker analysis and dietary intervention
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2012to 12 Nov 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have biopsy proven carcinoma of the prostate
- Have chosen a radical prostatectomy for treatment of their disease after the medical team has presented all possible treatment options
- Not be receiving neoadjuvant hormonal or chemotherapy (other clinical trials)
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Not currently taking berry dietary supplements, or "alternative" products (Acai berry, pomegranate, black raspberry, Optiberry, Juice Plus)
- Have BUN/Cr (blood urea nitrogen and serum creatinine) within normal limits
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- Have liver enzymes within normal limits
- Have complete blood count (CBC) within normal limits
- Have prothrombin time/partial thromboplastin time (PT/PTT/INR) within normal limits
- Voluntarily agree to participate and sign an informed consent document
- Agree to have prostate biopsy blocks provided to the study for evaluation
- Agree to consume a standardized vitamin and mineral supplement and avoid other nutrition, dietary, or alternative medications/supplements for the duration of the study
- Agree to follow a controlled polyphenolic and/ or ellagitannin diet
Who cannot join
- Have an active malignancy other than prostate cancer that requires therapy
- Have a prostate biopsy with less than 5% cancer involvement
- Have a history of traumatic or surgical castration
- Have a history of pituitary hormone diseases that currently require supplemental hormonal administration (thyroid hormones, adrenocorticotropic hormone [ACTH], growth hormone) or other endocrine disorders requiring hormone administration with the exception of diabetes and osteoporosis
- Are taking certain medications; no concurrent finasteride (Proscar) or other hormonal agents for chemoprevention/treatment of benign prostate hyperplasia (BPH); utilizing prescription medications for urinary outlet obstructive symptoms will not be permitted; the use of non-prescription substances to improve urinary tract symptoms will not be permitted (i.e. Saw Palmetto, other herbal, alternative products)
- Have a known allergy to black raspberries, corn, and wheat products or those who have never consumed any of these products
Show all 12Show fewer
- Have active metabolic or digestive illnesses such as malabsorptive disorders (Crohn's, Celiac disease, irritable bowel syndrome [IBS]), renal insufficiency, hepatic insufficiency, cachexia, or short bowel syndrome
- Have significant loss of gastrointestinal organs due to surgery, except for appendix
- Have altered immunity such as autoimmune disorders, cancer, anemia, hemophilia, and blood dyscrasias
- Have noticeable open lesions in the oral cavity, sores that have not healed for more than 2 months or have a history of leukoplakia, tumors of the buccal cavity, throat, and lips
- Have difficulty swallowing (dysphagia), pain with swallowing (odynophagia), salivary gland dysfunction, or xerostomia (dry mouth)
- Are taking medications that inhibit clotting (warfarin sodium) or using prescribed oral rinses (Peridex)
Trial locations and contacts
1 site in 1 country.
United States1 site
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: Dietary Fruit Bioactives and Prostate Cancer
This Phase I/Ib trial is studying the absorption and metabolism of phytochemicals found in black raspberries in men undergoing surgery for prostate cancer. This knowledge will help us design future chemoprevention studies and assist in making future dietary recommendations for men at high risk for prostate cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To conduct a dose-escalation study to determine safety and compliance of varying lyophilized black raspberry (LBR) delivery vehicles (a confection and a nectar) at two different doses.
SECONDARY OBJECTIVES:
- To precisely quantify changes in the content and distribution of black raspberry phytochemicals and their metabolites in the blood and urine and correlate these concentrations with prostate tissue phytochemicals.
II. Measure the ability of black raspberry gummy confection and nectar in altering hormonal patterns (lower insulin-like growth factor-1 [IGF-I], higher insulin-like growth factor-binding protein 3 [IGF-BP3], lower androgens) consistent with reduced prostate carcinogenesis and in parallel with an enhanced capacity to quench reactive oxygen.
III. Investigate histopathologic, immunologic, and molecular biomarkers associated with prostate carcinogenesis that may serve as surrogate endpoint biomarkers and provide information regarding their ability to be modulated by black raspberries.
IV. Determine if consumption of black raspberries alters molecular markers in the human prostate including: (a) neuroendocrine markers such as IGF-I and IGF-BP3, (b) signal transduction markers such as phosphatase and tensin homologue (PTEN) and phospho-AKT, and (c) angiogenesis regulators such as (vascular epithelial growth factor (VEGF).
- Collect and store plasma and peripheral blood mononuclear cells (PBMCs) from each patient to assess systemic markers of inflammation and immune response.
OUTLINE: This is a dose-escalation study of lyophilized black raspberry gummy confection and nectar. Patients are assigned to 1 of 7 treatment arms.
ARM I: Patients follow a regular diet for 4-6 weeks and then undergo prostatectomy.
ARM II: Patients follow a low polyphenol diet for 4-6 weeks and then undergo prostatectomy.
ARM III: Patients follow a low ellagitannin diet for 4-6 weeks and then undergo prostatectomy.
ARM IV: Patients follow a low ellagitannin diet and consume a lower-dose black raspberry confection daily for 4-6 weeks and then undergo prostatectomy.
ARM V: Patients follow a low ellagitannin diet and consume a higher-dose black raspberry confection daily for 4-6 weeks and then undergo prostatectomy.
ARM VI: Patients follow a low ellagitannin diet and consume a lower-dose black raspberry nectar daily for 4-6 weeks and then undergo prostatectomy.
ARM VII: Patients follow a low ellagitannin diet and consume a higher-dose black raspberry nectar daily for 4-6 weeks and then undergo prostatectomy.
- Conditions
- Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer
- Being tested
- lyophilized black raspberry confection, laboratory biomarker analysis, dietary intervention, quality-of-life assessment, questionnaire administration
- Keywords
- Lyophilized Black Raspberry, Prostate Cancer, Polyphenols
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lyophilized black raspberry confectionDrug
Also called LBR confection
Given PO
laboratory biomarker analysisOther
Correlative studies
dietary interventionDietary supplement
Also called Dietary Modification, intervention, dietary
Follow a low polyphenol diet
dietary interventionDietary supplement
Also called Dietary Modification, intervention, dietary
Follow a low ellagitannin diet
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (regular diet) | Active comparator | Patients follow a regular diet for 4-6 weeks and then undergo prostatectomy. Receives: Other: laboratory biomarker analysis; Procedure: quality-of-life assessment; Other: questionnaire administration |
| Arm II (low polyphenol diet) | Active comparator | Patients follow a low polyphenol diet for 4-6 weeks and then undergo prostatectomy. Receives: Other: laboratory biomarker analysis; Dietary Supplement: dietary intervention; Procedure: quality-of-life assessment; Other: questionnaire administration |
| Arm III (low ellagitannin diet) | Active comparator | Patients follow a low ellagitannin diet for 4-6 weeks and then undergo prostatectomy. Receives: Other: laboratory biomarker analysis; Dietary Supplement: dietary intervention; Procedure: quality-of-life assessment; Other: questionnaire administration |
| Arm IV (lower-dose lyophilized black raspberry confection) | Experimental | Patients follow a low ellagitannin diet and receive lower-dose black raspberry confection each day for 4-6 weeks and then undergo prostatectomy. Receives: Drug: lyophilized black raspberry confection; Other: laboratory biomarker analysis; Dietary Supplement: dietary intervention; Procedure: quality-of-life assessment; Other: questionnaire administration |
| Arm V (higher-dose black raspberry confection) | Experimental | Patients follow a low ellagitannin diet and receive higher-dose black raspberry confection to consume orally each day for 4-6 weeks and then undergo prostatectomy. Receives: Drug: lyophilized black raspberry confection; Other: laboratory biomarker analysis; Dietary Supplement: dietary intervention; Procedure: quality-of-life assessment; Other: questionnaire administration |
| Arm VI (lower-dose black raspberry nectar) | Experimental | Patients follow a low ellagitannin diet and receive lower-dose black raspberry nectar for oral consumption daily for 4-6 weeks and then undergo prostatectomy. Receives: Drug: lyophilized black raspberry confection; Other: laboratory biomarker analysis; Dietary Supplement: dietary intervention; Procedure: quality-of-life assessment; Other: questionnaire administration |
| Arm VII (higher-dose black raspberry nectar) | Experimental | Patients follow a low ellagitannin diet and receive higher-dose black raspberry nectar for oral consumption daily for 4-6 weeks and then undergo prostatectomy. Receives: Drug: lyophilized black raspberry confection; Other: laboratory biomarker analysis; Dietary Supplement: dietary intervention; Procedure: quality-of-life assessment; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events Assessed Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Adverse events were measured by asking participants at each study visit about any new symptoms which may or may not be related to the intervention. No adverse events were reported from any subjects.
Measured: Up to 30 days after completion of study treatment
Percentage of Intervention Consumed
A cohort will be considered compliant if the group mean consumption of the intervention product is at least 80%.
Measured: Up to 6-weeks
Secondary outcomes (3)
Concentration of Black Raspberry Metabolites in the Urine Collected 24 Hours Before Surgery
At the baseline enrollment, subjects provided a spot urine sample. One day prior to surgery, subjects collected a 24-h urine sample. Spot urine samples were used to estimate individual ET exposure at baseline, but not specifically for comparison to 24-h urine sample collection at the close of the intervention. UPLC eluate was introduced to a triple quadrupole mass spectrometer (QuattroUltima,Waters Corp., Beverley,MA) via an electrospray mode operated in positive ion mode without splitting flow. Standards of urolithin A, B, C, D, methyl A, and dimethyl A were used for external calibration. Baseline urine analysis was determined from a spot urine collection and metabolite profiles were normalized to urinary creatinine levels. Final urinary analysis was based on a 24-h urine collection and metabolite profiles were normalized to 24-h urine volumes.
Measured: 24 hours
Changes in PSA or PSA Doubling Time
Analyzed on the log scale using a repeated measures linear model to judge the effect of treatment group in terms of fold-differences from baseline while controlling for BMI and age. Confidence intervals for dichotomous variables will be made using exact methods and confidence intervals for rank correlations between quantitative variables will be made using Fisher's transformation.
Measured: Up to 6 weeks
Black Raspberry Metabolites Levels in the Prostate Tissue Removed at Surgery
Confidence intervals for dichotomous variables will be made using exact methods and confidence intervals for rank correlations between quantitative variables will be made using Fisher's transformation.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study start17 Oct 2012
- Primary completion1 Aug 2013
- Study completion12 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stage I Prostate CancerStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Clinton, Ohio State University Comprehensive Cancer Center
- Investigators
- Steven Clinton, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823562
- Sponsor's protocol ID
- OSU-12125
- Other IDs
- NCI-2013-00326
- Status last verified
- Apr 2026
- First submitted
- 28 Mar 2013
- Last updated
- 20 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hill EB, Kennedy AJ, Roberts KM, Riedl KM, Grainger EM, Clinton SK. Considerations for Use of the Phenol-Explorer Database to Estimate Dietary (Poly)phenol Intake. J Acad Nutr Diet. 2021 May;121(5):833-834. doi: 10.1016/j.jand.2021.02.010. Epub 2021 Mar 17. No abstract available.
PubMed 33744235Roberts KM, Grainger EM, Thomas-Ahner JM, Hinton A, Gu J, Riedl KM, Vodovotz Y, Abaza R, Schwartz SJ, Clinton SK. Application of a low polyphenol or low ellagitannin dietary intervention and its impact on ellagitannin metabolism in men. Mol Nutr Food Res. 2017 Mar;61(3):10.1002/mnfr.201600224. doi: 10.1002/mnfr.201600224. Epub 2017 Jan 17.
PubMed 27813248Roberts KM, Grainger EM, Thomas-Ahner JM, Hinton A, Gu J, Riedl K, Vodovotz Y, Abaza R, Schwartz SJ, Clinton SK. Dose-Dependent Increases in Ellagitannin Metabolites as Biomarkers of Intake in Humans Consuming Standardized Black Raspberry Food Products Designed for Clinical Trials. Mol Nutr Food Res. 2020 May;64(10):e1900800. doi: 10.1002/mnfr.201900800. Epub 2020 Mar 17.
PubMed 32112501
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Fruit Bioactives and Prostate Cancer
- ClinicalTrials.gov ID
- NCT01823562
- Acronym / sponsor ID
- OSU-12125
- Conditions
- Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer
- Keywords
- Lyophilized Black Raspberry, Prostate Cancer, Polyphenols
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 17 Oct 2012 (actual)
- Primary completion
- 1 Aug 2013 (actual)
- Study completion
- 12 Nov 2025 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Posted 20 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase I/Ib trial is studying the absorption and metabolism of phytochemicals found in black raspberries in men undergoing surgery for prostate cancer. This knowledge will help us design future chemoprevention studies and assist in making future dietary recommendations for men at high risk for prostate cancer.
Detailed description
PRIMARY OBJECTIVES:
- To conduct a dose-escalation study to determine safety and compliance of varying lyophilized black raspberry (LBR) delivery vehicles (a confection and a nectar) at two different doses.
SECONDARY OBJECTIVES:
- To precisely quantify changes in the content and distribution of black raspberry phytochemicals and their metabolites in the blood and urine and correlate these concentrations with prostate tissue phytochemicals.
II. Measure the ability of black raspberry gummy confection and nectar in altering hormonal patterns (lower insulin-like growth factor-1 [IGF-I], higher insulin-like growth factor-binding protein 3 [IGF-BP3], lower androgens) consistent with reduced prostate carcinogenesis and in parallel with an enhanced capacity to quench reactive oxygen.
III. Investigate histopathologic, immunologic, and molecular biomarkers associated with prostate carcinogenesis that may serve as surrogate endpoint biomarkers and provide information regarding their ability to be modulated by black raspberries.
IV. Determine if consumption of black raspberries alters molecular markers in the human prostate including: (a) neuroendocrine markers such as IGF-I and IGF-BP3, (b) signal transduction markers such as phosphatase and tensin homologue (PTEN) and phospho-AKT, and (c) angiogenesis regulators such as (vascular epithelial growth factor (VEGF).
- Collect and store plasma and peripheral blood mononuclear cells (PBMCs) from each patient to assess systemic markers of inflammation and immune response.
OUTLINE: This is a dose-escalation study of lyophilized black raspberry gummy confection and nectar. Patients are assigned to 1 of 7 treatment arms.
ARM I: Patients follow a regular diet for 4-6 weeks and then undergo prostatectomy.
ARM II: Patients follow a low polyphenol diet for 4-6 weeks and then undergo prostatectomy.
ARM III: Patients follow a low ellagitannin diet for 4-6 weeks and then undergo prostatectomy.
ARM IV: Patients follow a low ellagitannin diet and consume a lower-dose black raspberry confection daily for 4-6 weeks and then undergo prostatectomy.
ARM V: Patients follow a low ellagitannin diet and consume a higher-dose black raspberry confection daily for 4-6 weeks and then undergo prostatectomy.
ARM VI: Patients follow a low ellagitannin diet and consume a lower-dose black raspberry nectar daily for 4-6 weeks and then undergo prostatectomy.
ARM VII: Patients follow a low ellagitannin diet and consume a higher-dose black raspberry nectar daily for 4-6 weeks and then undergo prostatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Arm I (regular diet) | Active comparator | Other: laboratory biomarker analysis, Procedure: quality-of-life assessment, Other: questionnaire administrationPatients follow a regular diet for 4-6 weeks and then undergo prostatectomy. |
| Arm II (low polyphenol diet) | Active comparator | Other: laboratory biomarker analysis, Dietary Supplement: dietary intervention, Procedure: quality-of-life assessment, Other: questionnaire administrationPatients follow a low polyphenol diet for 4-6 weeks and then undergo prostatectomy. |
| Arm III (low ellagitannin diet) | Active comparator | Other: laboratory biomarker analysis, Dietary Supplement: dietary intervention, Procedure: quality-of-life assessment, Other: questionnaire administrationPatients follow a low ellagitannin diet for 4-6 weeks and then undergo prostatectomy. |
| Arm IV (lower-dose lyophilized black raspberry confection) | Experimental | Drug: lyophilized black raspberry confection, Other: laboratory biomarker analysis, Dietary Supplement: dietary intervention, Procedure: quality-of-life assessment, Other: questionnaire administrationPatients follow a low ellagitannin diet and receive lower-dose black raspberry confection each day for 4-6 weeks and then undergo prostatectomy. |
| Arm V (higher-dose black raspberry confection) | Experimental | Drug: lyophilized black raspberry confection, Other: laboratory biomarker analysis, Dietary Supplement: dietary intervention, Procedure: quality-of-life assessment, Other: questionnaire administrationPatients follow a low ellagitannin diet and receive higher-dose black raspberry confection to consume orally each day for 4-6 weeks and then undergo prostatectomy. |
| Arm VI (lower-dose black raspberry nectar) | Experimental | Drug: lyophilized black raspberry confection, Other: laboratory biomarker analysis, Dietary Supplement: dietary intervention, Procedure: quality-of-life assessment, Other: questionnaire administrationPatients follow a low ellagitannin diet and receive lower-dose black raspberry nectar for oral consumption daily for 4-6 weeks and then undergo prostatectomy. |
| Arm VII (higher-dose black raspberry nectar) | Experimental | Drug: lyophilized black raspberry confection, Other: laboratory biomarker analysis, Dietary Supplement: dietary intervention, Procedure: quality-of-life assessment, Other: questionnaire administrationPatients follow a low ellagitannin diet and receive higher-dose black raspberry nectar for oral consumption daily for 4-6 weeks and then undergo prostatectomy. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Have biopsy proven carcinoma of the prostate
- Have chosen a radical prostatectomy for treatment of their disease after the medical team has presented all possible treatment options
- Not be receiving neoadjuvant hormonal or chemotherapy (other clinical trials)
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Not currently taking berry dietary supplements, or "alternative" products (Acai berry, pomegranate, black raspberry, Optiberry, Juice Plus)
Key exclusion criteria (12 listed)
- Have an active malignancy other than prostate cancer that requires therapy
- Have a prostate biopsy with less than 5% cancer involvement
- Have a history of traumatic or surgical castration
- Have a history of pituitary hormone diseases that currently require supplemental hormonal administration (thyroid hormones, adrenocorticotropic hormone [ACTH], growth hormone) or other endocrine disorders requiring hormone administration with the exception of diabetes and osteoporosis
- Are taking certain medications; no concurrent finasteride (Proscar) or other hormonal agents for chemoprevention/treatment of benign prostate hyperplasia (BPH); utilizing prescription medications for urinary outlet obstructive symptoms will not be permitted; the use of non-prescription substances to improve urinary tract symptoms will not be permitted (i.e. Saw Palmetto, other herbal, alternative products)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lyophilized black raspberry confectionAlso: LBR confectionGiven PO | Drug | Arm IV (lower-dose lyophilized black raspberry confection), Arm V (higher-dose black raspberry confection), Arm VI (lower-dose black raspberry nectar), Arm VII (higher-dose black raspberry nectar) |
| laboratory biomarker analysisCorrelative studies | Other | Arm I (regular diet), Arm II (low polyphenol diet), Arm III (low ellagitannin diet), Arm IV (lower-dose lyophilized black raspberry confection), Arm V (higher-dose black raspberry confection), Arm VI (lower-dose black raspberry nectar), Arm VII (higher-dose black raspberry nectar) |
| dietary interventionAlso: Dietary Modification, intervention, dietaryFollow a low polyphenol diet | Dietary supplement | Arm II (low polyphenol diet) |
| dietary interventionAlso: Dietary Modification, intervention, dietaryFollow a low ellagitannin diet | Dietary supplement | Arm III (low ellagitannin diet), Arm IV (lower-dose lyophilized black raspberry confection), Arm V (higher-dose black raspberry confection), Arm VI (lower-dose black raspberry nectar), Arm VII (higher-dose black raspberry nectar) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Arm I (regular diet), Arm II (low polyphenol diet), Arm III (low ellagitannin diet), Arm IV (lower-dose lyophilized black raspberry confection), Arm V (higher-dose black raspberry confection), Arm VI (lower-dose black raspberry nectar), Arm VII (higher-dose black raspberry nectar) |
| questionnaire administrationAncillary studies | Other | Arm I (regular diet), Arm II (low polyphenol diet), Arm III (low ellagitannin diet), Arm IV (lower-dose lyophilized black raspberry confection), Arm V (higher-dose black raspberry confection), Arm VI (lower-dose black raspberry nectar), Arm VII (higher-dose black raspberry nectar) |
Primary outcome
Adverse Events Assessed Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Time frame: Up to 30 days after completion of study treatment
Adverse events were measured by asking participants at each study visit about any new symptoms which may or may not be related to the intervention. No adverse events were reported from any subjects.
Percentage of Intervention Consumed
Time frame: Up to 6-weeks
A cohort will be considered compliant if the group mean consumption of the intervention product is at least 80%.
3 secondary outcomes
Concentration of Black Raspberry Metabolites in the Urine Collected 24 Hours Before Surgery
Time frame: 24 hours
Changes in PSA or PSA Doubling Time
Time frame: Up to 6 weeks
Black Raspberry Metabolites Levels in the Prostate Tissue Removed at Surgery
Time frame: Up to 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33744235Hill EB, Kennedy AJ, Roberts KM, Riedl KM, Grainger EM, Clinton SK. Considerations for Use of the Phenol-Explorer Database to Estimate Dietary (Poly)phenol Intake. J Acad Nutr Diet. 2021 May;121(5):833-834. doi: 10.1016/j.jand.2021.02.010. Epub 2021 Mar 17. No abstract available.
- Results publication: PubMed 27813248Roberts KM, Grainger EM, Thomas-Ahner JM, Hinton A, Gu J, Riedl KM, Vodovotz Y, Abaza R, Schwartz SJ, Clinton SK. Application of a low polyphenol or low ellagitannin dietary intervention and its impact on ellagitannin metabolism in men. Mol Nutr Food Res. 2017 Mar;61(3):10.1002/mnfr.201600224. doi: 10.1002/mnfr.201600224. Epub 2017 Jan 17.
- Results publication: PubMed 32112501Roberts KM, Grainger EM, Thomas-Ahner JM, Hinton A, Gu J, Riedl K, Vodovotz Y, Abaza R, Schwartz SJ, Clinton SK. Dose-Dependent Increases in Ellagitannin Metabolites as Biomarkers of Intake in Humans Consuming Standardized Black Raspberry Food Products Designed for Clinical Trials. Mol Nutr Food Res. 2020 May;64(10):e1900800. doi: 10.1002/mnfr.201900800. Epub 2020 Mar 17.
- The JameslineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Clinton principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lyophilized black raspberry confection, laboratory biomarker analysis and dietary intervention in people with Stage I Prostate Cancer and Stage IIA Prostate Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events Assessed Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (time frame: Up to 30 days after completion of study treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01823562, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.