Aborption and Metabolism of Lyophilized Black Raspberry Food Products in Men With Prostate Cancer Undergoing Surgery
April 27, 2026 updated by: Steven Clinton, Ohio State University Comprehensive Cancer Center
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.
Study Overview
Status
Completed
Conditions
Detailed Description
PRIMARY OBJECTIVES:
I. 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:
I. 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).
V. 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 Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Arm I (regular diet)
Patients follow a regular diet for 4-6 weeks and then undergo prostatectomy.
|
Correlative studies
Ancillary studies
Ancillary studies
Other Names:
|
|
Active Comparator: Arm II (low polyphenol diet)
Patients follow a low polyphenol diet for 4-6 weeks and then undergo prostatectomy.
|
Correlative studies
Ancillary studies
Ancillary studies
Other Names:
Follow a low polyphenol diet
Other Names:
Follow a low ellagitannin diet
Other Names:
|
|
Active Comparator: Arm III (low ellagitannin diet)
Patients follow a low ellagitannin diet for 4-6 weeks and then undergo prostatectomy.
|
Correlative studies
Ancillary studies
Ancillary studies
Other Names:
Follow a low polyphenol diet
Other Names:
Follow a low ellagitannin diet
Other Names:
|
|
Experimental: Arm IV (lower-dose lyophilized black raspberry confection)
Patients follow a low ellagitannin diet and receive lower-dose black raspberry confection each day for 4-6 weeks and then undergo prostatectomy.
|
Correlative studies
Ancillary studies
Ancillary studies
Other Names:
Follow a low polyphenol diet
Other Names:
Follow a low ellagitannin diet
Other Names:
Given PO
Other Names:
|
|
Experimental: Arm V (higher-dose black raspberry confection)
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.
|
Correlative studies
Ancillary studies
Ancillary studies
Other Names:
Follow a low polyphenol diet
Other Names:
Follow a low ellagitannin diet
Other Names:
Given PO
Other Names:
|
|
Experimental: Arm VI (lower-dose black raspberry nectar)
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.
|
Correlative studies
Ancillary studies
Ancillary studies
Other Names:
Follow a low polyphenol diet
Other Names:
Follow a low ellagitannin diet
Other Names:
Given PO
Other Names:
|
|
Experimental: Arm VII (higher-dose black raspberry nectar)
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.
|
Correlative studies
Ancillary studies
Ancillary studies
Other Names:
Follow a low polyphenol diet
Other Names:
Follow a low ellagitannin diet
Other Names:
Given PO
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Up to 30 days after completion of study treatment
|
|
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%.
|
Up to 6-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Concentration of Black Raspberry Metabolites in the Urine Collected 24 Hours Before Surgery
Time Frame: 24 hours
|
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.
|
24 hours
|
|
Changes in PSA or PSA Doubling Time
Time Frame: Up to 6 weeks
|
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.
|
Up to 6 weeks
|
|
Black Raspberry Metabolites Levels in the Prostate Tissue Removed at Surgery
Time Frame: Up to 6 weeks
|
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.
|
Up to 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Steven Clinton, Ohio State University Comprehensive Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Roberts 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.
- Roberts 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 17, 2012
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
November 12, 2025
Study Registration Dates
First Submitted
March 28, 2013
First Submitted That Met QC Criteria
April 2, 2013
First Posted (Estimated)
April 4, 2013
Study Record Updates
Last Update Posted (Actual)
May 20, 2026
Last Update Submitted That Met QC Criteria
April 27, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSU-12125
- NCI-2013-00326 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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