Clinical trial · Interventional
Aborption and Metabolism of Lyophilized Black Raspberry Food Products in Men With Prostate Cancer Undergoing Surgery
Dietary Fruit Bioactives and Prostate Cancer
NCT01823562CI-TRIAL-00112149completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IIA Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dietary intervention | Dietary Supplement | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| lyophilized black raspberry confection | Drug | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- type
- ACTIVE_COMPARATOR
- label
- Arm I (regular diet)
- description
- Patients follow a regular diet for 4-6 weeks and then undergo prostatectomy.
- interventionNames
- Other: laboratory biomarker analysis
- Procedure: quality-of-life assessment
- Other: questionnaire administration
- type
- ACTIVE_COMPARATOR
- label
- Arm II (low polyphenol diet)
- description
- Patients follow a low polyphenol diet for 4-6 weeks and then undergo prostatectomy.
- interventionNames
- Other: laboratory biomarker analysis
- Dietary Supplement: dietary intervention
- Procedure: quality-of-life assessment
- Other: questionnaire administration
- type
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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)
References
Publications (3)
- BACKGROUNDHill 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. PMID 33744235
- RESULTRoberts 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. PMID 27813248
- RESULTRoberts 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. PMID 32112501