Trial Outcomes & Findings for Aborption and Metabolism of Lyophilized Black Raspberry Food Products in Men With Prostate Cancer Undergoing Surgery (NCT NCT01823562)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

60 participants

Primary outcome timeframe

Up to 30 days after completion of study treatment

Results posted on

2026-05-20

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Regular Diet) Patients follow a regular diet for 4-6 weeks and then undergo prostatectomy. laboratory biomarker analysis: Correlative studies quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm II (Low Polyphenol Diet) Patients follow a low polyphenol diet for 4-6 weeks and then undergo prostatectomy. laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low polyphenol diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm III (Low Ellagitannin Diet) Patients follow a low ellagitannin diet for 4-6 weeks and then undergo prostatectomy. laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm IV (Lower-dose Lyophilized Black Raspberry Gummy) Patients follow a low ellagitannin diet and receive lower-dose black raspberry nectar PO daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry nectar: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm V (Higher-dose Black Raspberry Gummy) Patients follow a low ellagitannin diet and receive higher-dose black raspberry nectar PO daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry nectar: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm VI (Lower-dose Black Raspberry Confection) Patients follow a low ellagitannin diet and receive lower-dose black raspberry confection PO daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm VII (Higher-dose Black Raspberry Confection) Patients follow a low ellagitannin diet and receive higher-dose black raspberry confection PO daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies
Overall Study STARTED	9	9	9	9	8	8	8
Overall Study COMPLETED	8	8	8	8	8	8	8
Overall Study NOT COMPLETED	1	1	1	1	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Aborption and Metabolism of Lyophilized Black Raspberry Food Products in Men With Prostate Cancer Undergoing Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Regular Diet) n=8 Participants Patients follow a regular diet for 4-6 weeks and then undergo prostatectomy. laboratory biomarker analysis: Correlative studies quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm II (Low Polyphenol Diet) n=8 Participants Patients follow a low polyphenol diet for 4-6 weeks and then undergo prostatectomy. laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low polyphenol diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm III (Low Ellagitannin Diet) n=8 Participants Patients follow a low ellagitannin diet for 4-6 weeks and then undergo prostatectomy. laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm IV (Lower-dose Lyophilized Black Raspberry Gummy) n=8 Participants Patients follow a low ellagitannin diet and receive lower-dose black raspberry nectar PO daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry nectar: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm V (Higher-dose Black Raspberry Gummy) n=8 Participants Patients follow a low ellagitannin diet and receive higher-dose black raspberry nectar PO daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry nectar: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm VI (Lower-dose Black Raspberry Confection) n=8 Participants Patients follow a low ellagitannin diet and receive lower-dose black raspberry confection PO daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm VII (Higher-dose Black Raspberry Confection) n=8 Participants Patients follow a low ellagitannin diet and receive higher-dose black raspberry confection PO daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Total n=56 Participants Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 7 • n=30 Participants	65 years STANDARD_DEVIATION 8 • n=30 Participants	62 years STANDARD_DEVIATION 7 • n=60 Participants	58 years STANDARD_DEVIATION 6 • n=133 Participants	60 years STANDARD_DEVIATION 8 • n=6 Participants	59 years STANDARD_DEVIATION 6	62 years STANDARD_DEVIATION 6	62 years STANDARD_DEVIATION 3 • n=71 Participants
Sex: Female, Male Female	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants	0 Participants n=133 Participants	0 Participants n=6 Participants	0 Participants	0 Participants	0 Participants n=71 Participants
Sex: Female, Male Male	8 Participants n=30 Participants	8 Participants n=30 Participants	8 Participants n=60 Participants	8 Participants n=133 Participants	8 Participants n=6 Participants	8 Participants	8 Participants	56 Participants n=71 Participants
Region of Enrollment United States	8 participants n=30 Participants	8 participants n=30 Participants	8 participants n=60 Participants	8 participants n=133 Participants	8 participants n=6 Participants	8 participants	8 participants	56 participants n=71 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arm I (Regular Diet) n=8 Participants Patients follow a regular diet for 4-6 weeks and then undergo prostatectomy. laboratory biomarker analysis: Correlative studies quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm II (Low Polyphenol Diet) n=8 Participants Patients follow a low polyphenol diet for 4-6 weeks and then undergo prostatectomy. laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low polyphenol diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm III (Low Ellagitannin Diet) n=8 Participants Patients follow a low ellagitannin diet for 4-6 weeks and then undergo prostatectomy. laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm IV (Lower-dose Lyophilized Black Raspberry Confection) n=8 Participants Patients follow a low ellagitannin diet and receive lower-dose black raspberry confection each day for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm V (Higher-dose Black Raspberry Confection) n=8 Participants 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. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm VI (Lower-dose Black Raspberry Nectar) n=8 Participants 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. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm VII (Higher-dose Black Raspberry Nectar) n=8 Participants 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. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies
Adverse Events Assessed Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 6-weeks

A cohort will be considered compliant if the group mean consumption of the intervention product is at least 80%.

Outcome measures

Outcome measures
Measure	Arm I (Regular Diet) n=8 Participants Patients follow a regular diet for 4-6 weeks and then undergo prostatectomy. laboratory biomarker analysis: Correlative studies quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm II (Low Polyphenol Diet) n=8 Participants Patients follow a low polyphenol diet for 4-6 weeks and then undergo prostatectomy. laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low polyphenol diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm III (Low Ellagitannin Diet) n=8 Participants Patients follow a low ellagitannin diet for 4-6 weeks and then undergo prostatectomy. laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm IV (Lower-dose Lyophilized Black Raspberry Confection) n=8 Participants Patients follow a low ellagitannin diet and receive lower-dose black raspberry confection each day for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm V (Higher-dose Black Raspberry Confection) n=8 Participants 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. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm VI (Lower-dose Black Raspberry Nectar) n=8 Participants 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. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm VII (Higher-dose Black Raspberry Nectar) n=8 Participants 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. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies
Percentage of Intervention Consumed	100 Percentage of intervention consumed Interval 100.0 to 100.0	95 Percentage of intervention consumed Interval 90.0 to 100.0	100 Percentage of intervention consumed Interval 98.0 to 100.0	96 Percentage of intervention consumed Interval 90.0 to 100.0	100 Percentage of intervention consumed Interval 98.0 to 100.0	100 Percentage of intervention consumed Interval 95.0 to 100.0	100 Percentage of intervention consumed Interval 96.0 to 100.0

SECONDARY outcome

Timeframe: 24 hours

Population: We did not collect a 24 hour urine from men enrolled in the first two groups (regular diet and low polyphenol diet)

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.

Outcome measures

Outcome measures
Measure	Arm I (Regular Diet) n=8 Participants Patients follow a regular diet for 4-6 weeks and then undergo prostatectomy. laboratory biomarker analysis: Correlative studies quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm II (Low Polyphenol Diet) n=8 Participants Patients follow a low polyphenol diet for 4-6 weeks and then undergo prostatectomy. laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low polyphenol diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm III (Low Ellagitannin Diet) n=8 Participants Patients follow a low ellagitannin diet for 4-6 weeks and then undergo prostatectomy. laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm IV (Lower-dose Lyophilized Black Raspberry Confection) n=8 Participants Patients follow a low ellagitannin diet and receive lower-dose black raspberry confection each day for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm V (Higher-dose Black Raspberry Confection) n=8 Participants 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. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	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. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	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. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies
Concentration of Black Raspberry Metabolites in the Urine Collected 24 Hours Before Surgery	0.08 Urolithin A in 24 hour urine (nmol/day) Interval 0.0 to 0.6	2371 Urolithin A in 24 hour urine (nmol/day) Interval 982.0 to 3139.0	6480 Urolithin A in 24 hour urine (nmol/day) Interval 0.0 to 11754.0	4975 Urolithin A in 24 hour urine (nmol/day) Interval 1217.0 to 6496.0	7211 Urolithin A in 24 hour urine (nmol/day) Interval 174.0 to 12107.0	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arm I (Regular Diet) n=8 Participants Patients follow a regular diet for 4-6 weeks and then undergo prostatectomy. laboratory biomarker analysis: Correlative studies quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm II (Low Polyphenol Diet) n=8 Participants Patients follow a low polyphenol diet for 4-6 weeks and then undergo prostatectomy. laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low polyphenol diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm III (Low Ellagitannin Diet) n=8 Participants Patients follow a low ellagitannin diet for 4-6 weeks and then undergo prostatectomy. laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm IV (Lower-dose Lyophilized Black Raspberry Confection) n=8 Participants Patients follow a low ellagitannin diet and receive lower-dose black raspberry confection each day for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm V (Higher-dose Black Raspberry Confection) n=8 Participants 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. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm VI (Lower-dose Black Raspberry Nectar) n=8 Participants 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. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm VII (Higher-dose Black Raspberry Nectar) n=8 Participants 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. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies
Changes in PSA or PSA Doubling Time	6.08 PSA ng/mL Standard Deviation 3.34	6.19 PSA ng/mL Standard Deviation 1.64	4.56 PSA ng/mL Standard Deviation 2.4	4.57 PSA ng/mL Standard Deviation 2.23	6.35 PSA ng/mL Standard Deviation 1.88	6.05 PSA ng/mL Standard Deviation 3.06	5.63 PSA ng/mL Standard Deviation 2.63

SECONDARY outcome

Timeframe: Up to 6 weeks

Population: We were only able to obtain enough prostate tissue for ellagitannin metabolite analysis in 8 men (4 subjects on the usual diet arm and 4 who were consuming the black raspberry food products). No metabolites were detected in any of the prostate tissue samples.

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.

Outcome measures

Outcome measures
Measure	Arm I (Regular Diet) n=4 Participants Patients follow a regular diet for 4-6 weeks and then undergo prostatectomy. laboratory biomarker analysis: Correlative studies quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm II (Low Polyphenol Diet) Patients follow a low polyphenol diet for 4-6 weeks and then undergo prostatectomy. laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low polyphenol diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm III (Low Ellagitannin Diet) Patients follow a low ellagitannin diet for 4-6 weeks and then undergo prostatectomy. laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	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. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	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. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm VI (Lower-dose Black Raspberry Nectar) n=1 Participants 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. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Arm VII (Higher-dose Black Raspberry Nectar) n=3 Participants 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. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies
Black Raspberry Metabolites Levels in the Prostate Tissue Removed at Surgery	0 nmol/g of prostate tissue Interval 0.0 to 0.0	—	—	—	—	0 nmol/g of prostate tissue Interval 0.0 to 0.0	0 nmol/g of prostate tissue Interval 0.0 to 0.0

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Steven K. Clinton

The Ohio State University

Phone: 614-293-2886

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place