Tomato-based randomized controlled trial

[pjoshea13]

New Norwegian study below.

It's one of those small-populaton 3-week pre-surgery intervention studies that are useful for building hypotheses, but don't really prove much.

In this case, 79 participants split between two arms & controls:

"1) tomato products containing 30 mg lycopene per day"

"2) tomato products plus selenium, omega-3 fatty acids, soy isoflavones, grape/pomegranate juice, and green/black tea (tomato-plus)"

On the whole, the effect on PSA did not vary between the three groups.

However: in "intermediate risk (n = 41) patients ... median PSA decreased significantly in the tomato group as compared to controls (-2.9% and +6.5% respectively ...)"

"median PSA-values decreased by 1% in patients with the highest increases in plasma lycopene, selenium and C20:5 n-3 fatty acid, compared to an 8.5% increase in the patients with the lowest increase in lycopene, selenium and C20:5 n-3 fatty acid ..."

"Also, PSA decreased in patients with the highest increase in lycopene alone ..."

How many researchers are needed for a 3-week study of 79 men? In Oslo: 19!

-Patrick

ncbi.nlm.nih.gov/pubmed/274...

Clin Nutr. 2016 Jun 30. pii: S0261-5614(16)30147-9. doi: 10.1016/j.clnu.2016.06.014. [Epub ahead of print]

Tomato-based randomized controlled trial in prostate cancer patients: Effect on PSA.

Paur I1, Lilleby W2, Bøhn SK3, Hulander E4, Klein W5, Vlatkovic L6, Axcrona K7, Bolstad N8, Bjøro T9, Laake P10, Taskén KA11, Svindland A12, Eri LM13, Brennhovd B14, Carlsen MH15, Fosså SD16, Smeland SS17, Karlsen AS18, Blomhoff R19.

Author information

1Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, PO Box 1046, Blindern, 0316 Oslo, Norway. Electronic address: [e-mail].

2Division of Cancer Medicine, Transplantation and Surgery, Oslo University Hospital, PO Box 4950, Nydalen, 0424 Oslo, Norway. Electronic address: [e-mail].

3Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, PO Box 1046, Blindern, 0316 Oslo, Norway. Electronic address: [e-mail].

4Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, PO Box 1046, Blindern, 0316 Oslo, Norway. Electronic address: [e-mail].

5Division of Cancer Medicine, Transplantation and Surgery, Oslo University Hospital, PO Box 4950, Nydalen, 0424 Oslo, Norway. Electronic address: [e-mail].

6Division of Cancer Medicine, Transplantation and Surgery, Oslo University Hospital, PO Box 4950, Nydalen, 0424 Oslo, Norway. Electronic address: [e-mail].

7Division of Cancer Medicine, Transplantation and Surgery, Oslo University Hospital, PO Box 4950, Nydalen, 0424 Oslo, Norway; Department of Urology, Akershus University Hospital, 1748 Lørenskog, Norway. Electronic address: [e-mail].

8Department of Medical Biochemistry, Oslo University Hospital, PO Box 4950, Nydalen, 0424 Oslo, Norway. Electronic address: [e-mail].

9Department of Medical Biochemistry, Oslo University Hospital, PO Box 4950, Nydalen, 0424 Oslo, Norway; Institute of Clinical Medicine, University of Oslo, PO Box 1171, Blindern, 0318 Oslo, Norway. Electronic address: [e-mail].

10Department of Biostatistics, Institute of Basic Medical Sciences, University of Oslo, PO Box 1122, Blindern, 0317 Oslo, Norway. Electronic address: [e-mail].

11Division of Cancer Medicine, Transplantation and Surgery, Oslo University Hospital, PO Box 4950, Nydalen, 0424 Oslo, Norway; Institute of Clinical Medicine, University of Oslo, PO Box 1171, Blindern, 0318 Oslo, Norway. Electronic address: [e-mail].

12Division of Cancer Medicine, Transplantation and Surgery, Oslo University Hospital, PO Box 4950, Nydalen, 0424 Oslo, Norway. Electronic address: [e-mail].

13Division of Cancer Medicine, Transplantation and Surgery, Oslo University Hospital, PO Box 4950, Nydalen, 0424 Oslo, Norway. Electronic address: [e-mail].

14Division of Cancer Medicine, Transplantation and Surgery, Oslo University Hospital, PO Box 4950, Nydalen, 0424 Oslo, Norway. Electronic address: [e-mail].

15Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, PO Box 1046, Blindern, 0316 Oslo, Norway. Electronic address: [e-mail].

16Division of Cancer Medicine, Transplantation and Surgery, Oslo University Hospital, PO Box 4950, Nydalen, 0424 Oslo, Norway. Electronic address: [e-mail].

17Division of Cancer Medicine, Transplantation and Surgery, Oslo University Hospital, PO Box 4950, Nydalen, 0424 Oslo, Norway. Electronic address: [e-mail].

18Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, PO Box 1046, Blindern, 0316 Oslo, Norway. Electronic address: [e-mail].

19Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, PO Box 1046, Blindern, 0316 Oslo, Norway; Division of Cancer Medicine, Transplantation and Surgery, Oslo University Hospital, PO Box 4950, Nydalen, 0424 Oslo, Norway. Electronic address: [e-mail].

Abstract

BACKGROUND & AIMS:

The effect of lycopene-containing foods in prostate cancer development remains undetermined. We tested whether a lycopene-rich tomato intervention could reduce the levels of prostate specific antigen (PSA) in prostate cancer patients.

METHODS:

Prior to their curative treatment, 79 patients with prostate cancer were randomized to a nutritional intervention with either 1) tomato products containing 30 mg lycopene per day; 2) tomato products plus selenium, omega-3 fatty acids, soy isoflavones, grape/pomegranate juice, and green/black tea (tomato-plus); or 3) control diet for 3 weeks.

RESULTS:

The main analysis, which included patients in all risk categories, did not reveal differences in changes of PSA-values between the intervention and control groups. Post-hoc, exploratory analyses within intermediate risk (n = 41) patients based on tumor classification and Gleason score post-surgery, revealed that median PSA decreased significantly in the tomato group as compared to controls (-2.9% and +6.5% respectively, p = 0.016). In separate post-hoc analyses, we observed that median PSA-values decreased by 1% in patients with the highest increases in plasma lycopene, selenium and C20:5 n-3 fatty acid, compared to an 8.5% increase in the patients with the lowest increase in lycopene, selenium and C20:5 n-3 fatty acid (p = 0.003). Also, PSA decreased in patients with the highest increase in lycopene alone (p = 0.009).

CONCLUSIONS:

Three week nutritional interventions with tomato-products alone or in combination with selenium and n-3 fatty acids lower PSA in patients with non-metastatic prostate cancer. Our observation suggests that the effect may depend on both aggressiveness of the disease and the blood levels of lycopene, selenium and omega-3 fatty acids.

Copyright © 2016 The Author(s). Published by Elsevier Ltd.. All rights reserved.

KEYWORDS:

Diet; Lycopene; Prostate cancer; Prostate specific antigen; Selenium; Tomato

PMID: 27406859 DOI: 10.1016/j.clnu.2016.06.014

[PubMed - as supplied by publisher]

[AlanMeyer]

When I was diagnosed in 2003 lycopene was all the rage among patients looking for some way they can fight their cancer. I took lycopene pills myself and they were found in all the over the counter prostate pills.

Then they seem to have faded from view and nobody talked about lycopene anymore.

There sure seem to be a lot of fads in medical and nutrition treatment.

Alan

[adlerman in reply to AlanMeyer]

In the late 60's I went on the Atkins Diet- not to lose weight but to control panic attacks. Today the Atkins Diet is still around- 47 years later. It's not for everyone but if you're insulin resistant it seems to be helpful- at least it was for me.

[pjoshea13 in reply to AlanMeyer]

Alan,

Same for me in 2004. But I was very taken with the paper that started the fad in 1995.

"... food-frequency questionnaire mailed to participants in the Health Professionals Follow-up Study in 1986, we assessed dietary intake for a 1-year period for a cohort of 47,894 eligible subjects initially free of diagnosed cancer."

"Between 1986 and 1992, 812 new cases of prostate cancer, including 773 non-stage A1 cases, were documented."

Only four foods "were significantly associated with lower prostate cancer risk; of the four--tomato sauce .., tomatoes .., and pizza" "were primary sources of lycopene".

To have 3 foods out of only 4 having lycopene, & for those foods to be unrelated to a particularly "healthy" diet (i.e. confounding factors being unlikely) - I bought into it.

There are now 432 PubMed hits for <prostate lycopene> (a lot of them mouse studies), & along the way, things became less clearer.

Edward Giovannucci started the fad 21 years ago. He is co-author of 25 PCa-lycopene papers - the most recent in March. What I realized some years ago, is that EG probably loves the lack of closure. There have been U.S. & international lycopene conferences, & I bet he attended every one.

The old 3-week intervention study prior to surgery has been done before:

[2] (2001) "Plasma prostate-specific antigen levels decreased by 18% in the intervention group, whereas they increased by 14% in the control group".

But they also learned a few things from the prostates after surgery.

I remain a believer, but ...

-Patrick

[1] ncbi.nlm.nih.gov/pubmed/747...

[2] ncbi.nlm.nih.gov/pubmed/114...

[Hidden]

Thanks for posting this, important reading.