Findings from the eight week study also demonstrate a positive influence on total prostate-specific antigens (TPSA) and scores for benign prostatic hyperplasia (BPH) symptoms, body max index (BMI), and weight circumference (WC), the authors note.
Although the effects on IGF-1 levels was the only statistically significant result, compared to the placebo, the authors nonetheless maintain that combined intake strengthened lycopene efficacy and note that “lycopene and FruHis alone were clinically important”.
Indeed, lycopene induced a 13.2% reduction in TPSA, while FruHis supplementation had no effect. However, administration of both compounds reduced levels by 13 to 30.3% and the same pattern was observed for all other parameters assessed.
“It had been shown that FruHis exerts antioxidant and anti-cancer properties. Since both lycopene and FruHis have antioxidant and anticancer effects, FruHis intake may have a synergistic effect on the beneficial effects of lycopene,” they say.
Lycopene is found in tomatoes and helps prevent and manage BPH, mainly through antioxidant activity, inhibition of cell cycle progression, induction of apoptosis, increased gap-junctional cell communication, and inhibition of insulin-like growth factor I signal transduction, the authors explain.
“It is proposed that lycopene contributes to some physiological pathways through inhibition of cell cycle progression, interleukin-6 expression, and androgen activation and signalling. Hence, lycopene interferes with oestrogen and androgen signalling, which has been proven to influence the production of IGF-1 and TPSA.”
Antioxidant properties of lycopene may also offer protection by reducing oxidative stress that contribute to the disease pathophysiology, they add.
On the other hand, FruHis is a ketosamine released following heat-processing of tomatoes. It is composed of fructose and histidine that are indigestible but partially absorbed into the bloodstream and exert antioxidant and anti-cancer properties.
The two compounds may interact and offer higher prostrate cancer protection, but the mechanisms and degree of protection is unclear, the authors say.
Male patients (48) aged 55 to 75 years were recruited to the eight-week trial from outpatients with BPH at the Tehran University of Medical Sciences. BPH was diagnosed by a urologist based on patient history, digital rectal examination (DRE), and lab analyses.
Subjects were randomly assigned to either the lycopene with FruHis (11), lycopene (12), FruHis (12), or placebo (13) group. Those in the lycopene plus FruHis group administered one capsule containing 25mg/day of lycopene and another with 10mg/day of FruHis. The other intervention groups were given either lycopene or FruHis capsules along with a placebo capsule containing starch, and the placebo group administered two placebo capsules.
Biochemical assessments of venous blood samples were carried out to measure TPSA, free prostrate specific antigens (FPSA), and serum IGF-1 concentrations. Symptoms and QoL were assessed using the American Urological Association (AUA) symptom index and anthropometric measures (BMI and WC) based on US National Institutes of Health protocols.
FruHis supplementation increased the reducing effect of lycopene on IGF-1 by 11.3 to 18%. Observed increases were higher in the group receiving both compounds, as opposed to lycopene alone, the authors say.
“Overall, it seems that the combined intake of lycopene and FruHis, similar to the intake of tomato products containing both lycopene and FruHis, has a better reducing effect on IGF-1 compared to their intakes alone.”
Changes in WC were also statistically significant with supplementation of both compounds.
However, FruHis with lycopene induced a “non-significant decrease” in TPSA from 13.2 to 30.3%, which was also observed in previous studies on heat-processed tomato products with high levels of both compounds.
“This might be explained by the low sample size of the current pilot study. In addition, the low dosage of lycopene and FruHis might be another reason,” the authors assert.
Lycopene and FruHis improved QoL scores and, while not statistically significant, the size of changes was clinically notable. Lycopene with FruHis increased QoL by 18.2%, and lycopene or FruHis alone by 33.3%.
The authors comment: “In agreement with our findings, Cormio et al. reported that consumption of whole tomato food supplement (WTFS), which may contain both lycopene and FruHis, decreases the symptom score from 9.05 to 7.15 and improves QoL, about one score, in patients with BPH.”
They speculate that non-significant findings may be due to subject baseline characteristics, as well as the small sample size and short duration of studies. For example, subjects taking lycopene were often smokers and suffered from hypertension, compared to the group administering both, and could explain the lower reduction of IGF-1 in the lycopene group.
“Cigarette smoking can increase oxidative stress and inflammation and attenuate the beneficial effects of lycopene. In addition, a significant association between hypertension and IGF-1 levels was reported in previous studies.”
Furthermore, there was a higher prevalence for diabetes among patients in the lycopene plus FruHis group, compared to other intervention groups, which may have attenuated the reducing effects on TPSA levels and may explain non-significance, compared to the placebo.
The study authors conclude that additional studies are required to confirm findings and examine the effects of other tomato constituents on BPH outcomes.
Source: Frontiers in Nutrition
Published online, November 3, 2022: http://doi.org/10.3389/fnut.2022.2022836
‘FruHis significantly increases the anti-benign prostatic hyperplasia effect of lycopene: A double-blinded randomized controlled clinical trial’
Author: Alireza Sadeghi, Ahmad Saedisomeolia, Leili Jalili-Baleh, Mehdi Khoobi, Mohammad Soleimani, Ali Mohammad Fakhr Yasseri, Mir Saeed Yekaninejad, Amirreza Farzin, Erfan Amini and Mohammad Reza Nowroozi