Efficacy of a Proprietary Trigonella foenum‐graecum L. De‐Husked Seed Extract in Reducing Menopausal Symptoms in Otherwise Healthy Women: A Double‐Blind,Randomized, Placebo‐Controlled Study

Trigonella foenum‐graecum seed extract has demonstrated hormone modulatory activity, providing biological plausibility for relieving menopausal symptoms. The study aimed to assess efficacy of a standardized T. foenum‐graecum de‐husked seed extract in reducing menopausal symptoms in healthy aging women. The study was a double‐blind, randomized, placebo‐controlled trial that recruited 115 women aged 40 to 65 years of which 59 were allocated to active (n = 54 completed) and 56 to placebo (n = 50 completed). Active treatment was T. foenum‐graecum de‐husked seed extract, 600 mg per day for 12 weeks. Outcome measures included Menopause‐Specific Quality of Life (MENQOL) questionnaire, frequency of hot flushes and night sweats and serum estradiol levels. There was a significant reduction in menopausal symptoms in the active group compared with placebo as assessed by total MENQOL score (p < 0.001); reflected by significant improvements in the vasomotor (p < 0.001), psychosocial (p < 0.001), physical (p < 0.001) and sexual symptoms (p < 0.001) domains. Vasomotor outcomes correlated with hot flushes, the active group reporting significantly less daytime hot flushes and night sweats at 12 weeks (p < 0.001). The average estradiol levels were similar in both the active group and placebo group after treatment. This study demonstrated that this proprietary T. foenum‐graecum de‐husked seed extract may reduce menopausal symptoms in healthy women. Copyright © 2017 John Wiley & Sons, Ltd.     

Physiological Aspects of Male Libido Enhanced by Standardized Trigonella foenum‐graecum Extract and Mineral Formulation

The aim of the clinical study was to evaluate the effect of Testofen, a standardized Trigonella foenum‐graecum (Fenugreek) extract and mineral formulation, on male libido (sexual drive, urge or desire) in a double blind randomized placebo controlled study. The study recruited 60 healthy males aged between 25 and 52, without erectile dysfunction and randomized to an oral dose (two tablets per day) of the active treatment (600 mg Testofen per day) or placebo for 6 weeks. The primary outcome measure was the DISF‐SR (male) self‐administered QOL total score and the four domain scores. The secondary outcome was specific quality of life parameters. Testofen had an overall positive effect on physiological aspects of libido. In particular, there was a significant increase in the subdomains of sexual arousal and orgasm. Testofen had a positive effect on QOL in self‐reported satisfaction with muscle strength, energy and well‐being but did not have an effect on mood or sleep. Serum prolactin and testosterone levels remained within the reference range. It was concluded that Testofen demonstrated a significant positive effect on physiological aspects of libido and may assist to maintain normal healthy testosterone levels. Copyright © 2011 John Wiley & Sons, Ltd.     

A Novel Extract of Fenugreek Husk (FenuSMART™) Alleviates Postmenopausal Symptoms and Helps to Establish the Hormonal Balance: A Randomized,Double‐Blind,Placebo‐Controlled Study

Despite the widespread use of hormone replacement therapy, various reports on its side effects have generated an increasing interest in the development of safe natural agents for the management of postmenopausal discomforts. The present randomized, double‐blinded, placebo‐controlled study investigated the effect of 90‐day supplementation of a standardized extract of fenugreek (Trigonella foenum‐graecum) (FenuSMART?), at a dose of 1000 mg/day, on plasma estrogens and postmenopausal discomforts. Eighty‐eight women having moderate to severe postmenopausal discomforts and poor quality of life (as evidenced from the scores of Greene Climacteric Scale, short form SF‐36® and structured medical interview) were randomized either to extract‐treated (n = 44) or placebo (n = 44) groups. There was a significant (p < 0.01) increase in plasma estradiol (120%) and improvements on various postmenopausal discomforts and quality of life of the participants in the extract‐treated group, as compared with the baseline and placebo. While 32% of the subjects in the extract group reported no hot flashes after supplementation, the others had a reduction to one to two times per day from the baseline stages of three to five times a day. Further analysis of haematological and biochemical parameters revealed the safety of the extract and its plausible role in the management of lipid profile among menopausal women. Copyright © 2016 John Wiley & Sons, Ltd.     

The effect of Trigonella foenum‐graecum extract on prostate‐specific antigen,and prostate function in otherwise healthy men with benign prostate hyperplasia

The aim of this trial was to evaluate the effect of a standardised Trigonella foenum‐graecum (Fenugreek) extract on the symptoms of benign prostate hyperplasia (BPH) using a double‐blind randomised placebo controlled design. The study recruited 100 healthy males aged between 45 and 80 years with symptoms of BPH who recorded a minimum score of eight on the International Prostate Symptom Score. Participants were randomised to an oral dose of either 600mg Trigonella foenum‐graceum per day or placebo for 12 weeks. The primary outcome measure was the International Prostate Symptom Score total and subdomain scores. The secondary outcomes were serum levels of the hormones (testosterone, free testosterone, and sex hormone binding globulin) prostate‐specific antigen, and safety markers. The results indicated that Trigonella foenum‐graceum did not have an effect on improving the symptoms of BPH. Hormone levels, safety markers, and prostate‐specific antigen remained unchanged and within normal limits after 12 weeks, which adds to the safety profile of this specialised extract.     

Efficacy and Safety of Standardized Extract of Trigonella foenum‐graecum L Seeds as an Adjuvant to L‐Dopa in the Management of Patients with Parkinson's Disease

The objective of this study is to evaluate disease modifying efficacy and safety of a standardized extract of Trigonella foenum‐graecum L, Fenugreek (IBHB) (family Fabaceae) as a nutritional adjuvant to Levo‐dopa (L‐Dopa) in Parkinson's disease (PD) patients. We conducted double‐blind placebo‐controlled proof of concept clinical study of IBHB capsules (300 mg, twice daily) with matching placebo for 6 months of period in 50 patients of PD stabilized on L‐Dopa therapy. The efficacy outcome measures were the scores of Unified Parkinson's Disease Rating Scale (UPDRS ‐ total and its subsections), and Hoehn and Yahr (H&Y) staging at baseline and end of 6‐months treatment duration. Safety evaluation included haematology, biochemistry, urinalysis parameters and adverse event monitoring. Total UPDRS scores in IBHB treatment (0.098%) showed slower rise as opposed to steep rise (13.36%) shown by placebo. Further, Clinically Important Difference for total UPDRS scores and scores of motor subsection of UPDRS was found to be 5.3 and 4.8, respectively, in favour of IBHB treatment. Similar improvement was shown by IBHB in terms of H&Y staging as compared with placebo. IBHB was found to have excellent safety and tolerability profile. In conclusion, IBHB can be useful adjuvant treatment with L‐Dopa in management of PD patients. Copyright © 2013 John Wiley & Sons, Ltd.     

Effect of furostanol glycosides from Trigonella foenum-graecum on the reproductive system of male albino rats

Trigonella foenum (TF) has long been used in the traditional Indian systems of medicine for the treatment of various ailments. The objective was to study the anabolic and androgenic activity of the furostanol glycosides fraction of Trigonella foenum‐graecum (Fenu‐FG) in immature castrated male Wistar rats. It was also aimed to investigate the effect of Fenu‐FG on testicular histology in non‐castrated immature rats. The animals (55 ± 5 g) were castrated. The rats were treated with either vehicle, testosterone (10 mg/kg s.c. bi‐weekly) or Fenu‐FG (10 and 35 mg/kg p.o.) once daily for 4 weeks. At the end of the study, blood was withdrawn, serum testosterone and BUN were measured. Animals were killed and reproductive organs were excised and weighed. Fenu‐FG (35 mg/kg p.o.) and testosterone (10 mg/kg, s.c. biweekly) increased the weight of the levator ani muscle as well as body weight. Fenu‐FG (10 or 35 mg/kg p.o.) did not change the testosterone level in castrated rats. Histopathological examination of the testis of non‐castrated rats treated with Fenu‐FG (10, 35 mg/kg p.o.) showed normal architecture of the testis. Fenu‐FG (35 mg/kg p.o.) showed anabolic activity without androgenic activity. Copyright © 2010 John Wiley & Sons, Ltd.     

Effect of date palm pollen supplementation on female sexual function in non-menopausal women: A double blind randomized clinical trial

Objective: Despite numerous experimental studies in the literature, there are few clinical trials regarding the effect of date palm pollen (DPP) supplementation on sexual function improvement. In the present study, we sought to evaluate the impact of DPP on female sexual function in Iranian non-menopausal women. Methods: Between October 2019 and December 2019, health centers in the city of Khalkhal, volunteers meeting the inclusion criteria were recruited in randomized clinical trials. Sixty-eight women were randomly stratified and assigned to one of the two study groups: placebo group (n = 35) and palm pollen group (n = 35), and received a starch or palm pollen capsule (300 mg per day), respectively, for 35 d. The Female Sexual Function Index (FSFI) instrument was used to assess female sexual function. Results: After DPP supplementation, the increase in desire, lubrication, and the overall score, was statistically significant compared to the placebo group (P = 0.002, P = 0.000, and P = 0.042; respectively); Whilst there was no significant differences in the remaining domains (arousal: P = 0.763; orgasm: P = 0.370; satisfaction: P =0.474; pain: P = 0.259). There was a statistically significant positive correlation between the coitus and preintervention levels of desire (r = 0.298, P = 0.038), arousal (r = 0.328, P = 0.021), lubrication (r = 0.361, P = 0.011), orgasm (r = 0.320, P = 0.025), satisfaction (r = 0.327, P = 0.022), and overall scores (r = 0.338, P = 0.018). Conclusion: This study suggests that DPP (300 mg supplementation for 35 d), given to non-menopausal women, could improve the lubrication and desire domains of FSFI.     

Kava for the Treatment of Generalized Anxiety Disorder RCT: Analysis of Adverse Reactions,Liver Function,Addiction, and Sexual Effects

Presently, little is known about a number issues concerning kava (Piper methysticum), including (i) whether kava has any withdrawal or addictive effects; (ii) if genetic polymorphisms of the cytochrome (CYP) P450 2D6 liver enzyme moderates any potential adverse effects; and (iii) if medicinal application of kava has any negative or beneficial effect on sexual function and experience. The study design was a 6‐week, double‐blind, randomized controlled trial (n = 75) involving chronic administration of kava (one tablet of kava twice per day; 120 mg of kavalactones per day, titrated in non‐response to two tablets of kava twice per day; 240 mg of kavalactones) or placebo for participants with generalized anxiety disorder. Results showed no significant differences across groups for liver function tests, nor were there any significant adverse reactions that could be attributed to kava. No differences in withdrawal or addiction were found between groups. Interesting, kava significantly increased female's sexual drive compared to placebo (p = 0.040) on a sub‐domain of the Arizona Sexual Experience Scale (ASEX), with no negative effects seen in males. Further, it was found that there was a highly significant correlation between ASEX reduction (improved sexual function and performance) and anxiety reduction in the whole sample. Copyright © 2013 John Wiley & Sons, Ltd.     

Androgenic and Spermatogenic Activity of Alkylamide‐Rich Ethanol Solution Extract of Anacyclus pyrethrum DC

Anacyclus pyrethrum (A. pyrethrum) has been used as Vajikaran Rasayana (aphrodisiac) in traditional Indian ayurvedic medicine to treat male sexual dysfunction, including infertility. Aphrodisiac activity may be due to an increase in the production or effect of androgens, so this study sought to evaluate the androgenic and spermatogenic potential of the alkylamide‐rich ethanol solution extract. Male Wistar strain rats weighing between 150 and 180 g were completely randomized divided into five groups. The ethanol solution extract of A. pyrethrum was administered to groups of rats in 50, 100, and 150 mg/kg doses for a period of 28 days, and the action was compared with control and testosterone‐treated rats. Thirteen N‐alkylamides were detected in the extract by using HPLC/UV/electrospray ionization mass spectrometry method. Extract administration at all the doses produced significant increase in body weight, sperm count, motility, and viability along with serum testosterone, luteinizing hormone, and follicle‐stimulating hormone concentrations. Histoarchitecture of testis revealed increased spermatogenic activities. Seminal fructose content was also significantly increased after 28 days of treatment. Our results suggest that the ethanol solution extract of the roots of A. pyrethrum has androgenic potential and may improve male fertility by enhancing spermatogenesis. Copyright © 2012 John Wiley & Sons, Ltd.     

Tongkat Ali as a Potential Herbal Supplement for Physically Active Male and Female Seniors—A Pilot Study

Tongkat Ali (Eurycoma longifolia; TA) is known to increase testosterone levels and alleviate aging males' symptoms. This study aimed at investigating TA as an ergogenic supplement for elderly people. Thirteen physically active male and 12 physically active female seniors (57–72 years) were supplemented with 400‐mg TA extract daily for 5 weeks. Standard hematological parameters were taken. In addition, the concentrations of total and free testosterone, dihydroepiandrosterone, cortisol, insulin‐like growth factor‐1, and sex hormone‐binding globulin were analyzed. As additional biochemical parameters, blood urea nitrogen and creatine kinase as parameters of kidney function and muscle damage, respectively, as well as the muscle strength by a simple handgrip test were determined. After treatment, hemoglobin, testosterone, and dihydroepiandrosterone concentrations, and the ratio of total testosterone/cortisol and muscle force remained significantly lower in female seniors than in male seniors. Hematocrit and erythrocyte count in male seniors increased slightly but were significantly higher than in female seniors. Treatment resulted in significant increases in total and free testosterone concentrations and muscular force in men and women. The increase in free testosterone in women is thought to be due to the significant decline in sex hormone‐binding globulin concentrations. The study affirms the ergogenic benefit of TA through enhanced muscle strength. Copyright © 2013 John Wiley & Sons, Ltd.     

A pilot investigation into the effect of maca supplementation on physical activity and sexual desire in sportsmen

Aims of the study

Maca (Lepidium meyenii Walp) is consumed both as a sports supplement by strength and endurance athletes, and as a natural stimulant to enhance sexual drive. However, whether or not the postulated benefits of maca consumption are of scientific merit is not yet known. The aim of the study was therefore to investigate the effect of 14 days maca supplementation on endurance performance and sexual desire in trained male cyclists.

Materials and methods

Eight participants each completed a 40 km cycling time trial before and after 14 days supplementation with both maca extract (ME) and placebo, in a randomised cross-over design. Subjects also completed a sexual desire inventory during each visit.

Results

ME administration significantly improved 40 km cycling time performance compared to the baseline test (P = 0.01), but not compared to the placebo trial after supplementation (P > 0.05). ME administration significantly improved the self-rated sexual desire score compared to the baseline test (P = 0.01), and compared to the placebo trial after supplementation (P = 0.03).

Conclusions

14 days ME supplementation improved 40 km cycling time trial performance and sexual desire in trained male cyclists. These promising results encourage long-term clinical studies involving more volunteers, to further evaluate the efficacy of ME in athletes and normal individuals and also to explore its possible mechanisms of action.     

Evaluation of the aphrodisiac activity of Litsea chinensis (Lauraceae) and Orchis malculata (Orchidaceae) extracts in rats

The ethanolic extract of the bark of Litsea chinensis and the tuber of Orchis maculata were studied on male sexual behaviour in rats using a battery of tests including penile erection, homosexual mounting, stretching/yawning, aggressive behaviour, copulatory behaviour and orientational activities. The extract of O. maculata (500 mg/kg, p.o.) produced a significant increase in penile erection index, homosexual mounting and facilitated sexual behaviour and orientational activity, as evidenced by increased mounting performance, anogenital sniffing, intromission and ejaculation frequencies. The group of animals given the extract of L. chinensis produced a significant increase in ejaculation latency with a significant decrease in ejaculation frequency. The results indicate that O. maculata extract enhanced sexual arousal in male rats.     

Hypolipidaemic effect of fenugreek seeds. A clinical study

The hypolipidaemic effect of fenugreek seeds (Trigonella foenum graecum L.) was evaluated in ten hyperlipidaemic subjects. Isocaloric diets with and without fenugreek were each given for 20 days. Ingestion of experimental diets, containing 100 g of debitterized fenugreek powder, resulted in a significant reduction in the serum total cholesterol, LDL and VLDL cholesterol and triglyceride levels. HDL cholesterol levels were not altered but the ratio with total cholesterol and LDL and VLDL cholesterol were significantly increased. These results indicate the beneficial effect of fenugreek seeds in hyperlipidaemic patients.     

Effects of Lepidium sativum,Nigella sativa and Trigonella foenum‐graceum on Phenytoin Pharmacokinetics in Beagle Dogs

The present work was designed to evaluate the effect of some commonly used herbs viz. garden cress (Lepidium sativum), black seed (Nigella sativa) and fenugreek (Trigonella foenum‐graceum) on the disposition of phenytoin after oral administration in a dog model. Phenytoin was given orally at a dose of 50 mg, and blood samples were obtained for the determination of drug's pharmacokinetic parameters. After a suitable washout period, animals were commenced on a specific herb treatment for one week. Garden cress treatment caused a modest increase in maximum observed concentration (C_max) and terminal half‐life (T_1/2λ) of phenytoin with a reduction in clearance by 33%. The effect of black seed therapy was more drastic on drug elimination and to a lesser extent on its volume of distribution at steady state (V_ss) with a consequent reduction in systemic exposure measured by area under the curve (AUC_0‐∞) by about 87%. The effect of fenugreek therapy resembled, albeit to a lesser extent, that of black seed with a significant reduction in AUC_0‐∞ by ~72%. In addition, there was a 73% increase in V_ss. Our findings suggest that the phenytoin disposition can be significantly altered by the concurrent consumption of tested herbal products. Copyright © 2013 John Wiley & Sons, Ltd.     

Effects of nutraceuticals on sexual satisfaction and lower urinary tract symptoms in a cohort of young–old men

The aim of this study was to evaluate the effects of nutraceuticals containing multiple supplemental facts (Virherbe®/Rekupros®) on sexual satisfaction and lower urinary tract symptoms (LUTS) in young–old men. In an open‐label trial, 40 males (mean age 66 ± 13) with sexual disturbances and mild LUTS but without cognitive/motor impairment and clinical hypogonadism were enrolled. Sexual desire (SD; IIEF‐SD domain) and satisfaction (Global Assessment Question; GAQ), the capacity to perform daily activities (evaluated by 6‐min walking test [6MWT]), and International Prostate Symptoms Scores (IPSS) were evaluated before and after oral administration of 2 capsules/day of each supplement for 8 weeks. The difference from baseline for SD was +2.6 (p < .05) and ?4.2 points for IPSS (p < .05), with significance in subscales of urinary streaming/nocturia (p < .01), respectively; 6MWT increased from 507 ± 44 versus 527 ± 58 meters (p < .001). GAQ scale‐responses showed overall improvement in overall 75% population, with a significant improvement in QoL (p < .01). These changes returned to baseline at 1‐month withdrawal follow‐up. No adverse events were reported. These supplemental facts improved sexual desire, satisfaction with sex life, physical performance, and LUTS in young–old men, suggesting that they may be effective in patients in whom standard treatments are not suitable.     

Combination of Comfrey Root Extract Plus Methyl Nicotinate in Patients with Conditions of Acute Upper or Low Back Pain: A Multicentre Randomised Controlled Trial

This randomised, multicentre, double‐blind, three‐arm, placebo‐controlled trial compared a topical combination of 35% comfrey root extract plus 1.2% methyl nicotinate versus a single preparation of methyl nicotinate or placebo cream for relief of acute upper or low back pain. 379 patients were randomly assigned to three groups (combination, n = 163; methyl nicotinate, n = 164; placebo, n = 52). They applied a 12 cm layer of cream three times daily for 5 days. The primary efficacy variable was the area under the curve (AUC) of the visual analogue scale (VAS) on active standardised movement values at visits 1 to 4. Secondary measures included back pain at rest, pressure algometry, consumption of analgesic medication, functional impairment measured with Oswestry Disability Index, and global assessment of response. The AUC of the VAS on active standardised movement was markedly smaller in the combination treatment group than in the methyl nicotinate and in the placebo group (ANOVA: p < 0.0001). The combination demonstrated superiority to the two other treatment arms, while methyl nicotinate displayed a considerable effect as well. Copyright © 2012 John Wiley & Sons, Ltd.     

Effect of fenugreek seeds on blood lipid peroxidation and antioxidants in diabetic rats

The effect of fenugreek seeds (Trigonella foenum graecum) on blood lipid peroxidation and antioxidant status in alloxan diabetic rats was studied. Increased lipid peroxidation and alterations in circulating antioxidants were observed in the diabetic state. The levels of glutathione, ascorbic acid and β‐carotene in blood were significantly lowered and α‐tocopherol content was increased. Supplementation of fenugreek seeds in the diet lowered lipid peroxidation. The contents of glutathione and β‐carotene were increased and the α‐tocopherol content was lowered. The level of ascorbic acid was unaltered. The level of antioxidants were higher in normal rats which were fed with the fenugreek supplemented diet compared with control animals which were fed commercial rat chow. The study shows that disrupted free radical metabolism in diabetic animals may be normalized by fenugreek seed supplementation in the diet.­Copyright © 1999 John Wiley & Sons, Ltd.     

Immunomodulation in Middle‐Aged Humans Via the Ingestion of Physta® Standardized Root Water Extract of Eurycoma longifolia Jack—A Randomized,Double‐Blind,Placebo‐Controlled,Parallel Study

This study was aimed to investigate the capacity of a standardized root water extract of Eurycoma longifolia (Tongkat Ali, TA), Physta® to modulate human immunity in a middle‐aged Japanese population. This randomized, double‐blind, placebo‐controlled, parallel study was conducted for 4 weeks. Eighty‐four of 126 subjects had relatively lower scores according to Scoring of Immunological Vigor (SIV) screening. Subjects were instructed to ingest either 200 mg/day of TA or rice powder as a placebo for 4 weeks [TA and Placebo (P) groups] and to visit a clinic in Tokyo twice (weeks 0 and 4). SIV, immunological grade, immunological age, and other immune parameters were measured. Eighty‐three subjects completed the study; 40 in the TA group and 41 in the P group were statistically analyzed, whereas two were excluded from the analyses. At week 4, the SIV and immunological grade were significantly higher in the TA group than those in P group (p < 0.05). The numbers of total, naïve, and CD4⁺ T cells were also higher in the TA group than those in P group (p < 0.05). No severe adverse events were observed. The results suggest that ingestion of the root water extract of TA (Physta®) enhances comprehensive immunity in both middle‐aged men and women. This study is registered in UMIN‐CTR (UMIN000011753). Copyright © 2016 John Wiley & Sons, Ltd.     

Beneficial effects of nano‐curcumin supplement on depression and anxiety in diabetic patients with peripheral neuropathy: A randomized,double‐blind,placebo‐controlled clinical trial

Depression in patients with diabetes is associated with poor glycemic control and linked to an increased risk for diabetes complications such as neuropathy. Curcumin has shown potential antidepressant‐like activities in some studies. The present study is the first randomized controlled trial to test the efficacy of nano‐curcumin supplementation on depression, anxiety, and stress in patients with diabetic polyneuropathy. Eighty patients with diabetes were enrolled in this parallel, double‐blind, randomized, placebo‐controlled clinical trial. The participants were allocated randomly to the intervention (n = 40) and control (n = 40) groups. They received 80 mg of nano‐curcumin or placebo capsules daily for 8 weeks. At baseline and end of study, anthropometric measurements, dietary intake, physical activity, glycemic indices, and severity of neuropathy were assessed. The depression, anxiety, and stress level were measured by Depression, Anxiety, Stress Scale (DASS‐21‐items) questionnaire before and after the intervention. After intervention, there was a significant reduction in the mean score of depression in the nano‐curcumin group (from 16.7 [3.1] to 15.3 [2.6]) compared with placebo group (17.5 [3.2] to 17.3 [3.1]; p = .02). In addition, a significant fall was found in the mean score of anxiety in the nano‐curcumin group (from 22.4 [4.03] to 20.6 [3.4]) compared with the placebo group (21.9 [3.5] to 21.2 [3.5]; p = .009). Changes in stress score were not statistically significant between the two groups. These findings suggested that nano‐curcumin supplementation for 8 weeks was effective in reducing depression and anxiety scores in patients with diabetic polyneuropathy.     

Preliminary Safety Evaluation and Biochemical Efficacy of a Carum carvi Extract: Results from a Randomized,Triple‐Blind,and Placebo‐Controlled Clinical Trial

Carum carvi L. (Apiaceae) is known as caraway, and its derivatives find wide medicinal use for health purposes, including for gastrointestinal problems and obesity. Since there is inconsistency among the reports on the safety of this plant in humans, this research was aimed at assessing the safety of a characterized caraway aqueous extract (CAE) in a randomized, triple‐blind, placebo‐controlled study. Seventy, overweight and obese, healthy women were randomly assigned into placebo (n = 35) and plant extract (n = 35) groups. Participants received either 30 ml/day of CAE or placebo. Subjects were examined at baseline and after 12 weeks for changes in heart rate, blood pressure, urine test, 25‐item blood chemistries, and general health status. No significant changes of blood pressure, heart rate, urine specific gravity, and serum blood tests were observed between the two groups before and after treatment. However, in the complete blood count test, red blood cell levels were significantly (p < 0.01) increased, and platelet distribution width was significantly decreased after the dietary CAE treatment, as compared with placebo. No negative changes were observed in the general health status of the two groups. This preliminary study suggests that the oral intake of CAE appears to be without any adverse effects at a dosage of 30 ml daily for a period of 12 weeks. Copyright © 2014 John Wiley & Sons, Ltd.