Beneficial effects of fenugreek glycoside supplementation in male subjects during resistance training: A randomized controlled pilot study

AbstractPurposeTo evaluate the efficacy and safety of the glycoside fraction of fenugreek (Trigonella foenum-graecum) seeds (Fenu-FG) on physiological parameters related to muscle anabolism, androgenic hormones, and body fat in healthy male subjects during an 8-week resistance training program using a prospective, randomized, double-blind, placebo controlled design.MethodsSixty healthy male subjects were randomized to ingest capsules of Fenu-FG (1 capsule of 300 mg, twice per day) or the matching placebo at a 1:1 ratio. The subjects participated in a supervised 4-day per week resistance-training program for 8 weeks. The outcome measurements were recorded at recruitment (baseline) and at the end of the treatment (8 weeks). The efficacy outcome included serum testosterone (total and free) levels, muscle strength and repetitions to failure, metabolic markers for anabolic activity (serum creatinine and blood urea nitrogen), and % body fat. The standard safety measurements such as adverse events monitoring, vital signs, hematology, biochemistry, and urinalysis were performed.ResultsFenu-FG supplementation demonstrated significant anabolic and androgenic activity as compared with the placebo. Fenu-FG treated subjects showed significant improvements in body fat without a reduction in muscle strength or repetitions to failure. The Fenu-FG supplementation was found to be safe and well-tolerated.ConclusionFenu-FG supplementation showed beneficial effects in male subjects during resistance training without any clinical side effects

Preclinical safety evaluation of low molecular weight galactomannans based standardized fenugreek seeds extract

The objective of the present study was to evaluate acute oral toxicity, subchronic toxicity, and mutagenic potential of low molecular weight galactomannans based standardized fenugreek seeds extract (LMWGAL-TF) in laboratory animals rats as per Organization for Economic Co-operation and Development (OECD) guidelines. For the acute toxicity (AOT) study, LMWGAL-TF was orally administered to Sprague-Dawley (SD) rats at a dose of 2000 mg/kg with vehicle control (VC) group (n = 5 per sex per group) as per OECD guideline no. 423. For the repeated dose toxicity study, the SD rats were orally administered with a daily oral dose of LMWGAL-TF 250, 500 and 1000 mg/kg/day with VC group (n = 15 per sex) for a period of 90 days followed by a recovery period of 28 days as per OECD guideline no. 408. The effects on body weight, food and water consumption, organ weights with hematology, clinical biochemistry, and histology were studied. The mutagenic potential of LMWGAL-TF was tested using reverse mutation assay (AMES test, OECD guideline No. 471). The LMWGAL-TF did not show mortality or treatment-related adverse signs during acute (dose 2000 mg/kg) and subchronic (90-days repeated dose 250, 500 and 1000 mg/kg) administration. The LMWGAL-TF showed oral lethal dose (LD50) more than 2000 mg/kg during AOT study. The dose of 1000 mg/kg was found as no observed adverse effect level (NOAEL) in rats during subchronic toxicity study. Furthermore, LMWGAL-TF did not show mutagenic potential in vitro. In conclusion, LMWGAL-TF was found safe during acute and subchronic (90 days repeated dose) toxicity studies in rats with no mutagenicity

Effect of cyclodextrin garcinol complex on isoproterenol-induced cardiotoxicity and cardiac hypertrophy in rats

Background: Garcinol is a polyisoprenylated benzophenone derivative present in the fruit rinds of Garcinia species namely Garcinia indica (common name 'Kokum') and Garcinia cambogia (common name 'Gombogee'). It appears to be involved in the regulation of oxidative stress and antioxidant capacity of heart tissue when the heart is subjected to oxidative stress in various pathogenic conditions/ chemical agent. But garcinol is associated with severe limitation of instability and poor bioavailability which can be improved complexing cyclodextrin with garcinol (garcinol complex). Objective: The objective of the present study was to investigate effect of cyclodextrin with garcinol complex (20 mg/kg), on Iso induced cardiotoxicity and cardiac hypertrophy in rats.Methods: Male Wistar rats (250-300g) were divided into following 4 groups of six animals each. Group 1 was control (distilled water 2 ml/kg/day orally for 18 days and water for injection by i.p. from day 9 to day 18), group 2 was cyclodextrin (cyclodextrin 2 ml/kg/day orally for 18 days and water for injection by i.p. from day 9 to day 18), group 3 Iso (distilled water 2 ml/kg/day orally for 18 days and isoproterenol 1 mg/kg by i.p. from day 9 to day 18), group 4 garcinol complex (20 mg/kg/day orally for 18 days and isoproterenol 1 mg/kg by i.p. from day 9 to day 18). After 24 hrs of last dose of isoproterenol, electrocardiogram (ECG) and heart rate were recorded in anaesthetized rats. The animals were sacrificed by overdose of ether. The hearts of animals were isolated for measurement of reduced glutathione (GSH) and lipid peroxidation (MDA). Results: Isoproterenol treated rats showed significant myocardial hypertrophy, decreased endogenous antioxidants when compared with the control group animals. The garcinol complex (20 mg/kg) treatment for 18 days showed significant cardioprotective activity by lowering the myocardial hypertrophy, level of lipid peroxidation (MDA content) as well as elevated the level of GSH. The results suggest pre-treatment of garcinol complex (20 mg/kg), may offer potential benefits in the management of cardiotoxicity and cardiac hypertrophy. Conclusion: It is thus concluded that Garcinol Complex (20 mg/kg) administration offered significant protection against isoproterenol induced cardiotoxicity and cardiac hypertrophy as well as decreased myocardial injury by preservation of endogenous antioxidants and reduction of lipid peroxidation in rat heart

PRENATAL DEVELOPMENTAL TOXICITY EVALUATION OF LOW MOLECULAR WEIGHT GALACTOMANNANS BASED STANDARDIZED FENUGREEK SEED EXTRACT DURING ORGANOGENESIS PERIOD OF PREGNANCY IN RATS

Objective: To evaluate the prenatal developmental toxicity of low molecular weight galactomannans based standardized fenugreek seed extract (LMWGAL-TF).Methods: Rats received oral administration of LMWGAL-TF (250, 500 and 1000 mg/kg) during the period of gestation from day 5 (implantation day)–19 (1 d before expected day of parturition) post conception. Maternal, embryo, and fetal toxicity parameters were evaluated.Results: LMWGAL-TF exposure did not produce maternal (clinical observations, body weight gain, food intake) and embryo–fetal toxicity. Occasional skeletal and visceral malformations, unrelated to the treatments, were seen in both LMWGAL-TF-treated and vehicle control (VC) groups.Conclusion: Oral exposure of LMWGAL-TF during the prenatal period did not induce significant maternal and embryo–fetal toxicity up to a dose of 1000 mg/kg in rats. The dose of 1000 mg/kg was considered as NOAEL for LMWGAL-TF.Keywords: Developmental toxicity, Low molecular weight galactomannans, Standardized fenugreek seed extract, OECD Test No. 414, Reproductive system, Rat

EFFECTS OF A PROPRIETARY BLEND RICH IN GLYCOSIDE BASED STANDARDIZED FENUGREEK SEED EXTRACT (IBPR) ON INFLAMMATORY MARKERS DURING ACUTE ECCENTRIC RESISTANCE EXERCISE IN YOUNG SUBJECTS

  Objective: To assess the efficacy of a proprietary blend rich in glycoside based standardized fenugreek seed extract (400 mg) and minor quantities of curcumin and cinnamon (25 mg each) supplementation (IBPR) on inflammatory markers related to skeletal muscle soreness using double-blind placebo control, parallel design.Methods: A total of 20 healthy non-resistance trained young male and female subjects were assigned to ingest either IBPR or matching placebo for 14 days before the eccentric exercise bout. Subjects were instructed to perform 24 sets with 10 eccentric knee extensor repetitions (with one leg at 30°/s on an isokinetic device). Subjects had their blood drawn at baseline, immediately post, 1 hr, 3 hrs, and 24 hrs post-eccentric exercise. Efficacy in terms of serum levels of anti-inflammatory cytokines interleukin-10 (IL-10), pro-inflammatory cytokines (IL-1ra, IL-1b, IL-6, and tumor necrosis factor) and safety in terms of kidney function (blood urea nitrogen (BUN), serum creatinine, BUN to creatinine ratio), and differential leukocyte count were measured. The data of each parameter were analyzed by two-way repeated measure ANOVA.Results: Significant time-dependent effects were observed in IL1b, IL6, and creatinine values from baseline whereas significant treatment dependent effect was seen in IL-1ra. IBPR was found to be safe and well tolerated.Conclusion: IBPR supplementation showed a significant anti-inflammatory efficacy on eccentric exercise-induced inflammatory markers of skeletal muscle soreness in non-resistance trained subjects

EFFECTS OF GLYCOSIDES BASED FENUGREEK SEED EXTRACT ON SERUM TESTOSTERONE LEVELS OF HEALTHY SEDENTARY MALE SUBJECTS: A EXPLORATORY DOUBLE BLIND, PLACEBO CONTROLLED, CROSSOVER STUDY

Objective: To evaluate acute effects of IND9 supplementation on serum testosterone levels in healthy sedentary male subjects. Methods: The study was designed as randomized, double blind, placebo controlled, two period, crossover study with 7 days of washout period using single study center. Sixteen healthy male subjects were randomized and received single dose of 600 mg (two capsules of 300 mg) of either IND9 or matching placebo capsules during each of the 2 study periods of 10 h each. Blood samples were collected three times at 3 h, 7 h and 10 h. The outcome measures were measurement of serum free testosterone (mFT) and total testosterone (TT), calculated levels of free testosterone (cFT), bioavailable testosterone (BT) levels and safety parameters. Results: During the study period, significant time-dependent interactions were found for mFT and cFT levels (within Placebo and IND9 supplemented arms), BT levels (within IND9 but not in Placebo arm) and TT levels (none of the arms). Two-way ANOVA of data of change from baseline at 10 h showed no significant interactions between the treatments and periods (absence of crossover effect) for all measures. Pairwise comparisons between change from baseline data (at 10 h) by unpaired ‘t' test showed significant increase in TT, BT and cFT but not in mFT levels in IND9 arm as compared to respective levels in placebo arm. The supplementation of IND9 and placebo was found to be safe and well-tolerated. All values were found within physiological limits. Conclusion: Acute administration of IND9 capsule supplementation to sedentary males showed potential androgenic benefits with good safety profile. Keywords: Fenugreek seed extract, serum testosterone, Bioavailable, healthy sedentary subject

PRENATAL DEVELOPMENTAL TOXICITY EVALUATION OF FUROSTANOL SAPONIN GLYCOSIDE BASED STANDARDIZED FENUGREEK SEED EXTRACT DURING ORGANOGENESIS PERIOD OF PREGNANCY IN RATS

Objective: To evaluate prenatal safety of furostanol saponin glycoside based standardized fenugreek seed extract (Fenu-FG) on pregnant female Wistar rats on embryo–fetal development organogenesis period in accordance with OECD guideline (No. 414).Methods: Fenu-FG was administered to pregnant rats by gavage at 250, 500, and 1000 mg/kg/day over the exposure period of gestational days 5–19. The vehicle control (VC) group was also maintained. All dams were subjected to a cesarean section on gestational day 20 and the fetuses were examined for external, visceral, and skeletal alterations.Results: There was no significant difference found during maternal examination (body weights, food consumption, numbers of pregnant and non-pregnant female rats) or reproductive parameters (gravid uterus weights, litter size and weights, number of fetuses, sex ratio (male/female numbers of implantations and resorption, number of implantation per female, pre-and post-implantation loss (%), dead and live fetuses (%), numbers and weights of corpora lutea) in Fenu-FG-treated as compared to VC group. Furthermore, the few incidental and non-significant malformations were observed in Fenu-FG-treated as well as VC group during external, visceral or skeletal examinations.Conclusion: The prenatal oral exposure of Fenu-FG during organogenesis period to pregnant female rats was devoid of maternal or developmental (fetotoxicity or teratogenicity) with "No Observed Adverse Effect Level†(NOAEL) greater than 1000 mg/kg

Glycosides based standardized fenugreek seed extract ameliorates bleomycin-induced liver fibrosis in rats via modulation of endogenous enzymes

Background: Liver fibrosis a complex process of excess collagen deposition resulted in disturbance of hepatic cellar function. Glycosides based standardized fenugreek seed extract (SFSE-G) has potent anti-inflammatory, antioxidant, and anti-fibrotic properties. Objective: The aim of this study is to evaluate the hepatoprotective potential of SFSE-G against bleomycin (BLM)-induced liver fibrosis in laboratory animals. Materials and Methods: Sprague-Dawley rats (180–220 g) were assigned to various groups, namely, normal, sham, BLM control, SFSE-G (5, 10, 20, and 40 mg/kg, p.o.), methylprednisolone (10 mg/kg, p.o.), and sildenafil (25 mg/kg, p.o.). Liver fibrosis was induced in various groups (except normal and sham) by single intratracheal BLM (6 IU/kg) injection. Various biochemical, molecular (reverse transcription polymerase chain reaction) and histological parameters were evaluated. Results: Intratracheal BLM administration caused significant induction (P < 0.001) of hepatotoxicity and liver fibrosis reflected by elevated levels of serum aspartate transaminase (AST), alanine transaminase (ALT), total as well as direct bilirubin, and gamma-glutamyl transferase (GGT). Administration of SFSE-G (20 and 40 mg/kg, p.o.) significantly reduced (P < 0.001) levels of AST, ALT, and GGT and significantly increased (P < 0.001) the level of serum albumin. BLM-induced elevated liver oxidative stress and decreased total antioxidant capacity was significantly restored (P < 0.001) by SFSE-G (20 and 40 mg/kg) treatment. It also significantly inhibited BLM-induced alteration in liver Farnesoid X receptor (FXR) mRNA expression. SFSE-G treatment reduced histopathological alteration induced by BLM in liver. Conclusion: SFSE-G exerts its hepatoprotective potential via inhibition of oxido-nitrosative stress and modulation of FXR mRNA expression thus ameliorates BLM-induced liver fibrosis