Hypogonadism Clinical Trial
Official title:
Efficacy Evaluation of Furosap, a Testosterone Booster Supplement in Human Volunteers : An add-on Study
The study evaluates the effect of Fenugreek seed extract (Furosap) in management of symptomatic hypogonadism as fenugreek seed extract is a testosterone booster. Fenugreek seeds extract are known to possess protodioscin and the extract is reported to improve sperm count, sperm morphology and protective effect on male reproductive system. All the participants will receive one capsule (500 mg) of furosap once a day.
Testosterone deficiency (hypogonadism) is increasingly recognized as a significant health
problem in aging men. Testosterone deficiency can adversely affect sexual function, physical
health and psychological health. Consequently, the quality of life of men with low
testosterone is negatively affected.
A certain proportion of middle-aged and elderly men have total testosterone concentrations
below the reference range for young adult males. Possible consequences of reduced androgen
levels include fat mass gain, loss of muscle and bone mass, fatigue, depression, anaemia,
poor libido and erectile dysfunction. The clinical features of androgen deficiency in the
aging male (ADAM) resemble those of hypogonadism of younger subjects, with a single relevant
difference: each of these features can also occur in elderly men with normal androgen levels.
The world Health Organization estimates that by 2025, worldwide, the number of people aged
over 65 years will rise from the current figure of 390 million to 800 million. In the
Hypogonadism in Males (HIM) study of men treated in the primary care setting, 38.7% of men
aged ≥45 years tested positive for hypogonadism (TT <300 ng/dL). Applied to U. S. census
data, these findings suggest that 13.8 million American men aged ≥45 years may be
testosterone- deficient. Furthermore, the prevalence of testosterone deficiency increases
with age, reaching 50% for men aged ≥85 years. As the population ages, the burden of
testosterone deficiency is expected to grow. The prevalence of low testosterone also
increases in men with common co- morbidities, such as obesity, diabetes, and metabolic
syndrome.
The nutritional status with an age is a major determinant of health and fitness. Nutrition
plays a central role in adaptation, rehydration, refueling, and repair as well as recovery
from injury and other problems. The testosterone supplementation in older men with low
testosterone levels may improve the testosterone level which further improve the physical,
sexual, and cognitive functions, and improve mood and quality of life
FUROSAP® is an innovative product made through a novel patented process, involving physical
separations of active ingredients from the seeds of Fenugreek herb (Trigonella
foenum-graecum) without affecting chemical properties of the active fractions. It is a
natural and promising dietary supplement. It‟s dietary supplement comprising Protodioscin as
the major fraction which isolated from fenugreek seeds.
Protodioscin is the active ingredient found in the extract of the plant. Protodioscin
increases levels of the hormones testosterone, dihydrotestosterone and
dehydroepiandrosterone. It boosts testosterone level via stimulating pituitary gland.
Protodioscin acts by stimulating the enzyme 5- alpha-reductase, which plays a role in the
conversion of testosterone into dihydrotestosterone. Dihydrotestosterone, in turn enhances
erythropoiesis and muscle development. More erythropoiesis or production of red blood cell
increases the haemoglobin level, which results in better oxygen transport throughout the
body, resulting in a more optimal health. Both increased production of testosterone
contribute to the increase in sexual functions, and it increases unbound free testosterone
levels, which improves muscle mass, fat loss, strength and endurance. In addition,
protodioscin also stimulates the hypothalamus secretion of luteinizing hormone (LH) which
also helps to increase the level of testosterone.
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