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Clinical Studies
Effect of Genesis GoldÒ on Hypothalamic Dysregulation. Maragopoulos, D. 2010
Abstract
Background: Hypothalamic dysfunction is becoming recognized as the underlying issue in neuro-immune-endocrine imbalance. The hypothalamus produces proopiomelanocortin (POMC)- a 256 amino acid regulating hormone that signals the pituitary gland to produce stimulating hormones to regulate the adrenals and thyroid, as well as directly stimulates the pancreas to produce insulin. After POMC breaks down to cortico-releasing factor, thyroid releasing factor, pancreatic releasing factor, the remaining amino acids become beta-endorphins. Hypothalamic dysregulation is characterized by febrile temperature swings, glucose intolerance, imbalanced hypothalamic-pituitary-adrenal axis and hypothalamic-pituitary-thyroid axis. In order to determine hypothalamic dysfunction, serum levels of DHEA-S, TSH, Free T4, Free T3, and C-peptide will fall into suboptimal ranges for age and gender. In addition, patients with hypothalamic dysfunction often suffer from extreme temperature swings and show signs of mild depression.
Objective: It was determined whether dietary supplementation with Genesis Gold could improve hypothalamic dysregulation.
Design: Twenty one volunteers with evidence of hypothalamic dysfunction (age range: 19-72 y: median: 39 y) participated in consuming dietary supplementation for at least six months. Baseline reporting of hypothalamic dysregulation symptoms specifically—hot flashes, night sweats, lack of motivation, loss of libido, and depressed affect. Baseline serum levels of DHEA-S, TSH, Free T4, Free T3, and C-peptide were determined. All subjects began the study with low levels of DHEA-S, subclinical hypothyroidism or discordinate TSH and Free T4/T3 levels, and high levels of C-peptide. All subjects reported at least three out of five symptoms of hypothalamic dysregulation affecting them on average 20 days per month (range 15-30) Genesis Gold was consumed daily at 3 gms/50 # of body weight.
Results: Serum levels of DHEA-S, TSH, Free T4, Free T3, and C-peptide optimized in 18 subjects after six months. The three remaining subjects showed improvement in all serum levels with suboptimal levels of DHEA-S. Hypothalamic deregulation symptoms improved in all subjects from baseline including elevation of mood and motivation, and increase in sex drive. All subjects noted complete eradication of temperature dysregulation. Although the three subjects with suboptimal DHEA-S levels reported improvement of libido, sex drive had not normalized for them at six months.
Conclusion: Genesis Gold could be an effective dietary supplement to improve hypothalamic dysregulation.
Enhancement of immunity in teachers and students by dietary supplementation with Genesis GoldÒ. Maragopoulos, D. 2010
Abstract
Background: Stress and poor nutrition can lead to a decline in immunity increasing vulnerability to airborne viruses. Teachers and students are particularly at risk especially in the late fall and early winter. Loss of classroom time due to upper respiratory illness can be as high as 6 days per month. This at risk population could benefit from safe and effective interventions that restore immune function.
Objective: It was determined whether dietary supplementation with Genesis GoldÒ could enhance immunity in subjects with high exposure to upper respiratory viruses.
Design: Thirty-four healthy volunteers (age range: 18-68 y: median: 38 y)
participated in a three month dietary supplementation at the beginning of school year (October through January). Baseline reporting of upper respiratory infections averaged 5 URI's (range 2-11) per first semester of the previous three school years averaging 2 days absence per month. Twenty cases of influenza were also reported over the past three years. Genesis GoldÒ was consumed daily at 3 gms/50 # of body weight. Records of URI's were kept during the three month study period.
Results: Decreases in the number of URI's were noted. On average one URI (range of 0-3) reported during study period averaging 0.3 day absence per month (range 0-3). Of note, there were no reports of influenza, which is significant as the study was held during the 2009 H1N1 influenza outbreak.
Conclusion: Genesis GoldÒ could be an effective dietary supplement to enhance immunity to common respiratory viruses in at risk populations.
Conception by infertile women using dietary supplementation with Genesis GoldÒ. Maragopoulos, D. 2010
Abstract
Background: Infertility affects one out of -----women. The high cost and high risk of invasive infertility treatments leads women to seek more natural approaches to conceive.
Objective: We determined whether dietary supplementation with Genesis GoldÒ could enhance fertility in women.
Design: Nine healthy volunteers (age range: 28-42: median: 36 y)
participated in a three month dietary supplementation to enhance hypothalamic response and thus conceive without fertility treatments. All subjects had a diagnosis of primary infertility on average of 6 years (range 2 - 24 years). Seven women were nulliparous, two had previous full term pregnancies—one by in vitro fertilization, one by artificial insemination. Genesis GoldÒ was consumed daily at 3 gms/50 # of body weight.
Results: Conception occurred in all subjects within 2- 6 months of consumption of Genesis GoldÒ. All pregnancies came to term. Six women continued consuming Genesis GoldÒ throughout their pregnancies. Of note, the two parous women reported easier pregnancies with no gestational diabetes or hypertension.
Conclusion: Genesis GoldÒ could be an effective dietary supplement to enhance fertility in infertile women.
Effect of Genesis GoldÒ on addiction. Maragopoulos, D. 2010
Abstract
Background: Addiction to chemicals whether prescribed or illicit is a growing health problem. Addiction is characterized by physiological and psychological dependency on a chemical substance. The lives of addicts and their families are adversely affected by their addiction. While there are many psycho-social support programs like Alcoholics Anonymous (AA) and some prescription therapies like methadone, there are few natural remedies that address the complex nature of addiction. Detoxification and neuro-endocrine support are crucial in helping addicts come off their drugs of choice.
Objective: It was determined whether dietary supplementation with Genesis Gold could assist addicts in staying sober.
Design: Seven volunteers (age range: 34-48y: median: 40y) participated in consuming dietary supplementation for at least six months. Addictions included dependency on methadone, cocaine, alcohol, benzodiazepines and opiates. Volunteers were all in AA, but wished additional biochemical support to stay sober. Baseline reporting of chemical use was determined. Days of sobriety immediately prior to study ranged from 1-40 days with a median of 12 days. Genesis GoldÒ was consumed daily 3 gms/50 # of body weight.
Results: Within two weeks of consuming Genesis GoldÒ, all subjects were able to maintain sobriety. All experienced detoxification reactions of increased urination and defecation, acne and dermatitis in the first six weeks. All reported increase in energy and deeper sleep with increased dream recall. Only one subject had a relapse on day 98 which she related to a week lapse in supplement consumption. All subjects continue to consume Genesis GoldÒ with past the closure of the study.
Conclusion: Genesis GoldÒ could be an effective dietary supplement to assist addicts in maintaining sobriety.
Improvement of menopausal symptoms by dietary supplementation with Genesis GoldÒ. Maragopoulos, D. 2009
Abstract
Background: The cessation of adequate sex steroid production at menopause causes a variety of symptoms including insomnia, hot flashes, night sweats, vaginal dryness, loss of libido, memory loss, mood swings, dry skin and hair. Since the closure of the Women's Health Initiative study in 2005, many menopausal and perimenopausal women are seeking natural means to thrive during menopause.
Objective: It was determined whether dietary supplementation with Genesis GoldÒ could improve menopausal symptoms.
Design: Fifty-four healthy volunteers (age range: 42-58 y: median: 52 y) participated in consuming dietary supplementation for at least six months. Baseline reporting of menopausal symptoms and serum FSH levels were determined. Follicle Stimulating Hormone levels averaged 54ng/dl with a range of 32-116ng/dl. Genesis GoldÒ was consumed daily 3 gms/50 # of body weight.
Results: Decreases in the number of menopausal symptoms were noted. Significantly less insomnia, hot flashes and night sweats within the first three weeks. With improvement in memory, libido and vaginal dryness within six to eight weeks. Improvement in skin and hair was noted within eight to twelve weeks. FSH levels dropped with an average of 38 (range of 25- 60) within six months. Two subjects participants dropped out in the first month due to abdominal bloating and flatulence. Stool tests confirmed overgrowth of candida species. Both subjects were treated and resumed consumption of Genesis GoldÒ without side effects.
Conclusion: Genesis GoldÒ could be an effective dietary supplement to improve symptoms in menopausal women.
Improvement of thyroiditis by dietary supplementation with Genesis GoldÒ. Maragopoulos, D. 2009
Abstract
Background: Thyroiditis is an autoimmune condition characterized by elevations in antithyroid antibodies specifically—thyroid peroxidase antibody (TPO ab) and thyroglobulin antibody (TGB ab). Thyroiditis can lead to clinical hypothyroidism. Conventional medicine treats thyroiditis once it affects thyroid hormone production. Patients suffering from thyroiditis often complain of hypothyroid symptoms but do not have low levels of thyroxine (T4) or elevations of thyroid stimulating hormone (TSH). Hypothyroid symptoms include fatigue, weight gain, constipation, dry skin, cold hands and feet. Basal body temperatures reflect leiothyronine (T3) activity. Basal body temperatures (BBT) are often low in thyroiditis patients well before serum levels reflect hypothyroidism.
Objective: It was determined whether dietary supplementation with Genesis GoldÒ could improve thyroiditis.
Design: Eight volunteers (age range: 44-62y: median: 54y) participated in consuming dietary supplementation for eighteen months. Baseline serum thyroid and thyroid antibodies levels were determined as well as basal body temperatures. Although all patients were euthyroid by conventional standards (TSH and T4 levels normal), all had elevations of TPO and TGB antibodies, averaging 180 and 125. (Normal antibody levels are below 60) All patients showed some degree of discordance between TSH and free T4/T3 levels. Basal body temperatures averaged 97.2 (range 96.4 to 97.8, normal BBT 97.8-98.2 degrees Fahrenheit) Genesis GoldÒ was consumed daily 3 gms/50 # of body weight. Serum levels of thyroid hormones and antibodies were measured every three months. Basal body temperatures were taken monthly.
Results: Within two months of consumption of Genesis GoldÒ, basal body temperatures rose (average 97.8) with complete normalization by month six. Thyroid hormone panels showed steady improvements at three, six and nine months with all patients plateauing at twelve months to optimal TSH-T4/T3 balance. By eighteen months thyroid antibodies had dropped significantly to an average of 70 TPO ab (range 40-90) and 50 TGB ab (range 35-75).
Conclusion: Genesis GoldÒ could be an effective dietary supplement to improve thyroiditis and subclinical hypothyroidism.
Effect of Genesis GoldÒ on lipids. Maragopoulos, D. 2008
Abstract
Background: Steroid hormones are produced from cholesterol molecules specifically LDL. Adrenal stress, perimenopause, menopause and andropause are associated with elevations of LDL cholesterol. Once hormonal balance is restored, LDL cholesterol lowers.
Objective: It was determined whether dietary supplementation with Genesis Gold could improve lipid profile.
Design: Thirteen healthy volunteers (age range: 45-55y: median: 51y) participated in consuming dietary supplementation for at least three months. Baseline serum lipid levels were determined—including total cholesterol, LDL, triglycerides and HDL. All subjects showed elevation of LDL cholesterol (average 140) and triglycerides (average 150) and low levels of HDL comparatively (average 40) with elevated total cholesterol (average 225) Genesis GoldÒ was consumed daily 3 gms/50 # of body weight.
Results: At 90 days, serum lipid levels showed marked improvements. While total cholesterol showed modest improvements (average 210), LDL and triglycerides had decreased to optimal levels. LDL cholesterol averaged 110 while triglycerides averaged 90. HDL levels rose to an average of 55 improving Total/HDL ratio dramatically.
Conclusion: Genesis GoldÒ could be an effective dietary supplement to improve lipid profiles—specifically raising HDL cholesterol while lowering LDL and triglycerides.
Effect of Genesis GoldÒ on menopausal women. Maragopoulos, D. 2009
Abstract
Background: The cessation of adequate sex steroid production at menopause causes a variety of symptoms including insomnia, hot flashes, night sweats, vaginal dryness, loss of libido, memory loss, mood swings, dry skin and hair. Since the closure of the Women's Health Initiative study in 2005, many menopausal women are seeking natural means to thrive during menopause.
Objective: It was determined whether dietary supplementation with Genesis GoldÒ could be a viable option for menopausal women who do nto wish to take hormone replacement therapy.
Design: Twenty-four healthy female volunteers (age range: 48-54 y: median: 51 y) participated in the study for six months. Half the women were prescribed bio-identical hormone replacement therapy (BHRT), the other half consumed Genesis GoldÒ. All women were menopausal as determined by elevated FSH levels greater than 30ng/dl on two draws at least two months apart. Baseline reporting of menopausal symptoms was determined. The BHRT group received transdermal progesterone cream 100mg/day and transdermal estradiol 2mg/day. The Genesis GoldÒ group consumed 3 gms/50 # of body weight daily.
Results: All participants noted decrease in the number of menopausal symptoms, including reduction in hot flashes and night sweats, improved quality of sleep and less daytime fatigue, increased libido and less vaginal dryness, less moodiness and improved memory. The supplement group reported no side effects but did not achieve cessation of hot flashes and night sweats as quickly as the BHRT group (difference of 13 days). The BHRT group reported breast tenderness and bloating which resolved after the second month of treatment, and weight gain (average of 3 pounds) which did not resolve while on BHRT.
Conclusion: Genesis GoldÒ could be an effective alternative to improve menopausal symptoms for those women opting not to use hormone replacement therapy.
Improvement of fatigue by dietary supplementation with Genesis GoldÒ. Maragopoulos, D. 2008
Abstract
Background: Clinically, complaints of fatigue are a growing issue for primary care providers. Fatigue has many possible etiologies and may be a symptom of a number of diseases. Oftentimes conventional workups are not able to uncover the root of the problem. Many fatigued patients seek alternative care. Fatigue is characterized by lack of energy and daytime sleepiness which interferes with normal daily function.
Objective: It was determined whether dietary supplementation with Genesis GoldÒ could improve daytime fatigue.
Design: Sixteen healthy volunteers (age range: 24- 40y: median: 34y) participated in consuming dietary supplementation for 30 days. Subjects ceased consumption for a month, then resumed consumption for a second 30 days. Baseline reporting of symptoms and serum chemistry, TSH, DHEA-S levels were determined. All blood levels were within optimal ranges. Fatigue symptoms were categorized on a scale of 1-10 with 10 equating to the most amount of energy enabling the subject to complete activities of daily living and 1 equating to needing to sleep more than 50% of wakening hours. On average subjects reported 3 in energy level with a range of 1-6. Fatigue levels were reported weekly. Genesis GoldÒ was consumed daily at 3 gms/50 # of body weight.
Results: Fatigue levels began to drop by 50% in week two of consumption of Genesis GoldÒ. By week four, subjects reported an increase in energy (average energy at 7 with range from 5-9). During the washout period, fatigue symptoms resumed within two weeks to baseline energy of 3. In the second month of Genesis GoldÒ consumption, subjects reported increases in energy with an average level of 7. There were no significant changes in blood values at the end of the study period.
Conclusion: While fatigue may be a symptom of many diseases, Genesis GoldÒ could be an effective dietary supplement to improve energy..
Effect of Genesis GoldÒ on irritable bowel syndrome. Maragopoulos, D. 2008
Abstract
Background: Irritable Bowel Syndrome (IBS) is characterized by intestinal discomfort and spasms associated with abnormally slow or rapid motility. IBS is a diagnosis of exclusion and has been treated with antispasmodics and SSRI's. Due to its possible neuro-endocrine nature, IBS may be ameneable to nutritional supports that target the neuro-endocrine system.
Objective: It was determined whether dietary supplementation with Genesis Gold could improve irritable bowel syndrome.
Design: Eight healthy volunteers (age range: 29-46y: median: 36y) participated in consuming dietary supplementation for three months. Baseline reporting of IBS symptoms including episodes of diarrhea, constipation, abdominal pain and intestinal spasms were determined. On average, subjects reported daily episodes of IBS symptoms with as many as six episodes of spasms per day. Subjects were asked to rate abdominal pain on a scale of 1-10 with 10 being the worst. Baseline pain levels averaged 7 with a range of 4-9. Genesis GoldÒ was consumed daily 3 gms/50 # of body weight and subjects were asked to record IBS symptoms daily.
Results: By day 13, IBS symptoms were reduced by 60% (0-3 episodes per day with a pain rating averaging 3) At the study's end, subjects had experienced on average 44 days free of IBS symptoms. (range 20-70). Subjects with slow motility (constipation) and rapid motility (diarrhea) had daily normally formed bowel movements by the fourth week of consumption.
Conclusion: Genesis GoldÒ could be an effective dietary supplement to improve irritable bowel syndrome.
Improvement of insomnia by dietary supplementation with Genesis GoldÒ. Maragopoulos, D. 2008
Abstract
Background: Insomnia is a growing problem in modern society. Insomnia is defined as less than seven hours of uninterrupted sleep a night. Use of prescription and over the counter sleep aids are at an all time high. Many of the agents used for insomnia do not induce deep sleep which can cause daytime fatigue. Serum prolactin levels are often elevated in the daytime in chronic insomnia. Optimal levels of serum prolactin range between 6-9g/dl at 9 am after 7-9 hours of uninterrupted sleep.
Objective: It was determined whether dietary supplementation with Genesis GoldÒ could improve insomnia.
Design: Thirty healthy volunteers (age range: 36-66 y: median: 50 y) participated in consuming dietary supplementation for two months. Baseline reporting of insomnia including hours of uniterrrupted sleep (average 3hr/night), dream recall (average 1 dream recalled per month), feeling rested upon awakening (average 2 on a scale of 1-10 with 10 being most rested) and level of daytime energy average of 3 on a scale of 1-10 with 10 being the most energy) were determined. Baseline serum prolactin levels were drawn at 9am (average 18 ng/dl). Genesis GoldÒ was consumed daily at 3 gms/50 # of body weight and subjects were asked to keep a daily record of hours of sleep, dream recall, feeling rested and daytime energy.
Results: Twenty-eight subjects had improvement of insomnia by week three, while the remaining two subjects improved by week five. At the end of the study, the average hours of uninterrupted sleep increased to 6 (range of 5-8), dream recall increased to twice weekly (range 1-4 times per week), feeling rested upon awakening improved from an average of 2 to 6 and daytime energy increased from 3 to 7. Serum prolactin levels dropped to 11 with a range of 8- 14 ng/dl.
Conclusion: Genesis GoldÒ could be an effective dietary supplement to improve insomnia.
Effect of Genesis GoldÒ on learning disabilities. Maragopoulos, D. 2007
Abstract
Background: Learning disabilities affect one out of five children. From autistic spectrum disorder to attention deficit disorder, learning disabilities profoundly affect children, families and the educational system. Many parents seek nondrug alternatives to treating their learning disabled children. Nutritional supplementation focusing on the hypothalamus and the neuro-immune-endocrine system could improve focus and concentration in learning disabled children.
Objective: It was determined whether dietary supplementation with Genesis Gold could improve learning disabled children's function.
Design: Six healthy volunteers (age range: 6-13y: median: 9y) participated in consuming dietary supplementation for six months. Baseline assessments of the children by parents and teachers were determined. Staying on task averaged 8 minutes with a range of 2 -18 minutes. Emotional lability averaged 8 on a scale of 1-10 with 10 being the most emotionally labile. Genesis GoldÒ was consumed daily 3 gms/50 # of body weight. Teachers and parents kept weekly records of children's function.
Results: By week four, most of the children had improvements in focus, attention, staying on task. By week seven all children had improved in function and less emotional labiality. Parents were creative in administering Genesis GoldÒ to their children as the green-herbal taste required masking. Honey or vanilla flavored yoghurt masked the taste best. After the first two weeks of the study, most of the children readily consumed the supplement. Parents noted improvements in their children's mood and attitude.
Conclusion: Genesis GoldÒ could be an effective dietary supplement to improve learning disabilities in children.
Effect of Genesis GoldÒ on anxiety. Maragopoulos, D. 2009
Abstract
Background: Anxiety can be debilitating and difficult to treat. Pharmaceuticals are available but can be sedating. A nutritional supplement that corrects the neurotransmitter imbalance associated with anxiety is desirable.
Objective: It was determined whether dietary supplementation with Genesis GoldÒ could improve anxiety symptoms in adults.
Design: Twelve healthy volunteers (age range:36-52y: median: 44y) participated in consuming dietary supplementation for two months. Baseline reporting of symptoms used Zung self rating anxiety scale (SAS). Subjects scored on average 58 with a range of 45-65. Genesis GoldÒ was consumed daily 3 gms/50 # of body weight. Subjects were asked to rate their symptoms on weekly basis.
Results: Anxiety as rated by the SAS decreased to normal 33 (range 28-35). Most subjects noticed a reduction in anxiety symptoms within the first week with SAS scores stabilizing into normal range by week four.
Conclusion: Genesis GoldÒ could be an effective dietary supplement to improve anxiety.
Improvement of depressive symptoms with Genesis GoldÒ. Maragopoulos, D. 2008
Abstract
Background: Clinical depression can severely inhibit patient function and quality of life. While pharmaceuticals are available to treat depression side effects including decreased energy and libido as well as flat affect can be inhibiting. Natural means to correct neurotransmitter imbalance are desirable.
Objective: It was determined whether dietary supplementation with Genesis GoldÒ could improve depression symptoms in adults.
Design: Twenty healthy volunteers (age range: 26-62y: median: 42y) participated in consuming dietary supplementation for three months. Baseline reporting of symptoms used Zung self rating depression scale. Subjects scored on average 60 with a range of 50-67. Genesis GoldÒ was consumed daily 3 gms/50 # of body weight. Subjects were asked to rate their symptoms bi-weekly.
Results: At the study's conclusion, depression rating dropped by 25% to an average of 45 (range 38-52) placing the majority of subjects within normal range for depression. Most subjects noticed a change in mood within the first three weeks with Zung self rating depression scores dropping steadily.
Conclusion: Genesis GoldÒ could be an effective dietary supplement to improve depression.
See: Bibliography regarding Ingredients in Genesis GoldÒ
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