Obesity is growing around the world in epidemic proportions. Diabetes follows obesity by approximately 10 years and the prevalence of diabetes is growing rapidly as well. Not only are diabetes and obesity associated with much suffering and disease, they are also expensive and threaten the economics of public health systems globally. Obesity medications give modest weight loss at best. Diet and lifestyle change are the basis of obesity treatment, and the growing obesity epidemic is testimony to their limitations. Obesity is a stigmatized condition. The fat in obesity is usually concentrated around the waist or at the hips and thighs. Women with lower body obesity become discouraged and may stop dieting, because fat is lost predominantly from their breasts which they often feel are too small, and not from their hips and thighs where they would prefer to lose it. Local fat reduction represents a way that people can direct the area from which fat is lost which gives them control over their own anthropometry. This ability can encourage subjects to remain in weight loss programs for longer periods of time, lose more weight and improve their health to a greater degree. There have been several approaches to local fat reduction. Invasive approaches include plastic surgery and liposuction. Mesotherapy, the injection of lipolytic stimulators or substances that destroy fat cells subcutaneously, is a less invasive method of removing fat locally. The least invasive approaches are low energy laser treatments that release fat from fat cells through the creation of pores in the cell membranes or topical creams containing lipolytic substances that cross the skin into the fat tissue. Although one might be tempted to dismiss all these methods as being cosmetic without any medical benefit, directing the areas from which fat is lost during a weight loss program is encouraging to many obese subjects, improves their self-image and gives them the motivation to continue losing weight for a longer period of time. Longer weight loss programs are associated with greater weight loss and greater health benefits. We hope this chapter allows a risk-benefit assessment of the different methods of local fat reduction. We also hope this chapter makes a case for the benefits of directing the area from which fat is lost during a weight loss program, potentially leading to longer and greater fat loss with a commensurate increase in medical benefits.
IntroductionAn orally administered amino acid-based test supplement was recently shown to increase human growth hormone (hGH) in healthy adults. This prospective, observational, single-center, single-arm cohort study investigated the effects of 24 weeks of daily oral administration of the test supplement in individuals with stress-related weight gain, fibromyalgia (FM) and stress-related low-normal hGH production (15-30th percentile for age-appropriate levels) on insulin-like growth factor 1 (IGF-1), an indicator of hGH levels caused by stress related stimulation of somatostatin.MethodsParticipants continued to receive standard care. The primary endpoint was the change from baseline to endpoint (Week 24) in serum IGF-1. Additional endpoints included the change in body weight, clinical symptoms (assessed with the Revised Fibromyalgia Impact Questionnaire [FIQR], range 0-100, and Perceived Stress Scale [PSS], range 0-40), fasting cardiometabolic markers, tolerability, and safety. The study enrolled 84 fibromyalgia patients with low-normal age-adjusted IGF-1 serum levels. High mean ± Standard Deviation (SD) baseline FIQR and PSS scores of 76 ± 16 and 32 ± 5, respectively, indicated poor to moderate symptom management with standard care. All individuals completed 24 weeks.ResultsSerum IGF-1 levels increased with a Week 24 mean± Standard Error (SE) change of 28.4 ± 3.0 ng/mL (p<0.001). Body weight was reduced with a Week 24 mean ± SE change of -5.5 ± 0.3 kg (p<0.001) (a 6.5% weight loss from baseline). The change from baseline in FIQR and PSS scores were -29.1 ± 1.1 and -20.0 ± 0.8, respectively (both p<0.001), indicating a substantial improvement. Statistically significant improvements from baseline to Week 24 were observed in systolic and diastolic blood pressure, HbA1c, LDL and HDL cholesterol, and triglycerides (all p<0.001). The supplement was well tolerated; no adverse events were reported.DiscussionSustained augmentation of IGF-1 with the test supplement may represent a novel method of improving clinical symptoms, including stress-related weight gain, in individuals with fibromyalgia and stress-associated low-normal hGH.
Fibromyalgia is a chronic pain sensitivity disorder that affects approximately 3-8% of the general population with symptoms that include fatigue and widespread musculoskeletal pain. Psychological and physical stressors are frequent drivers of fibromyalgia, and additional lockdown-associated stressors may worsen symptoms. Reduced production of human growth hormone (hGH) is evident in approximately 30% of individuals with fibromyalgia, which is hypothesized to contribute to common fibromyalgia symptoms. An orally administered amino acid supplement has been previously shown to improve endogenous hGH status in adults. We investigated if daily administration of the supplement would increase levels of endogenous insulin-like growth factor 1 (IGF-1), a surrogate marker of the body's hGH levels, and improve symptoms related to low-normal hGH production in a cohort of 84 individuals being treated for fibromyalgia. This is the full-cohort analysis of an open-label, single-arm study that investigated the effects of 24 weeks of daily oral administration of the supplement in individuals with low-normal hGH production. The primary endpoint was the change from baseline to endpoint (Week 24) in serum IGF-1. Additional endpoints included the change in body weight, clinical symptoms (assessed with the Revised Fibromyalgia Impact Questionnaire [FIQR], range 0-100, and Perceived Stress Scale [PSS], range 0-40), fasting cardiometabolic markers, tolerability, and safety. Participants continued to receive standard care. The study enrolled 84 fibromyalgia patients with low-normal age-adjusted IGF-1 serum levels. High mean±SD baseline FIQR and PSS scores of 76±16 and 32±5, respectively, indicated poor to moderate symptom management with standard care. All individuals completed 24 weeks of treatment. Serum IGF-1 levels increased with a Week 24 mean±SE change of 28.4±3.0 ng/mL (paired t-test p<0.001). Body weight was reduced with a Week 24 mean±SE change of -5.5±0.3 kg (p<0.001). The change from baseline in FIQR and PSS scores were -29.1±1.1 and -20.0±0.8, respectively (both p<0.001), indicating a substantial improvement. Statistically significant improvements from baseline were also observed for systolic and diastolic blood pressure, HbA1c, LDL and HDL cholesterol, and triglycerides (all p<0.001). The supplement was well tolerated; no adverse events were reported. Sustained augmentation of IGF-1 with the supplement may represent a unique method of improving clinical symptoms of fibromyalgia in individuals with low-normal hGH production. Presentation: Monday, June 13, 2022 12:30 p.m. - 2:30 p.m.
SeroVital is an orally-administered amino acid supplement that promotes hGH secretion via suppression of somatostatin. We investigated if daily administration of the supplement would increase levels of endogenous insulin-like growth factor 1 (IGF-1), a primary mediator of the effects of hGH, and improve symptoms related to low-normal hGH production in a cohort of individuals being treated for fibromyalgia, a complicated condition associated with endocrine features including low or low-normal hGH. This open-label, single-arm study investigated the effects of 24 weeks of daily oral administration of the supplement in individuals with low-normal hGH production (between the 15th and 50th percentile for age-appropriate levels of IGF-1). The primary endpoint was the change from baseline to endpoint (Week 24) in serum IGF-1. Additional endpoints included the change in body weight, clinical symptoms (assessed with the Revised Fibromyalgia Impact Questionnaire [FIQR], range 0-100, and Perceived Stress Scale [PSS], range 0-40), fasting cardiometabolic markers, tolerability, and safety. Participants continued to receive standard care. The study enrolled 45 adults with mean baseline age (mean±SD) 67±11 years, 67% female, BMI 31±7 kg/m2, and IGF-1 107±28 ng/mL. High mean±SD baseline FIQR and PSS scores of 82±14 and 35±3, respectively, indicated poor to moderate control of fibromyalgia with standard care. All individuals completed 24 weeks of treatment. There was an increase in serum IGF-1 levels at Week 12 that was sustained to endpoint, resulting in a mean±SE Week 24 change of 32.1±2.8 ng/mL (paired t-test p<0.001). IGF binding protein-3 (IGFBP-3) levels were unchanged from baseline (p=ns), indicating no change in IGF-1 sensitivity. There was a steady reduction in body weight that resulted in Week 24 mean±SE change of -6.4±0.4 kg (p<0.001). The change from baseline in FIQR and PSS scores were -25.6±1.6 and -21.5±0.5, respectively (both p<0.001), indicating a substantial improvement. Statistically significant improvements from baseline were also observed for systolic and diastolic blood pressure, HbA1c, LDL and HDL cholesterol, and triglycerides (all p<0.001). The supplement was well tolerated; no adverse events were reported. In patients being treated for fibromyalgia with low-normal hGH production, daily addition of the hGH-enhancing supplement for 24 weeks produced an increase in IGF-1 with associated weight loss and improvements in cardiometabolic markers and clinical symptoms. Sustained augmentation of IGF-1 with the supplement may represent a unique method of improving clinical symptoms in individuals with low-normal hGH, including otherwise healthy adults exhibiting low-normal hGH production.This was an independent investigator-initiated study. Sierra Research Group provided some samples of the supplement.
Post-traumatic stress disorder (PTSD) and fibromyalgia (FM) are multisystem disorders with endocrine features including low levels of steroid hormones and insulin resistance. Dysregulation of neuroendocrine pathways is implicated in the pathogenesis of PTSD and FM. Zadiol(TM) is an orally administered investigational dietary supplement containing 3 active ingredients (isoflavones from the Red Clover plant, [R+] alpha lipoic acid, and L-DOPA derived from the legume Mucuna pruriens ) that are hypothesized to normalize steroid hormone signaling. We investigated the effects of the supplement on clinical symptoms and hormones in adults with treatment-resistant PTSD or PTSD and FM (PTSD+FM). This was a single-center, open-label, uncontrolled pilot study. Eligible adults (18-70 years) received the supplement orally once daily for 3 months. The primary outcomes were the change from baseline to endpoint (3 months) in PTSD and FM symptoms, assessed with the self-report questionnaires: PTSD checklist for DSM-5 (PCL-5; range 0-80) and Revised Fibromyalgia Impact Questionnaire (FIQR; range 0-100). Additional endpoints included the change from baseline to endpoint in sleep quality measured by actigraphy, steroid hormones, insulin, Perceived Stress Scale (PSS; range 0-40), and adverse events. For all questionnaires, higher score indicates greater symptom severity. Fasting blood samples were collected in the AM. The study included 10 individuals with PTSD; 5 also had FM. The majority were female (7/10) with mean age 65 years and BMI 32 kg/m 2 . After 3 months of treatment, mean±SD PCL-5 score was 26±19, an improvement from the baseline score of 48±14 (p<0.001). The change was similar for individuals with PTSD and PTSD+FM (both p<0.05). In individuals with PTSD+FM, baseline FIQR score was 48±22 (indicating presence of FM symptoms) and 11±6 at endpoint, indicating improved FM symptoms (p<0.01). In females, mean estradiol was increased from baseline (p<0.01) and there was a trend for decreased testosterone (p=0.06). In males and females, mean cortisol was normal at baseline (9±4 µg/dL) and was unchanged at endpoint. Insulin was reduced from baseline (18±13 µIU/mL) to endpoint (6±3 µIU/mL, p<0.05). There was a nonsignificant improvement in PSS score from 20±8 at baseline to 15±9 at endpoint, as well as nonsignificant decreases in the number of awakenings and mean time during awakenings. There was also a trend for reduced diastolic and systolic blood pressure. The supplement was well tolerated; no adverse events were reported. The results of this pilot study in individuals with treatment-resistant PTSD and FM suggest the supplement resulted in an improvement in PTSD and FM symptoms as well as improvements in gonadal steroids and insulin. Further investigation of the efficacy and mechanism of action of Zadiol is warranted. The study was funded by Bioimmunity, Inc.
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