The effects of Relacore on BMI and serum cortisol. Corinne Buck

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1 The effects of Relacore on BMI and serum cortisol Corinne Buck Biology March 2006

2 The effects of Relacore on BMI and serum cortisol Abstract Increased cortisol secretion has been correlated to increases in obesity. The diet pill, Relacore, marketeded by Klein-Becker, Inc. claims to reduce body fat by controlling stress levels and by lowering cortisol concentrations. The purpose of this research was to study the effects of Relacore on BMI and serum cortisol concentrations. Fifteen collegeaged (20-24 year old) women participated in this study. A repeated measures protocol was employed to evaluate the effects of Relacore on salivary cortisol. Each subject ingested the recommended dosage of four Relacore capsules daily. Cortisol concentrations were measured from saliva samples by enzyme immunoassay. There were no significant changes in BMI as a result of Relacore supplementation (p=0.11). The results of a repeated measures ANOVA indicated no significant differences (p=0.12) in salivary cortisol over the course of the study. It would appear that the marketing claims made by Klein-Becker, in reference to Relacore are misleading. Introduction Obesity is defined as having a body mass index (BMI) over Obesity is one of the leading causes of death in the United States and tends to increase the risk of serious chronic diseases including diabetes, heart disease, arthritis and some cancers (Field et al. 2001). Increased cortisol secretion has been related to obesity in persons with abnormal hypothalamic activity (Jessop et al. 2001, Pasguali et al. 2002, Hershberger et al. 2004). Cortisol is a glucocorticoid that is secreted by the adrenal cortex. Serum cortisol levels have been correlated with age, gender and body fat percentage (Purnell et al. 2004). Cortisol secretion tends to peak in the morning but levels can increase with fasting, food intake, exercise, awakening and psychological stressors (McEwen 1980). Cortisol regulates blood sugar levels and blood pressure, has been shown to have antiinflammatory and immunosuppressive qualities and plays a role in fat deposition in adipose cells located in the abdomen and maturing adipocytes (Epel et al. 2000). Cortisol 1

3 secretion is a major component of stress-related responses such as binge-eating and is associated with patients diagnosed with Cushing s syndrome where fat disposition and weight gain are the primary symptoms (Gluck et al. 2004). The diet pill, Relacore, is marketed by Klein-Becker, Inc. as a means of reducing body fat by controlling stress levels and lowering plasma cortisol concentrations. There have been no published clinical studies to support this claim. The purpose of this research was to investigate the effects of Relacore on BMI and serum cortisol concentrations. Methods Fifteen college-aged (20-24 year old) women participated in this study. The experimental protocol was approved by the Brigham Young University Hawaii Human Subjects Committee. Prior to the start of this study, the BMI of each subject was determined and a baseline saliva sample was collected. Each subject was counseled not to alter her lifestyle (i.e. diet and exercise) during the three month test period. A repeated measures protocol was employed to evaluate the effects of Relacore on salivary cortisol. Each subject ingested the recommended dosage of four Relacore capsules daily (1622 mg); two at breakfast and two with dinner, for 90 days. Subsequent saliva samples were collected at 0700 hours on day 30, 60 and 90. Serum cortisol concentrations were measured from saliva samples by enzyme immunoassay at Salimetrics Laboratories (State College, PA) (Papanicolaou et al. 2002, Raff et al. 2003, and Van Aken et al. 2003). The BMI results were analyzed by paired T-Test, the cortisol results were analyzed by repeated measure ANOVA. 2

4 Results All fifteen participating women were between twenty and twenty four years of age with a wide range of initial BMI s and baseline cortisol concentrations (Fig. 1, Table 1). Relacore was tolerated by all subjects with no ill effects reported. No changes in diet and exercise were reported during the course of the study. The initial and final BMI of each subject was compared statically using a paired t- test. There were no significant changes in BMI as a result of Relacore supplementation (p=0.11) (Fig. 1). Initial and Final BMI BMI 30 Initial BMI Final BMI Subjects (p=0.12) in salivary cortisol over the course of the study (Fig. 2, Table 2). A Newman- Figure 1: The initial and final Body Mass Indices (BMI) for all test subjects over the course of the study. The results of a repeated measures ANOVA indicated no significant differences 3

5 Keuls Multiple Comparison Test confirmed that there were no significant changes in salivary cortisol at any time during the course of the study (table 3). Table 1: The BMI and salivary cortisol concentrations from all subjects in ug/dl taken at thirty day intervals. Subject Number Baseline Cortisol Concentration (ug/dl) 30 Days 60 Days 90 Days Initial BMI Final BMI Mean (± SD) 0.66 (±0.29) 0.65 (±0.30) 0.52 (±0.26) 0.63 (±0.22) 26.6 (±7.13) 26.4 (±7.35) Table 2: The Repeated Measures ANOVA for cortisol concentration. Source S.S. D.F. M.S. F P Between Subject Within Subject

6 Rep. Factor Error Total Table 3: A graphical representation of the Newman-Keuls comparisons test. At the 0.05 significance level, the means of any two groups underscored by the same line are not significantly different. Gp 1 represents initial cortisol readings, Gp 2 represents 30 day readings, Gp 3 represents 60 day readings and Gp 4 represents 90 day readings. Gp Gp Gp Gp Salivary Cortisol Levels Cortisol (ug/dl) Baseline 30 Days 60 Days 90 Days Subject Figure 2: The salivary cortisol concentrations for all subjects at every test day (initial, 30 days, 60 days, and 90 days). 5

7 Discussion Recent reports suggest that 300 million people world wide are obese and that more than 300,000 deaths a year in the United Stated are linked to obesity. The most obvious symptoms of obesity are decreases in mobility and appearance, yet obesity leads to more serious health conditions and diseases such as type 2 diabetes, hypertension, colon and breast cancer. Obesity tends to be caused by a lack of physical activity and poor nutrition (continual intake of excess calories). There is no single definition of obesity; it most commonly is referred to as a disease, yet is more accurately described as a variety of different disorders influenced by genetic, metabolic and environmental factors. In this study three of the fifteen subjects had a BMI over 30, which qualify them as obese. These individuals reported no conditions related to obesity but are candidates for a host of obesity related disorders. The other subjects were not obese but many approached the upper limits of recommended BMI according to the Center for Disease Control and Prevention. Obesity has been linked causatively to stress. As stress levels rise cortisol levels escalate leading to unwanted weight gain by increased appetite and/or cravings. Cortisol stimulates fat and carbohydrate metabolism and insulin release for blood sugar level maintenance, consequentially increasing appetite. Relacore, along with other diet-pill products such as CortiSlim, CortiDiet and CortiDrene, claim to reduce cortisol levels in the body by lowering these stress-induced amplified cortisol levels, facilitating weight loss. These claims have not been substantiated and remain a marketing ploy to encourage sales. 6

8 This study suggests that Relacore, manufactured by Klein-Becker, had no affect on BMI or salivary cortisol concentrations, Relacore was not observed to reduce cortisol concentrations and had no effect on body fat/bmi. The marketing claims made by Klein- Becker, in reference to Relacore are misleading. Additionally, cost is an important issue to consider. A three months supply for one person is approximately $200.00, for those with a limited income this amount of money is significant. Though not tested in this study, one would be skeptical of other related diet pills claiming to lower cortisol concentrations using the same formulation as Relacore. Obesity is the second most preventable health risk. Intended weight loss is best achieved with recommended diet and exercise; by making healthy and smart eating choices and maintaining an active lifestyle. Successful weight loss can only be attained when the amount of calories consumed is less than calories expended. To reduce stress, anaerobic and aerobic activities are suggested, as well as meditation, visualization and deep breathing practices. Acknowledgments I am especially grateful to Randy Day for all his guidance and insight throughout this project as well as the rest of the Biology Faculty at Brigham Young University Hawaii for their suggestions to help make this project a success. 7

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