TEST ARTICLE TEST PERFORMED PERFORMING LABORATORY SAMPLES SUBMITTED RESULT
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1 Close To Nature Facility I Facility II Kanaya Kawara. Haibara-Gun. Kanaya, Shizuoka Japan. Phone: Fax: Takaoka Higashi 101 Hamamatsu, Shizuoka Japan Phone: Fax: SPONSOR REPORT NUMBER Nurman Salim Kenrico LTD Kanaya Kawara. Haibara-Gun. Kanaya, Shizuoka Nurma n Salim Digitally signed by Nurman Salim DN: cn=nurman Salim, c=jp, l=kanaya, st=shizuoka, o=kenrico LTD, =kenrico@kenrico.com Date: :12:52 +09'00' RTL REPORT DATE TEST ARTICLE Kenrico Sap Sheet TEST PERFORMED CLINICAL TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF A NUTRACEUTICAL FOR LOWERING LDL-CHOLESTEROL LEVELS AND TRIGLYCERIDES PERFORMING LABORATORY Research Testing Laboratories, Inc. 127 Old Cutter Mill Road Great Neck, NY SAMPLES SUBMITTED March 14, 2006 RESULT Result of clinical trial shows evidence of reduced LDL-Cholesterol levels and Triglycerides in 2 weeks of application. May 30, 2006
2 Kenrico LTD RTL Page: 2 of 6 TEST PRODUCTS AND DOSAGES Test Products A new formulation of botanically-based alternative medicinal product (detox pads) made from natural substances. The size of the detox pad is approximately 6 x 8 cm, and the size of the tape is approximately 10 x 12 cm. Test Product Dosages and Administration Subjects were instructed to wear four detox pads per day (two detox pads [one on the middle of the bottom of each foot] for 7-9 hours during the day, and two detox pads [one on the middle of the bottom of each foot] 7-9 hours during sleep at night). All test products used in the study were kept at the investigational site under secure, temperature- and humidity- monitored conditions. SUBJECTS Males and females, between 18 and 65 years of age, balanced for BMI ( , and ), were enrolled in the study. PROCEDURES Potential subjects reported to the study site, having fested, read and signed informed consent documents and HIPAA authorization forms. Vital signs (blood pressure, heart rate, and body temperature) were measured and recorded. Body weight and height were measured, and BMI was calculated. A ten to twelve-hour fasting blood sample was drawn (2 tubes [totaling 20 mls] of blood were drawn for CBC, Chemistry Profile [including TC, LDL-c, and HDL-c] measurements). STUDY MANAGEMENT Institutional Review Board (IRB) Before initiation of this study, the protocol, informed consent, and test product(s) product information were submitted for review and approval of a duly constituted IRB. Test Product Storage and Records
3 Kenrico LTD RTL Page: 3 of 6 The test product(s) were stored in a secure area. Dispensation of the test product(s) was conducted under the supervision of the Investigator, or his/her qualified designee. A detailed test product(s) dispensation log was maintained. Unused test product was returned to the sponsor or destroyed at the sponsor s discretion. Monitoring Representatives of the sponsor may visit and monitor the activities of this study at the investigational site. SCHEDULE OF EVENTS Informed Consent/HIPAA Authorization Study Eligibility Medical History Assess Concomitant Medications Vital Signs (blood pressure, heart rate, body temperature) Weight Measured Height Measured BMI Calculated Physical Assessment of the Bottoms of Both Feet Fasting Blood Draws for CBC, Chemistry Profile Measurements Review Continuation Criteria Study Products Dispensed for Use Study Products Collected Subject Diaries Dispensed Subject Diaries Collected and Reviewed Subject Questionnaire Completed Safety Assessment/Adverse Events/Intercurrent Illnesses SUMMARY OF RESULTS Evidence of reduced LDL-Cholesterol Levels and Triglycerides.
4 Kenrico LTD RTL Page: 4 of 6 LOW DENSITY LIPOPROTEIN (LDL) CHOLESTEROL Low-density lipoprotein (LDL) carries cholesterol in the blood and around the body, for use by cells. It is commonly referred to as "bad cholesterol" due to the link between high LDL levels and cardiovascular disease. TRIGLYCERIDES Excess triglycerides is linked to the occurrence of coronary artery disease in some people. Elevated triglycerides may be a consequence of other disease, such as untreated diabetes mellitus. Like cholesterol, increases in triglyceride levels can be detected by plasma measurements. These measurements should be made after an overnight fast. ANALYSIS OF CLINICAL DATA Patient name: DLA, 8635 Patient ID: (08635) DOB:12/14/60 SEX: F LDL CHOLESTEROL COLLECTED ON RESULT REF 03/15/ /29/ * 22 decrement within 2 weeks. TRIGLYCERIDES COLLECTED ON RESULT REF 03/15/ /29/ * 37 decrement within 2 weeks.
5 Kenrico LTD RTL Page: 5 of 6 Patient name: KMH, 8635 Patient ID: (08635) DOB:06/26/58 SEX: M LDL CHOLESTEROL COLLECTED ON RESULT REF 03/15/ /29/ * 5 decrement within 2 weeks. TRIGLYCERIDES COLLECTED ON RESULT REF 03/15/ /29/ * 12 decrement within 2 weeks. Patient name: W, W Patient ID: (08635) DOB:03/11/57 SEX: M LDL CHOLESTEROL COLLECTED ON RESULT REF 03/15/ /29/ * 35 decrement within 2 weeks. TRIGLYCERIDES COLLECTED ON RESULT REF 03/15/ /29/ * 19 decrement within 2 weeks.
6 Kenrico LTD RTL Page: 6 of 6 The information contained in this document is the property of Kenrico LTD and is therefore provided to you in confidence for review by you or your reviewing committee. It is understood that this information will not be disclosed to others without written authorization from Kenrico LTD. This study is in compliance with Good Clinical Practice (GCP, as defined in CPMP/ICH/135/95), the Declaration of Helsinki (with amendments) and local legal and regulatory requirements.
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