Alka-Myte® Safety Study

A. Generally Regarded As Safe (GRAS) Status: January 25, 2003

The composition is made from ingredients the Food and Drug Administration (FDA) classifies as Generally Regarded as Safe (GRAS) and the FDA has written two letters confirming that fact.

B. Long-Term Use

Alka-Myte® is the active agent in pHast Legs products. There has been over 10 years’ use of Alka-Myte® in food and neutraceutical products with no serious side effects noted. A few people did experience bloating especially if the tablet was taken with a heavy meal. This issue did not occur with granule usage. In a two-year study of 15 daily users, one person dropped out very early due to a self-perceived gastrointestinal issue.

C. Cytotoxicity: June 14, 2004

Cytotoxicty Test Results for Alka-Myte® Granules with Cultured Mouse Fiberblast Cells

The test article, Alka-Myte® Granules (Tamer Labs, Seattle, WA) “is considered non-toxic under the test conditions employed.”

The purpose of the study was to evaluate the ability of the test article to elicit a cytotoxic response in cultured mouse fibroblast cells. This assay employed L-929 cells. Hence, the reason the test is technically called the “MEM Endpoint Dilution Using L-929 Mouse Fibroblast Cells” assay.

Alex Schauss, PhD, FACN
President and CEO
AIBMR Life Sciences, Inc.
4117 S. Meridian
Puyallup, WA 98373
www.aibmr.com

D. Oral Toxicity: June 22, 2005

Acute Oral Toxicity of a Nutraceutical (a.k.a. Alka-Myte® Granules) in Male and Female Sprague-Dawley Rats; Final Report

Author:
Janice Schindler-Horvat, B.S. (Study Director)
Toufan Parman, Ph.D. (Toxicologist)

Testing Facility:
SRI International
BioSciences Division
333 Ravenswood Avenue
Menlo Park, CA 94025

SRI Study No.: M384-05
SRI Project No.: P16598

Experimental Work Performed:
Start June 8, 2005
Finish June 22, 2005

SUMMARY OF STUDY:

The objective of this study was to determine the maximum tolerated dose of a nutraceutical (Alka-Myte® Granules) in male and female Sprague-Dawley rats after a single oral dose administration. Clinical observations were recorded 2-5 hours post-dose and once daily thereafter. Individual animal body weights were measured for each treatment group on Day 1 prior to dosing, Day 8 and Day 15 prior to necropsy of the animals. Gross necropsy was performed on all animals on Day 15.

All animals survived until the end of the study and had no adverse clinical signs or effects on body weight at any time during the study. Necropsy of all animals at the end of the study (Day 15) revealed gross pathologic findings in four females in the 2 g/kg treatment group which were considered unrelated to treatment with the test article. No grossly observable abnormalities occurred in any of the other animals in the study, including those in the highest dose group (5 g/Kg). In conclusion, the No Observable Adverse Effect Level (NOAEL) of Neutraceutical (Alka-Myte® Granules) administered in a single oral dose was 5 g/Kg, based on the parameters evaluated, and the maximum tolerated single oral dose is greater than 5 g/Kg.

CONTENTS:

APPROVAL SIGNATURES
SUMMARY
I. PURPOSE AND OBJECTIVE OF STUDY
II. MATERIALS AND METHODS
III. RESULTS
A. Clinical Observations
B. Body Weights
C. Necropsy
IV. DISCUSSION AND CONCLUSIONS

APPENDICES:

A. PROTOCOL B. INDIVIDUAL ANIMAL CLINICAL OBSERVATIONS
C. BODY WEIGHTS
C-1: INDIVIDUAL ANIMAL BODY WEIGHTS
C-2: SUMMARY OF BODY WEIGHTS AND WEIGHT CHANGES BY GROUP
C-3: INDIVIDUAL BODY WEIGHT CHANGES
C-4: STATISTICAL ANALYSIS OF BODY WEIGHTS BY GROUP
C-5: STATISTICAL ANALYSIS OF BODY WEIGHT CHANGES BY GROUP

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