Pterostilbene - Science - Dosage
In 2005, the FDA issued a formal Guidance for Industry titled, “Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers” 1 In this document it was stated that in order to translate doses used in animal studies to human equivalent doses one must normalize the conversion by incorporating body surface area (BSA) into the equation. This is accomplished by determining the body surface area and weight of the animal used in the experiment (rat, mouse, hamster, etc). A correction factor (Km) is then determined by dividing the animal’s body weight by its BSA. The ratio of the animal’s Km factor to the human’s Km factor is then used to translate the dose2. Simply put,
The Km factor for each animal is different. Below is the average Km factor of several common laboratory animals:
From “Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. (2002) Estimating the safe starting dose in clinical trials for therapeutics in adult healthy volunteers, U.S. Food and Drug Administration, Rockville, Maryland, USA”.
Each health benefit will have an optimum daily amount of pterostilbene based on the animal studies already published.
Hamster: 2.5 mg/kg = 0.337 mg/kg for humans
=24.6 mg/day for a 160 pound person
Rat: 10-40 mg/kg = 1.62 - 6.48 mg/kg for humans
=117.8 - 471.3 mg for a 160 pound person
Rat: 2.5 - 10 mg/kg = 0.41 - 1.62 mg/kg for humans
= 29.8 - 117.8 mg for a 160 pound person
Rat: 40mg/kg = 6.48 mg/kg for humans
=471.3 mg for a 160 pound person
Mouse : 30, 300, 3000 mg/kg/day = 2.43, 24.3, 243 mg/kg/day for humans
=176.7, 1767, 17670 mg/day for a 160 pound person
Based on all of the published animal studies, the recommended daily amount of pterostilbene is 50 - 150mg/day, depending on the targeted health benefit.
- Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. (2002) Estimating the safe starting dose in clinical trials for therapeutics in adult healthy volunteers, U.S. Food and Drug Administration, Rockville, Maryland, USA.
- Dose translation from animal to human studies revisited. S Reagan-Shaw et al.; FASEB J. 22, 659 (2008)
- Pterostilbene, a new agonist for the peroxisome proliferator-activated receptor-alpha isoform, lowers plasma lipoproteins and cholesterol in hypercholesterolemic hamsters: A.M. Rimando et al.; J Agric Food Chem. 53, 3403 (2005)
- Effect of pterostilbene on hepatic key enzymes of glucose metabolism in streptozotocin- and nicotinamide-induced diabetic rats: L. Pari & M.A. Satheesh; Life Sci. 79, 641 (2006)
- Cellular and behavioral effects of stilbene resveratrol analogues: implications for reducing the deleterious effects of aging: J. Joseph et al.; J Agric Food Chem. 56, 10544 (2008)
- Dietary intake of pterostilbene, a constituent of blueberries, inhibits the β-catenin/p65 downstream signaling pathway and colon carcinogenesis in rats: S. Paul et al.; Carcinogenesis. 31, 1272 (2010)
- Dietary administration of high doses of pterostilbene and quercetin to mice is not toxic: M.J. Ruiz et al.; J Agric Food Chem.57, 3180 (2009)