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Dietary Supplements: A Framework for Evaluating Safety (2005)
Institute of Medicine (IOM)

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. "Appendix K: Protoype Focused Monograph: Review of Anti-Androgenic Risks of Saw Palmetto Ingestion by Women." Dietary Supplements: A Framework for Evaluating Safety. Washington, DC: The National Academies Press, 2005.

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Dietary Supplements: A Framework for Evaluating Safety

TABLE A Individual Components of Saw Palmetto Fruit

Hexane-extractable componentsa

Fatty acids – Breu et al., 1992; Cristoni et al., 1997; De Swaef and Vlietinck, 1996;

 

Hatinguais et al., 1981; Jommi et al., 1988; Kloss, 1966. No data suggestive of toxicity are available.

Valeric acid – C5:0; a possible constituent of fresh saw palmetto fruit (Kloss, 1966).

Caproic – C6:0; contributes to characteristic odor of fresh saw palmetto fruit.

Caprylic acid – C8:0; < 2% of total fatty acids; contributes to characteristic odor of fresh saw palmetto fruit.

Capric acid – C10:0; caprinic acid; < 2% of total fatty acids). In vitro: inhibited type 2 steroid 5-α-reductase in homogenates of human genital fibroblasts grown in culture (IC50 1.0 mM) (Niederprüm et al., 1995).

Lauric acid – C12:0; 24% of total fatty acids.

 

 

Lauric acid – 0.5 mg/mL ethanol extract (De Swaef and Vlietinck, 1996). In vitro: lauric acid inhibited type 2 steroid 5-α-reductase in homogenates of human genital fibroblasts grown in culture (IC50 0.2 mM). Inhibited type 1 steroid 5-α-reductase in homogenates of human prostate tissue (IC50 < 0.5 mM) (Niederprüm et al., 1995).

Ethyl laurate – 0.7 mg/mL ethanol extract (De Swaef and Vlietinck, 1996). In vitro: ethyl laurate or other esterified forms of lauric acid did not inhibit type 2 steroid 5-α-reductase.

 

Myristic acid – C14:0; 12% of total fatty acids. In vitro: inhibited type 2 steroid 5-α-reductase in homogenates of human genital fibroblasts grown in culture (IC40 0.6 mM) (Niederprüm et al., 1995).

Palmitic acid – C16:0.

Palmitoleic acid – C16:1; 9% of total fatty acids.

Stearic acid – C18:0.

Oleic acid – C18:1; 33% of total fatty acids. In vitro: inhibited type 2 steroid 5-α-reductase in homogenates of human genital fibroblasts grown in culture (IC50 0.4 mM) (Niederprüm et al., 1995).

Linoleic acid – C18:2; 4% of total fatty acids. In vitro: inhibited type 2 steroid 5-α-reductase in homogenates of human genital fibroblasts grown in culture (IC50 0.08 mM) (Niederprüm et al., 1995).

Linolenic acid – C18:3. In vitro: inhibited type 2 steroid 5-α-reductase in homogenates of human genital fibroblasts grown in culture (IC50 0.1 mM) (Niederprüm et al., 1995).

Arachidic acid – C20:0.

Most fatty acids are also present as ethyl esters. Some reviewers reported relatively small proportions as ethyl esters 1 (Nemecz, 1998); however, some investigators reported relatively large amounts (De Swaef and Vlietinck, 1996; De Swaef et al., 1996).

Phenolics – Some of these components have also been reported to be ethanol extractable. No data suggestive of toxicity are available.

 

Anthranilic acid – an aromatic amine (2-aminobenzoic acid)

Trans-ferulic acid – 3-(4-hydroxy-3-methoxyphenyl)-2-propenoic acid.

Syringaldehyde – 4-hydroxy-3,5-dimethoxy-benzaldehyde.

Vanillic acid – 4-hydroxy-3-methoxy-benzoic acid.

Page
463
Front Matter (R1-R20)
Executive Summary (1-18)
1 Introduction and Background (19-42)
2 Approaches Used by Others and Existing Safety Frameworks (43-84)
3 The Framework (85-125)
4 Categories of Scientific Evidence--Human Information and Data (126-155)
5 Categories of Scientific Evidence--Animal Data (156-174)
6 Categories of Scientific Evidence--Information About Related Substances (175-216)
7 Categories of Scientific Evidence--In Vitro Data (217-234)
8 Interactions (235-246)
9 Vulnerable Groups and Prevalance of Use (247-252)
10 Scientific Principles for Integrating and Evaluating the Available Data (253-268)
11 Applying the Framework: Case Studies Using the Prototype Safety Monographs (269-291)
12 Factors Influencing Use of the Safety Framework (292-296)
13 Findings and Recommendations (297-306)
Appendix A: Existing Frameworks or Systems for Evaluating the Safety of Other Substances (307-315)
Appendix B: Scope of Work and Comments to Initial July 2002 Framework (316-321)
Appendix C: Plant Family Information (322-355)
Appendix D: Chaparral: Prototype Monograph Summary (356-362)
Appendix E: Glucosamine: Prototype Monograph Summary (363-366)
Appendix F: Melatonin: Prototype Monograph Summary (367-371)
Appendix G: Chromium Picolinate: Prototype Monograph Summary (372-375)
Appendix H: Saw Palmetto: Prototype Monograph Summary (376-379)
Appendix I: Shark Cartilage: Prototype Monograph Summary (380-384)
Appendix J: Prototype Focused Monograph: Review of Liver-Related Risks for Chaparral (385-449)
Appendix K: Protoype Focused Monograph: Review of Anti-Androgenic Risks of Saw Palmetto Ingestion by Women (450-477)
Appendix L: Acknowledgements (478-480)
Appendix M: Biographical Sketches of Commitee Members (481-488)
Index (489-506)