Randomized, double-blind, placebo-controlled, consumer rechallenge test of clean salted snacks

Regulatory Toxicology and Pharmacology

Volumn 26, Issue 2, 1997, Pages 200-209

  Zorich, Nora L ^a   Biedermann, David ^a   Riccardi, Karen A ^a   Bishop, Lori J ^a   Filloon, Thomas G ^a  

^a PROCTER AND GAMBLE COMPANY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

SUCROSE POLYESTER;

ABDOMINAL CRAMP; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DATA BASE; DIARRHEA; DOUBLE BLIND PROCEDURE; FEMALE; FLATULENCE; FOOD INTAKE; GASTROINTESTINAL SYMPTOM; HUMAN; MAJOR CLINICAL STUDY; MALE; NAUSEA; ORAL DRUG ADMINISTRATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; VOMITING;

SOLANUM TUBEROSUM;

EID: 0030732539     PISSN: 02732300     EISSN: None     Source Type: Journal    
DOI: 10.1006/rtph.1997.1164     Document Type: Article

References (26)

1. Aggarwal A. M., Camilleri M., Phillips S. F., Schlagheck T. G., Brown M. L., Thomforde G. M. Olestra, a nondigestible, nonabsorbable fat. Effects on gastrointestinal and colonic transit. Dig. Dis. Sci. 38:1993;1009-1014.
2. Bayless T. M., Rothfeld B., Massa C., Wise L., Paige D., Bedine M. S. Lactose and milk intolerance: Clinical implications. N. Engl. J. Med. 292:1975;1156-1159.
3. Bergholz C. M. Safety evaluation of olestra a nonabsorbable fat replacement derived from fat. Food Safety Assessment. ACS Symposium Series 484. 1992;American Chemical Society. p. 391-399.
4. Butchko H. H., Tschanz C., Kotsonis F. N. Postmarketing surveillance of food additives. Regul. Toxicol. Pharmacol. 20:1994;105-118.
5. L. Cheskin, R. K. Miday, N. L. Zorich, T. G. Filloon, Gastrointestinal symptoms following acute consumption of olestra or regular triglyceride potato chips: A controlled comparison, J. Am. Med. Assoc.
6. J. Am. Med. Assoc. 254:1985;400-402.
7. Crouse J. R., Grundy S. M. Effects of sucrose polyester on cholesterol metabolism in man. Metabolism. 28:1979;994-1000.
8. Eastwood M. A., Allgood G. S. The effect of olestra on breath gas production and faecal microbial counts. Eur. J. Clin. Nutr. 49:1995;627-639.
9. Fallat R. W., Glueck C. J., Lutmer R., Mattson F. H. Short term study of sucrose polyester, a nonabsorbable fat-like material, as a dietary agent for lowering plasma cholesterol. Am. J. Clin. Nutr. 29:1976;1204-1215.
10. Fed. Regist. 61:1996;3118-3173.
11. Glueck C. J., Jandacek R. J., Ravi Subbiah M. T., Gallon L., Yunker R., Allen C., Hogg E., Laskarzewski P. M. Effect of sucrose polyester on fecal bile acid excretion and composition in normal men. Am. J. Clin. Nutr. 33:1980;2177-2181.
12. Koonsvitsky B. P., Berry D. A., Jones M. B., Lin P. Y. T., Cooper D. A., Jones D. Y., Jackson J. E. Olestra affects serum concentrations of α-tocopherol and carotenoids but not vitamin D or vitamin K status in free-living subjects. J. Nutr. 127:1997;1636S-1645S.
13. Lafranconi W. M., Long P. H., Atkinson J. E., Knezevich A. L., Wooding W. L. Chronic toxicity and carcinogenicity of olestra in Swiss CD-1 mice. Food Chem. Toxicol. 32:1994;789-798.
14. Lawson K. D., Middleton S. J., Hassall C. D. Olestra, a nonabsorbed, noncaloric replacement for dietary fat. A review. Drug Metab. Rev. 29:1997;651-703.
15. Mehta C. R., Patel N. R. Exact logistic regression: Theory and examples. Stat. Med. 14:1995;2143-2160.
16. Miller D. L., Hammer V. A., Shide D. J., Peters J. C., Rolls B. J. Consumption of fat-free potato chips by obese and restrained males and females. Annu. Meeting Fed. Am. Soc. Exp. Biol. 9:1995;A190.
17. Miller K. W., Long P. H. A 91-day feeding study in rats with heated olestra/vegetable oil blends. Food Chem. Toxicol. 28:1990;307-315.
18. Miller K. W., Wood F. E., Stuard S. B., Alden C. L. A 20-month olestra feeding study in dogs. Food Chem. Toxicol. 29:1991;427-435.
19. Nuck B. A., Schlagheck T. G., Federle T. W. Inability of the human fecal microflora to metabolize the nonabsorbable fat substitute, olestra. J. Ind. Microbiol. 13:1994;328-334.
20. Schiffman S. S., Buckley C. E. III, Sampson H. A., Massey E. W., Baraniuk J. N., Follett J. V., Warwick Z. S. Aspartame and susceptibility to headache. N. Engl. J. Med. 317:1987;1181-1185.
21. Schlagheck T. G., Kesler J. M., Jones M. B., Zorich N. L., Dugan L. D., Davidson M. H., Peters J. C. Olestra's effect on vitamins D and E in humans can be offset by increasing the dietary levels of these vitamins. J. Nutr. 127:1997a;1666S-1685S.
22. Schlagheck T. G., Riccardi K. A., Zorich N. L., Torri S. A., Dugan L. D., Peters J. C. Olestra dose response on fat-soluble and water-soluble nutrients in humans. J. Nutr. 127:1997b;1646S-1665S.
23. Suarez F. L., Savaiano D. A., Levitt M. D. A comparison of symptoms after the consumption of milk or lactose-hydrolyzed milk by people with self-reported severe lactose intolerance. N. Engl. J. Med. 333:1995;1-4.
24. D. R. Webb, G. G. Harrison, M. J. Lee, M. H. Huang, Estimated consumption and eating frequency of olestra from salty snacks using menu census data, J. Nutr. 127, 1547S, 1554S.
25. Wood F. E., Tierney W. J., Knezevich A. L., Bolte H. F., Maurer J. K., Bruce R. D. Chronic toxicity and carcinogenicity studies of olestra in Fischer 344 rats. Food Chem. Toxicol. 29:1991;223-230.
26. N. L. Zorich, M. B. Jones, J. M. Kesler, S. B. Carter, M. A. Sutton, T. Bayless, A randomized, double-blind study of the effect of olestra on disease activity in patients with quiescent inflammatory bowel disease, Am. J. Med.