Glutamate-Industry-Sponsored Human Studies

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TABLE 1* Glutamate-Industry-Sponsored Human Studies: Subject Selection and Methodology Favoring Production of Negative Results
Authors	Funding sources	Bias toward selecting subjects who might not be sensitive to monosodium glutamate	Bias toward reducing the likelihood that subjects would react to monosodium glutamate test material	Use of toxic or allergenic material in placebos	Use of too few subjects	Focus on variables irrelevant to production of adverse reactions
xxxxxxxxxxxxx	xxxxxx	xxxxxxxxx	xxxxxxx	xxxxxxxxx	xxxx	xxxxxxxxxxxxx
Altman DR, Fitzgerald T, Chiaramote LT. (1994)	Allerx IGTC	Stipend given no other information provided	Not all reactions were recorded no other information	3 different doses in a liquid vehicle IGTC placebos contained aspartame at the time
Bazzano G, D’Elia JA, Olson RE. (1970)	Public Health Service	Adult males no other information provided	Not all reactions were recorded no other information	Amino acid formula with glutamate as a basic diet	11	Neurologic function; Hepatic function; Serum cholesterol; Weight
Fernstrom JD, Cameron JL, Fernstrom M, McConaha C, Weltzin TE, Kaye WH. (1996)	IGTC NIH	Well subjects Informed consent		Beverage¹ IGTC placebos contained aspartame at the time.	8	Plasma glutamate; Change in plasma glutamate; Pituitary hormone secretion.
Geha RS, Beiser A, Ren C, Patterson R, Greenberger PA, Grammer LC, Ditto AM, Harris KE, Shaughnessy MA, Yarnold PR, Corren J, Saxon A. (2000)	IGTC	Stipend given Informed consent	Used capsules Not all reactions were recorded Observation time was inadequate	Part 1: ”Citrus- flavored beverage.”² Part 2: Capsules containing sucrose IGTC placebos contained aspartame at the time the study was initiated.		Reproducible response;³ Pulse; Blood pressure; Respiratory rate; Relative risk
Germano P, Cohen SG, Hahn B, Metcalfe DD. (1991)	no information given	13 non-asthmatic and 30 asthmatic adults	Not all reactions were recorded Used capsules	no information provided IGTC placebos contained aspartame at the time	13+30 1
Germano P, Cohen SG, Hibbard V, Metcalfe DD. (1993)	no information given	21 adults with a history of asthma	Not all reactions were recorded Used capsules	no information provided IGTC placebos contained aspartame at the time.	21 10	.
Goldschmiedt M, Redfern JS, Feldman M. (1990)	Ajinomoto; NIH; ILSI; VA	Well subjects Informed consent		180 mL warm beef consommé soup supplied by Ajinomoto Co., Inc. Tokyo	17 15	variables were relevant to the study done, but irrelevant to adverse reactions to MSG
Kenney RA. (1979) Part 1.	IGTC (with thanks to NESTEC)	Well subjects Informed consent	Test material was given with carbohydrates Not all reactions were recorded Observation time was inadequate	Tomato juice with common salt.	51 16
Kenney RA. (1979) Part 2.	IGTC	Informed consent	Observation time was inadequate	Sucrose; citric acid; trisodium-citrate; lemon flavor; caramel color; naringin.	57 16
Kenney, RA. (1986)	IGTC	no information provided	Not all reactions were recorded	“...soft-drink solution....” IGTC placebos contained aspartame at the time.	6	Objective parameters (routine chemical analyses)
Kerr GR, Wu-Lee M, El-Lozy M, McGandy R, Stare FJ. (1979)	Ajinomoto USA	Randomly drawn stratified random sample	Not all reactions were recorded Observation time was inadequate	Questionnaire survey
Morselli P, Garattini S. (1970)	COFAG (IGTC Europe)	Well subjects	Test material was given with carbohydrates Observation time was inadequate	Beef broth (ingredients not specified) followed by meat, vegetables, and fruit	24	Blood pressure; Pulse; Respiration rate
Prawirohardjono W, Dwiprahasto I, Astuti I, Hadiwandowo S, Kristin E, Muhammad M, Kelly MF. (2000)	IGTC	Well subjects Stipend given Informed consent	Small amounts of test material were given with carbohydrates Used capsules	Lactose in gelatin capsules	52	Blood pressure; Pulse; Respiratory rate
Rosenblum L, Bradley J, Coulston F. (1971)	no information given	Males only Informed consent	Not all reactions were recorded Observation time was inadequate	Diluted chicken stock or diluted chicken stock with sodium (ingredients not specified)	95
Schwartzstein RM, Kelleher M, Weinberger WE, Weiss JW, Drazen JM. (1987)	IGTC	Asthmatics	No all reactions were recorded Used capsules Medication not given for 12 hours prior to testing	Gelatin capsule containing sodium chloride	12
Stegink LD, Filer J, Baker GL, Bell EF. (1986)	IGTC	Informed consent from parent no other information given	Test material was given with carbohydrates	Beef consommé supplied by Ajinomoto Co., Tokyo, Japan	8	Plasma glutamate; Plasma aspartate
Stevenson DD, Simon RA, Woessner KM. (1997)	IGTC	10 alleged CRS-asthmatics and 30 alleged non-CRS asthmatics Subjects eliminated	Not all reactions were recorded	no information given IGTC placebos contained aspartame at the time.	10+30
Tanphaichitr V, Srianujata S, Pothisiri P, Sammasut R, Kulapongese S. (1983)	IGTC	Well subjects	Not all reactions were recorded Test material was given with carbohydrates	Four full days’ menus all different, without added monosodium glutamate: this food being able to mask the addition of monosodium glutamate	50	Plasma glutamate; Pleasantness or unpleasantness of food
Tanphaichitr V, Srianujata S, Leelahabul P, Kulapongse S, Patchimasiri S, Pothisiri P. (1985)	IGTC	Well subjects	Not all reactions were recorded Test material was given with carbohydrates	A full days menu without added monosodium glutamate	12
Tarasoff L, Kelly MF. (1993)	IGTC	Well subjects Stipend given Informed consent	Used capsules Test material was given with carbohydrates Not all reaction were recorded Observation time was inadequate	Both beverage and capsules: Beverage specified as containing aspartame;⁴prepared from powders supplied by the IGTC Placebos in gelatin capsules		After-taste; Intensity
Wilkin JK (1986)	VA	Well subjects	Not all reactions were recorded	no placebo	6
Woessner KM, Simon RA, Stevenson DD (1999)	IGTC; Scripps Clinic, Green Hospital & Research Institute	30 asthmatics with alleged CRS asthma and 70 without Informed consent Subjects eliminated	Not all reactions were recorded Test material was given with carbohydrates Continued medications	5 gelatin capsules containing sucrose IGTC placebos contained aspartame at the time	30+70 30
Yang WH, Drouin MA, Herbert M, Mao Y. (1997)	IGTC	Well subjects (except subjects with symptoms of CRS were accepted) Stipend given Informed consent	Not all reactions were recorded Two or more reactions were required to be counted as a reaction Observation time was inadequate	Strongly citrus tasting beverage containing sucrose supplied by the IGTC IGTC placebos contained aspartame at the time .	61 36
Zanda G, Franciosi P, Tognoin G, Risso M, Standen SM, Morselli PL, Garattini S. (1973)	no information given	Well subjects	Not all reactions were recorded Observation time was inadequate Small amounts of test material were given with carbohydrates	Beef bouillon (ingredients not specified)	72	Blood pressure; Pulse rate

*Compiled May 1, 2009
Adrienne Samuels, Ph.D.

LEGEND

FUNDING SOURCES:

COFAG: IGTC Europe

IGTC: International Glutamate Technical Committee (includes manufacturers and users of monosodium glutamate)

ILSI: International Life Sciences Institute (often under contract to the glutamate industry)

IMC: International Minerals and Chemical Corporation

NIH: National Institutes of Health

VA: Veterans Administration

BIAS IN SELECTING SUBJECTS (Not all people are sensitive to monosodium glutamate at levels ordinarily found in food.)

CRS: Chinese Restaurant Syndrome: a limited number of mild and transitory reactions reported in 1968 as being caused by ingestion of monosodium glutamate

INFORMED CONSENT, while ethically appropriate, and required of all experiments using human subjects, biases these studies.

MALES have been reputed to be less sensitive to MSG than females

STIPENDS were given to those who claimed to be sensitive to MSG

SUBJECTS were ELIMINATED prior to the study for responding to placebos that were going to be used in the study.

WELL SUBJECTS would be persons who had never experienced any of the reactions alleged to be attributable to use of monosodium glutamate (irritable bowel, migraine headache, asthma, skin rash, heart irregularities, mood swings, and depression being possibilities, for example).

BIAS TOWARD REDUCING THE LIKELIHOOD THAT SUBJECTS WOULD REACT TO MONOSODIUM GLUTAMATE TEST MATERIAL

CAPSULES guarantee slow release and, therefore, less effect of the material they contain

TEST MATERIAL GIVEN WITH CARBOHYDRATES interferes with the uptake of the test material

PLACEBOS

It would appear that in most, if not all, glutamate-industry-sponsored studies, both test and placebo material were supplied by the IGTC. According to a 1991 letter from IGTC chairman Andrew G. Ebert to LSRO-FASEB and the FDA, a “beverage mix designed to mask the taste of [monosodium glutamate]”, was modified in 1978 to replace the [former use of] sucrose with the low calorie sweetener Aspartame. Prior to the time that Northwestern University was alerted to the fact that aspartame was being used in placebo material being used in an IGTC-sponsored study being carried out by Geha et al. at Northwestern, Harvard, and UCLA, the use of aspartame in placebos was not acknowledged in research reports.

(1) BEVERAGE: Citric acid, trisodium citrate, lemon flavoring, caramel coloring, naringenin-7-rhamnosidio-glycoside (grapefruit bitter principle), sodium saccharin; prepared by Ajinomoto

(2) CITRUS-FLAVORED BEVERAGE: Sodium citrate, citric acid, saccharin, citrus flavor, and naringin were cited as ingredients. Aspartame was used (but not named) with the other ingredients prior to objections filed with Northwestern University by the Truth in Labeling Campaign.

(4) BEVERAGE: Sodium citrate dihydrate, citric acid monohydrate, potassium chloride, naringin, grapefruit flavour, caramel, and aspartame.

IRRELEVANT VARIABLES

(3) REPRODUCIBLE RESPONSE: Repetition of the same two or more responses to monosodium glutamate on two occasions, and no response to the “placebo” (which contained aspartame).

REFERENCES

Altman DR, Fitzgerald T, Chiaramonte LT. Double-blind placebo-controlled challenge (DBPCC) of persons reporting adverse reactions to monosodium glutamate (MSG). J Allergy Clin Immunol. 1994;93:303 (Abstract 844).

Bazzano G, D’Elia JA, Olson RE. Monosodium glutamate: feeding of large amounts in man and gerbils. Science. 1970;169:1208-1209.

Fernstrom JD, Cameron JL, Fernstrom MH, McConaha C, Weltzin TE, Kaye WH. Short-term neuroendocrine effects of a large, oral dose of monosodium glutamate in fasting male subjects. J Clin Endocrinol Metab. 1996;81:184-191.

Geha R, Beiser A, Ren C, et al. Multicenter multiphase double blind placebo controlled study to evaluate alleged reactions to monosodium glutamate (MSG). J Allergy Clin Immunol. 2000;106:973-980.

Germano P, Cohen SG, Hahn B, Metcalfe DD. An evaluation of clinical reactions to monosodium glutamate (MSG) in asthmatics using a blinded, placebo-controlled challenge. J Allergy Clin Immunol. 1991;87:177 (Abstract 155).

Germano P, Cohen SG, Hibbard V, Metcalfe DD. Assessment of bronchial hyperactivity by methacholine challenge (MTC) in asthmatics before and after monosodium glutamate (MSG) administration. J Allergy Clin Immunol. 1993;91:340 (Abstract 798).

Goldschmiedt M, Redfern JS, Feldman M. Food coloring and monosodium glutamate: effects on the cephalic phase of gastric acid secretion and gastrin release in humans. Am J Clin Nutr. 1990;51:794-797.

Kenney RA. Placebo-controlled studies of human reaction to oral monosodium L-glutamate. In Filer LJ Jr, Garattini S. Kare MR, Reynolds WA, Wurtman RJ, eds. Glutamic acid: advances in biochemistry and physiology. New York: Raven; 1979:363-373.

Kenney RA. The Chinese restaurant syndrome: an anecdote revisited. Food Chem Toxicol. 1986;24:351-354.

Kerr GR, Wu-Lee M, El-Lozy M, McGandy R, Stare FJ. Prevalence of the "Chinese restaurant syndrome." J Am Diet Assoc. 1979;75:29-33.

Morselli P, Garattini S. Monosodium-glutamate and the Chinese restaurant syndrome. Nature. 1970;227:611-612.

Prawirohardjono W, Dwiprahasto I, Astuti I, et al. The administration to Indonesians of monosodium L-glutamate in Indonesian foods; an assessment of adverse reactions in a randomized double-blind, crossover, placebo-controlled study. J Nutr. 2000;130:1074S-1076S.

Rosenblum L, Bradley J, Coulston F. Single and double blind studies with oral monosodium glutamate in man. Toxicol Appl Pharmacol 1971;18:367-373.

Schwartzstein RM, Kelleher M, Weinberger WE, Weiss JW, Drazen JM. Airway effect of monosodium glutamate in subjects with chronic stable asthma. J Asthma. 1987;24:167-172

Stegink LD, Filer J, Baker GL, Bell EF. Plasma glutamate concentrations in 1-year-old infants and adults ingesting monosodium L-glutamate in consommé. Pediatr Res. 1986;20:53-58.

Stevenson DD, Simon RA, Woessner KM. The role of monosodium L-glutamate (MSG) in asthma: does it exist? J Allergy Clin Immunol. 1997;99:S411 (Abstract 1670).

Tanphaichitr V, Srianujata S, Pothisiri P, Sammasut R, Kulapongese S. Postprandial responses to Thai foods with and without added monosodium L-glutamate. Nutr Rep Int. 1983;28:783-792.

Tanphaichitr V, Srianujata S, Leelahabul P, Kulapongse S, Patchimasiri S, Pothisiri P. Effect of monosodium L-glutamate in take on protein-calorie status in healthy Thai adults. Nutr Rep Int. 1985;32:1073-1080.

Tarasoff L, Kelly MF. Monosodium L-glutamate: a double-blind study and review. Food Chem Toxic. 1993;31:1019-1035.

Wilkin JK. Does monosodium glutamate cause flushing (or merely “glutamania”)? J Am Acad Dermatol. 1986;15:225-230.

Woessner KM, Simon RA, Stevenson DD. Monosodium glutamate sensitivity in asthma. J Allergy Clin Immunol. 1999;104:305-310.

Yang WH, Drouin MA, Herbert M, Mao Y. The monosodium glutamate symptom complex: assessment in a double-blind, placebo-controlled, randomized study. J Allergy Clin Immunol. 1997;99:757-762.

Zanda G, Franciosi P, Tognoin G, et al. A double blind study on the effects of monosodium glutamate in man. Biomedicine. 1973;19:202-204.

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