Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics
Online ISSN : 1882-8272
Print ISSN : 0388-1601
ISSN-L : 0388-1601
Influence of 7-day Hospitalization for Phase I Study on the Biochemical Laboratory Tests of Healthy Volunteers
Mitsutaka KANAMARUSatoru NAGASHIMAToshihiko UEMATSUMitsuyoshi NAKASHIMA
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1989 Volume 20 Issue 3 Pages 493-503

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Abstract

Influence of the imbalance between calorie intake and calorie consumption in an excess intake condition during 7-day hospitalization was studied in healthy male volunteers. Each member of one group (constrained state ; n=6: group C) kept his calorie consumption, by exercise, to less than 200 kcal/day and each member of the other group (exercise; n=6: group E) kept it to more than 500 kcal/day. The results are summarized as follows:
(1) The mean body weight of group C increased from 57.5 kg on day 1 to 58.5 kg on day 8, while that of group E increased from 62.8 to 62 .9kg.
(2) The mean daily calorie intake was calculated to be about 2, 500 kcal in both groups. On the other hand, the mean to talcalorie consumption was 1, 654.1±19.6kcal/day in group Cand2, 362, 7±79, 1kcal/day in group E. The mean calorie consumption attributable to exercise was 110.3±18.3kcal/day and 706.1±80.6kcal/day, respectively.
(3) Five subjects in group C showed the elevation of s-GOT value on day 8, but all values remained within the normal limits. The mean value of s-GOT in all subjects of group C showed a statistically significant increase on days 7 and 8 as compared with the value of day 1. The value of s-GPT of group C also el evated with time in a similar way and the values were out of the normal range in 2 out of 6 subjects on day 8. The ratio of GOT/GPT in group C decreased significantly after day 6. The values of these parameters in group E showed no significant changes.
(4) The value of ChE elevated until day 5, and decreased from day 6 in group C.In group E the same parameter lowered throughout this trial.
(5) Some serum lipids showed an elevation in group C, and showed a decrease in group E.
These results indicate that healthy volunteers under a condition of excess calories may show abnormalities of liver function test due to lipid deposit in the liver. To prevent these occurrences, the control of calorie intake and moderate calorie consumption by exercise are recommended.

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© The Japanese Society of Clinical Pharmacology and Therapeutics
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