The influence of diet upon liver function tests and serum lipids in healthy male volunteers resident in a Phase I unit

Aim  To investigate the effect of diet upon liver function tests and serum lipids within the restricted environment of a Phase I unit. Methods  An open randomized three‐way crossover study was designed with subjects consuming three types of diet. The diets comprised, a balanced normal calorie diet,...

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Published in:British journal of clinical pharmacology 2004-02, Vol.57 (2), p.199-208
Main Authors: Purkins, L., Love, E. R., Eve, M. D., Wooldridge, C. L., Cowan, C., Smart, T. S., Johnson, P. J., Rapeport, W. G.
Format: Article
Language:English
Subjects:
Adult
Biological and medical sciences
Cross-Over Studies
Data Interpretation in Drug Development
Diet
Fasting - blood
Human physiology applied to population studies and life conditions. Human ecophysiology
Humans
lipids
Lipids - blood
Liver Function Tests
Male
Medical sciences
Nutritional survey. Food supply and nutritional requirement
Phase I
Transaminases - blood
Triglycerides - blood
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Summary:Aim  To investigate the effect of diet upon liver function tests and serum lipids within the restricted environment of a Phase I unit. Methods  An open randomized three‐way crossover study was designed with subjects consuming three types of diet. The diets comprised, a balanced normal calorie diet, a high‐carbohydrate high‐calorie diet and a high‐fat high‐calorie diet. Each diet was consumed in a randomized sequence over 8 days with a recovery period of 14 days between periods. The blood concentrations of various laboratory parameters were measured at intervals throughout each dietary period and during the recovery periods. Results  Blood transaminase activity and triglyceride concentrations increased significantly whilst subjects consumed a high‐carbohydrate high‐calorie diet but not when fed either a high‐fat high‐calorie diet or a balanced normal calorie diet. Conclusions  The rises in transaminases and triglycerides were caused by the carbohydrate content of the diet rather than its calorific value. Sucrose rather than starch was the carbohydrate which caused the rise in transaminases and triglycerides. The importance of controlling diet in Phase I studies is stressed.
ISSN:0306-5251
1365-2125
DOI:10.1046/j.1365-2125.2003.01969.x