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Clinical Trial
. 2004 Feb;57(2):199-208.
doi: 10.1046/j.1365-2125.2003.01969.x.

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

L Purkins  1 , E R Love, M D Eve, C L Wooldridge, C Cowan, T S Smart, P J Johnson, W G Rapeport
Affiliations
Clinical Trial

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

L Purkins et al. Br J Clin Pharmacol. 2004 Feb.

Abstract

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.

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Figures

Figure 1
Figure 1
Effect of diet upon bilirubin. [Graphs (Figures 1–6) represent various laboratory parameters for the three diets (Standard (▾), HFHC (○) and HCHC (•)). Data points are determined from blood samples taken on days 1, 3, 5, 6, 7, 8, 9, 12 and 16 (mean ± SEM). Shaded blocks represent time spent resident at the Research Clinic. Horizontal line(s) denote upper and lower reference limits (ULN and LLN, respectively) where they fall within the scale on the ordinates.]
Figure 6
Figure 6
Effect of diet upon creatinine kinase. LLN (—), ULN (—), Standard (▾), HFHC (○) and HCHC (•).
Figure 2
Figure 2
Effect of diet upon alanine transaminase. ULN (—), Standard (▾), HFHC (○) and HCHC (•).
Figure 3
Figure 3
Effect of diet upon aspartate transaminase. ULN (—), Standard (▾), HFHC (○) and HCHC (•).
Figure 4
Figure 4
Effect of diet upon gamma glutamyl transferase. Standard (▾), HFHC (○) and HCHC (•).
Figure 5
Figure 5
Effect of diet upon triglycerides. LLN (—), ULN (—), Standard (▾), HFHC (○) and HCHC (•).
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