TY - JOUR
T1 - The influence of diet upon liver function tests and serum lipids in healthy male volunteers resident in a Phase I unit
AU - Purkins, L
AU - Love, ER
AU - Eve, MD
AU - Wooldridge, CL
AU - Cowan, C
AU - Smart, TS
AU - Johnson, Philip
AU - Rapeport, WG
PY - 2004/1/1
Y1 - 2004/1/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=1242351714&partnerID=8YFLogxK
U2 - 10.1046/j.1365-2125.2003.01969.x
DO - 10.1046/j.1365-2125.2003.01969.x
M3 - Article
C2 - 14748819
SN - 1365-2125
VL - 57
SP - 199
EP - 208
JO - British Journal of Clinical Pharmacology
JF - British Journal of Clinical Pharmacology
ER -