Effect of diet on markers of liver injury in healthy individuals Digestive System
Conditions
Interventions
Each healthy volunteer received three different diets in one of four possible sequences (randomized 1:1:1:1 using a computer generated randomization schedule) each for 8 days, which was expected to be
Sponsors
Pfizer (United States)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18-55 years old 2. No clinically relevant abnormalities identified by the medical screening 3. Body mass index (BMI) of 17.5-30.5 kg/m² 4. Total body weight >50 kg 5. Smoked =5 cigarettes daily 6. Free from the use of prescription or non-prescription drugs/dietary supplements for at least seven days or five half-lives prior to the first study period
Exclusion criteria
Exclusion criteria: 1. Women of childbearing potential 2. History of regular alcohol consumption (>7 drinks/week [female] or >14 drinks/week [male] within six months of screening 3. Treatment with an investigational drug within 30 days or fice half-lives of the first study period 4. Blood pressure =140 mm Hg (systolic) or =90 mm Hg (diastolic) following at least five minutes supine rest 5. Consumption of alcohol, caffeine, and the use of nicotine-containing products were not permitted 24-hours prior to, and during, the resident periods of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Hepatocellular injury biomarkers: ALT, AST, and glutamate dehydrogenase (GLDH) measured using blood test at baseline and Day 2, Day 3, Day 5, Day 8, Day 9 and Day 10 2. Hepatobiliary injury biomarkers: ALP and gamma-glutamyl transferase (GGT) measured using blood test at baseline and Day 2, Day 3, Day 5, Day 8, Day 9 and Day 10 3. Hepatic function biomarkers: 3.1. Total bilirubin measured using blood test at baseline and Day 2, Day 3, Day 5, Day 8, Day 9 and Day10 3.2. Fasting total bile acids using blood test at baseline and Day 2 with hourly measurement from Hour 1 to Hour 16, Day 2, Day 3, Day 5, Day 8 with hourly measurement from Hour 1 to Hour 16, Day 9 with hourly measurements from Hour 1 to Hour 16, Day 10 4. Total bile acids during the post-meal period (8am-1pm, 1pm-6pm, 6pm-8am) measured using blood test at Day 9 during the post-meal period (from Hour 1 to Hour 6, Hour 6 to Hour 10, hour 10 to hour 24 5. Concentration of novel biomarkers (GLDH, micro RNA) measured using blood test at baseline and D2, Day 3, Day 5, Day 8, Day 9 and Day 10. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglyceride measured using blood test at baseline and Day 2, Day 3, Day 5, Day 8, Day 9 and Day 10 2. Total bile acids and triglycerides at baseline and hourly from 8 am - 1 pm on Day 8 (fed) and Day 9 (fasted) measured using a blood test 3. Concentrations of bilirubin, ALT, AST, GGT, ALP, total cholesterol, LDL, HDL, triglycerides, and creatine kinase (CK) measured using blood test at baseline and diet on Day 9 and Day 9 with fasting | — |
Countries
United States of America
Outcome results
None listed