The effect of time of day, fasting and meal type on biomarkers of liver injury in healthy subjects
| ISRCTN | ISRCTN15174994 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15174994 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | A9001500 |
| Sponsor | Pfizer (United States) |
| Funder | Pfizer |
- Submission date
- 13/03/2021
- Registration date
- 06/04/2021
- Last edited
- 06/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
When new drugs are given to patients, it is important to monitor liver function and liver injury in case the new drug affect liver health. However, the food that patients eat can also influence liver function. Therefore, this study aimed to determine how diet alone can affect liver function.
Who can participate?
Healthy volunteers between the ages of 18-55 years could participate.
What does the study involve?
There were three phases of the study. In each phase, participants randomly received one of four possible diets for eight days (1) standard diet, (2) standard high-calorie diet, (3) high-fat high-calorie diet, and (4) high carbohydrate high-calorie diet. Participants then returned to their normal diets for 11 days before being randomized to a different diet for another 8 days. This process was done so that each participant received three different diets. Assessments included molecular markers of liver function, liver injury, and lipids over time.
What are the possible benefits and risks of participating?
Healthy volunteers who enrolled in this study were at minimal risk for adverse events.
Where is the study run from?
Pfizer Clinical Research Unit in New Haven, CT, USA.
When is the study starting and how long is it expected to run for?
February 2017 to September 2017
Who is funding the study?
Pfizer Inc (USA)
Who is the main contact?
Sanela Tarabar, sanela.tarabar@pfizer.com
Contact information
Scientific
Pfizer
1 Portland Street
Cambridge, MA
02139
United States of America
 ORCID ID |
0000-0001-5858-1934 |
|---|---|
| Phone | +1 203 606 4546 |
| sanela.tarabar@pfizer.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open-label randomized single-centre three-period four-sequence balanced incomplete block design study |
| Secondary study design | Randomised cross over trial |
| Study type | Participant information sheet |
| Scientific title | A randomized study to assess the effect of high-calorie, high-carbohydrate, and/or high-fat diet on biomarkers of liver injury in healthy volunteers |
| Study objectives | This study aimed to determine the effect of different food type regimens on biomarkers of hepatocellular and hepatobiliary injury, as well as biomarkers of liver function and lipid profiles |
| Ethics approval(s) | Approved 01/06/2017, IntegReview Ethical Review Board (3815 S Capital of Texas Hwy, Suite #320, Austin, TX, 78704, USA; +1-512-326-3001; clientservices@integreview.com), ref: A9001500 |
| Health condition(s) or problem(s) studied | Effect of diet on markers of liver injury in healthy individuals |
| Intervention | 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 a sufficient duration to detect liver enzyme changes. The four possible diets included (1) standard diet (3000 kcal, 55% carbohydrates, 30% fat,15% protein) (2) standard high-calorie diet (4500 kcal, 55% carbohydrates, 30% fat, 15% protein) (3) high-fat high-calorie diet (4500 kcal, 25% carbohydrates, 60% fat, 15% protein) (4) high-carbohydrate high-calorie diet (4500 kcal, 65% carbohydrates, 20% fat, 15% protein) During each period, participants spent 10 days (11 nights) at the Clinical Research Unit. Meals were administered at intervals of approximately five hours, except on Day 9, when participants fasted until 1 pm. This was followed by a non-resident washout of at least 11 days, during which participants consumed their usual diet. |
| Intervention type | Other |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
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 |
| Completion date | 06/09/2017 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 55 Years |
| Sex | All |
| Target sample size at registration | 12 |
| Total final enrolment | 12 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 16/06/2017 |
| Date of final enrolment | 30/06/2017 |
Locations
Countries of recruitment
- United States of America
Study participating centre
New Haven
06511
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Upon request, and subject to certain criteria, conditions, and exceptions (see https://www.pfizer.com/science/clinical-trials/trial-data-and-results for more information), Pfizer will provide access to individual de-identified participant data from Pfizer-sponsored global interventional clinical studies conducted for medicines, vaccines, and medical devices (1) for indications that have been approved in the US and/or EU or (2) in programs that have been terminated (i.e. development for all indications has been discontinued). Pfizer will also consider requests for the protocol, data dictionary and statistical analysis pan. Data may be requested from Pfizer trials 24 months after study completion. The de-identified participant data will be made available to researchers whose proposals meet the research criteria and other conditions, and for which an exception does no apply, via a secure portal. To gain access, data requestors must enter into a data access agreement with Pfizer. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Statistical Analysis Plan | version v1.0 | 22/08/2017 | 06/04/2021 | No | No |
Additional files
- ISRCTN15174994_SAP_v1.0_22Aug2017.PDF
- uploaded 06/04/2021
Editorial Notes
06/04/2021: The statistical analysis plan was uploaded as an additional file.
15/03/2021: Trial's existence confirmed by Integ Review IRB.
