Fasting Clinical Trial
Official title:
The Fasting Study - Unraveling the Mechanistic Effects of Prolonged Fasting in Humans.
Verified date | April 2019 |
Source | Wageningen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Elevated levels of plasma triglycerides are increasingly recognized as an important causal risk factor for cardiovascular disease and associated pathologies. Lowering plasma triglycerides may therefore be a therapeutic target to lower cardiovascular disease risk. With this study the investigators want to examine the effects of fasting on adipose tissue metabolism in humans.
Status | Completed |
Enrollment | 24 |
Est. completion date | January 22, 2019 |
Est. primary completion date | January 22, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Apparently healthy man or woman - Age 40-70y at the time of recruitment - BMI of 22-30 kg/m2 - Willing to fast for 26 hours - Willing to give blood samples - Willing to give adipose tissue biopsies - Willing to consume the standardized meal on test day 1 - Signed informed consent - Having a general practitioner Exclusion Criteria: - Alcohol on average: more than 2 consumptions/day or more than 14 consumptions/week - Tobacco smoker - Usage of drugs - Following a diet within one month of starting the study (for example a ketogenic diet) - Allergic to one or more components of the standardized meal - Donated or intend to donate blood from 2 months before the study until the end of the study - Unstable body weight (weight gain or loss >5 kg in the past three months) - Diagnosed with any long-term medical condition that can interfere with the study outcome (i.e. cardiovascular disease, diabetes mellitus type 1 or 2, liver, pulmonary, or renal disease) - Use of prescribed medication - Use of supplements or over the counter medication (OTC) known to interfere with glucose or lipid homeostasis in the week before the start of the study, and during the study - Being pregnant or lactating - Participation in another biomedical study (other than the EetMeetWeet study) during this study - Members of the research team, or first degree family members of the research team - Working, or doing an internship at the division "Human Nutrition and Health" - Wageningen University |
Country | Name | City | State |
---|---|---|---|
Netherlands | Wageningen University, Division of Human Nutrition | Wageningen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Wageningen University |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | BMI | weight (in kg) and height (in meters) will be measured and combined to report BMI in kg/m^2 | At baseline | |
Primary | Change in ANGPTL4 protein and gene expression in adipose tissue | Using Western blotting, the change in ANGPTL4 protein expression in adipose tissue will be measured from fed to a prolonged fasted state. The change in ANGPTL4 gene expression in adipose tissue will be measured from fed to a prolonged fasted state using whole genome affymetrix microarrays and targeted quantitative real time PCR. | there are 24 hours between the measurement in de fed and the fasted state | |
Primary | Change in LPL expression, both gene and protein, and LPL activity in adipose tissue | Using Western blotting, the change in LPL protein expression in adipose tissue will be measured from fed to a prolonged fasted state. The change in LPL gene expression in adipose tissue will be measured from fed to a prolonged fasted state using whole genome affymetrix microarrays and targeted quantitative real time PCR. The change in LPL activity in subcutaneous adipose tissue will be measured from fed to a prolonged fasted state, using a lipoprotein lipase assay. | There are 24 hours between the measurement in the fed and the fasted state | |
Primary | Change in ANGPTL4 expression in plasma | Using ELISA, the change in ANGPTL4 expression in plasma will be measured from fed to a prolonged fasted state. | There are 24 hours between the measurement in the fed and the fasted state | |
Primary | Change in ANGPTL4 and LPL gene expression in PBMCs | The change in ANGPTL4 and LPL gene expression in PBMCs from fed to a prolonged fasted state will be measured using whole genome affymetrix microarrays and targeted quantitative real time PCR. | There are 24 hours between the measurement in the fed and the fasted state | |
Secondary | Change in whole genome expression | Using whole genome affymetrix micorarrays, the change in whole genome gene expression in both adipose tissue and PBMCs will be measured from fed to a prolonged fasted state. | There are 24 hours between the measurement in the fed and the fasted state | |
Secondary | Post-transcriptional changes | Using microRNAarrays of Thermo Fisher Scientific, targeted digital droplet PCR, and quantitative real time PCR, post-transcriptional changes in adipose tissue and PBMCs will be measured from fed to a prolonged fasted state. | There are 24 hours between the measurement in the fed and the fasted state | |
Secondary | Changes in metabolite profiles | Using untargeted and targeted metabolomic platforms, the changes in metabolite profiles in the adipose tissue and plasma/serum will be measured. | There are 24 hours between the measurement in the fed and the fasted state | |
Secondary | Changes in protein profiles | Using untargeted and targeted proteomic platforms, the changes in protein profiles in the adipose tissue and plasma/serum will be measured. | There are 24 hours between the measurement in the fed and the fasted state |
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