The Fasting Study - Unraveling the Mechanistic Effects of Prolonged Fasting in Humans.

NCT03757767 | Completed

• 1 other identifier: NL-66589.081.18
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fasting; Adipose Tissue; Clinical Trial; Lipid Metabolism

Keywords

Physiology; Humans

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (4)

• Change in whole genome expression

  There are 24 hours between the measurement in the fed and the fasted state

• Post-transcriptional changes

  There are 24 hours between the measurement in the fed and the fasted state

• Changes in metabolite profiles

  There are 24 hours between the measurement in the fed and the fasted state

• Changes in protein profiles

  There are 24 hours between the measurement in the fed and the fasted state

Other Outcomes (1)

• BMI

  At baseline

Study Arms (1)

Intervention arm

EXPERIMENTAL

Fasting for 26-hours.

Other: Fasting for 26-hours

Interventions

Fasting for 26-hours OTHER

All research subjects will have to fast for 26 hours in total. All research subjects start with a standardized meal. Two hours after the standardized meal the samples in the fed state will be taken. Research participants are not allowed to eat anything after the consumption of the standardized meal until the second measurements on day 2, 26-hours later. There are 24 hours between the two measurement points.

Also known as: Prolonged fasting

Intervention arm

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wageningen University: lead

Study Sites (1)

Wageningen University, Division of Human Nutrition

Wageningen, Gelderland, 6700 EV, Netherlands

Location

Related Publications (1)

• Ruppert PMM, Michielsen CCJR, Hazebroek EJ, Pirayesh A, Olivecrona G, Afman LA, Kersten S. Fasting induces ANGPTL4 and reduces LPL activity in human adipose tissue. Mol Metab. 2020 Oct;40:101033. doi: 10.1016/j.molmet.2020.101033. Epub 2020 Jun 3.

  PMID: 32504883 DERIVED

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Lydia Afman, PhD

  Wageningen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Research subjects are measured in the fed state and in the prolonged fasted state.

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: November 29, 2018
• Study Start: November 12, 2018
• Primary Completion: January 22, 2019
• Study Completion: January 22, 2019
• Last Updated: April 24, 2019

Record last verified: 2019-04

Locations

NL (1)