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Time Course and Nature of Nutrient Sensing During Fasting in Humans

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ClinicalTrials.gov Identifier: NCT01387919
Recruitment Status : Completed
First Posted : July 6, 2011
Last Update Posted : July 11, 2011
Centre for Medical Systems Biology
Information provided by:
Leiden University Medical Center

Brief Summary:
Several studies have begun to determine the time course of events sensing energy availability in rodents. In contrast, there is not a single study that has examined this in humans to date. A better understanding of this energy sensing machinery in humans is of utmost importance to give us new insights into developing new therapies for common diseases such as obesity, diabetes mellitus, cardiovascular diseases and cancer. In these diseases, disturbances in the energy-sensing machinery possibly play a role. To determine the time course of energy sensing events in humans, the investigators will measure the concentration of various hormones in plasma, and biochemical changes in skeletal muscle at sequential time points during starvation in humans. The investigators choose to study the molecular machinery in muscle, since muscle is very sensitive to fuel deprivation.

Condition or disease Intervention/treatment
Nutrient Sensing During a Prolonged Fast Behavioral: Prolonged fasting

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Time Course and Nature of Nutrient Sensing During Fasting in Humans
Study Start Date : February 2011
Primary Completion Date : March 2011
Study Completion Date : March 2011

Arm Intervention/treatment
Experimental: 1
healthy young and lean men
Behavioral: Prolonged fasting
48 hours of fasting

Primary Outcome Measures :
  1. Change in several proteins/ribonucleic acid (RNA) from muscle biopsies upon fasting [ Time Frame: 1.5h, 4h, 10h, 24h ]

Secondary Outcome Measures :
  1. Change in several hormones, lipids etc. from blood samples upon fasting [ Time Frame: 1.5h, 4h, 10h, 24h ]

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Ages Eligible for Study:   19 Years to 29 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy males
  • Age 19-29 years old
  • Body mass index (BMI) 19-25 kg/m2
  • Stable weight for the last 3 months
  • Caucasian
  • Fasting plasma glucose (FPG) < 6 mmol/L
  • Well-controlled blood pressure (< 150/95 mmHg)
  • Creatinine <100 umol/l
  • Hb > 7.5 mmol/l
  • Negative family history (first degree) of type 2 diabetes mellitus (DM2)

Exclusion Criteria:

  • Use of medication known to affect glucose metabolism (for example prednisone) or lipid metabolism
  • Significant (chronic) disease
  • Smoking (current)
  • Alcohol consumption of more than 14 units per week at present or in the past
  • Difficult accessible veins for insertion of an intravenous catheter
  • Recent blood donation (within the last 3 months)
  • Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year
  • Rigorous exercise/sports 5 or more days a week

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01387919

Leiden University Medical Center
Leiden, Zuid-Holland, Netherlands, 2333ZA
Sponsors and Collaborators
Leiden University Medical Center
Centre for Medical Systems Biology
Principal Investigator: Hanno Pijl, MD, PhD Leiden University Medical Center

Responsible Party: Hanno Pijl, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT01387919     History of Changes
Other Study ID Numbers: P10.164
First Posted: July 6, 2011    Key Record Dates
Last Update Posted: July 11, 2011
Last Verified: January 2011

Keywords provided by Leiden University Medical Center:
Set time points during 48 hours of fasting