Time Course and Nature of Nutrient Sensing During Fasting in Humans

Study Overview
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Brief Summary
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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.

Official Title
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Time Course and Nature of Nutrient Sensing During Fasting in Humans

Conditions
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Nutrient Sensing During a Prolonged Fast

Intervention / Treatment
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* Behavioral: Prolonged fasting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>healthy young and lean men | Behavioral: Prolonged fasting<br>* 48 hours of fasting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in several proteins/ribonucleic acid (RNA) from muscle biopsies upon fasting |  | 1.5h, 4h, 10h, 24h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in several hormones, lipids etc. from blood samples upon fasting |  | 1.5h, 4h, 10h, 24h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Set time points during 48 hours of fasting