The Impact of Intermittent Fasting on Human Metabolism and Cell Autophagy (InterFast)
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|ClinicalTrials.gov Identifier: NCT02673515|
Recruitment Status : Completed
First Posted : February 4, 2016
Results First Posted : May 28, 2020
Last Update Posted : May 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Excessive Diet Restriction||Behavioral: Alternate day fasting||Not Applicable|
Intermittent fasting is a dietary regimen defined by alternating fasting and "feeding" cycles. In addition to caloric restriction (a dietary regimen limited to a daily food intake lower than one's daily caloric needs) only, intermittent fasting seems to activate cell autophagy (cellular "recycling" program) which potentially increases cellular stress resistance and removes accumulated molecules that are potentially toxic. In fact, mice maintained on intermittent fasting without decreased overall food intake show effects on body weight reduction that equal and in some cases even exceed those of calorie restriction. However, additionally, intermittent fasting combined with even a high-fat diet in the feeding periods protects mice from obesity, hyperinsulinemia, hepatic steatosis, and inﬂammation compared to controls that are fed an ad libitum high-fat diet despite the same calorie intake, making this intermittent fasting regimen a promising approach to reduce morbidity and mortality in various species.
The best described and most widely practiced version of intermittent fasting is the "alternate day diet" or "alternate day fasting" (ADF). In animal models, ADF consists of an ad libitum "feed day" alternated with a 100% restriction "fast day". However in humans, this is often modified to allow a small amount of food consumption on the "fast day" (e.g. 25% of the individual´s energy needs). Findings from recent modified ADF studies showed significant reductions in body weight.
However, knowledge about the molecular effects of the alternate day diet on human metabolism or autophagy is still scarce since detailed analyses of molecular and metabolic parameters remain unexplored, especially in healthy individuals. The overarching aim of this research project is to elucidate in which extent alternate day fasting (and thereby intermittent fasting) influences human physiology in healthy individuals in both short and long term. The secondary objective of this study is to define novel molecular markers of aging and age-related diseases.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||The Impact of Intermittent Fasting on Human Metabolism and Cell Autophagy|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||September 2, 2019|
|Actual Study Completion Date :||September 2, 2019|
Active Comparator: Alternate day fasting
Subjects are requested to alternate fast for 4 weeks (alternate an ad libitum "feed day" with a 100% restriction "fast day").
Behavioral: Alternate day fasting
Subjects are requested to fast every other day. Calorie free fluids are allowed.
No Intervention: control group
- Insulin Sensitivity (HOMA-IR) [ Time Frame: 4 weeks (from Baseline to 4 weeks) ]
HOMA-Index was calculated by using the following formula:
HOMA-IR= FPG(mmol/l)*FSI (U/l)/22.5 FSI=fasting serum insulin FPG=fasting plasma glucose
- Insulin Sensitivity (QUICKI) [ Time Frame: 4 weeks (from Baseline to 4 weeks) ]QUICKI was calculated by using the following formula: QUICKI= log(FSI)+log (FPG) FSI=fasting serum insulin FPG=fasting plasma glucose
- Insulin Sensitivity (ISI-Index) [ Time Frame: 4 weeks (from Baseline to 4 weeks) ]ISI was calculated by using the following formula: ISI=0,222−0,00333 x BMI−0,0000779 x Ins120−0,000422 x age FSI=fasting serum insulin FPG=fasting plasma glucose
- Insulin Sensitivity (Matsuda-Index) [ Time Frame: 4 weeks (from Baseline to 4 weeks) ]
Matsuda index was calculated by using the following formula:
Matsuda-Index = 10000√(FPG∗FSI)∗(mean glucose*mean insulin) FSI=fasting serum insulin FPG=fasting plasma glucose
- Blood Pressure (Systolic and Diastolic) [ Time Frame: 4 weeks ]Change of blood pressure from Baseline to 4 weeks
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): NCT02673515
|Dept. of Internal Medicine, Medical University of Graz|
|Graz, Austria, 8036|
|Principal Investigator:||Harald Sourij, MD||Medical University of Graz, Auenbruggerplatz 15|
|Study Chair:||Frank Madeo, PhD||Karl Franzens University Graz, Austria|
|Study Chair:||Thomas R Pieber, MD||Medical University Graz, Austria|