Excessive Diet Restriction Clinical Trial
Official title:
The Impact of Intermittent Fasting on Human Metabolism and Cell Autophagy
InterFast is a Cohort study with an embedded randomized controlled pilot trial. Study participants will be healthy subjects and subjects who already practice Alternate Day Fasting. The trial will include 100 participants (50 Participants in Alternate Day Fasting group and 50 participants in the control group). Those participants in the control group will be asked to participate in a short randomized controlled trial, where they will be either allocated to an Alternative Day Fasting group or another control visit.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00943215 -
How Participants Behave and Respond on Their Own After Completing a 2-year Intervention of Calorie Restriction
|
N/A |