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| Name | Class |
|---|---|
| University of Graz | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alternate day fasting | Active Comparator | Subjects are requested to alternate fast for 4 weeks (alternate an ad libitum "feed day" with a 100% restriction "fast day"). |
|
| control group | No Intervention | control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alternate day fasting | Behavioral | Subjects are requested to fast every other day. Calorie free fluids are allowed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Sensitivity (HOMA-IR) | 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 | 4 weeks (from Baseline to 4 weeks) |
| Insulin Sensitivity (QUICKI) | QUICKI was calculated by using the following formula: QUICKI= log(FSI)+log (FPG) FSI=fasting serum insulin FPG=fasting plasma glucose | 4 weeks (from Baseline to 4 weeks) |
| Insulin Sensitivity (ISI-Index) | 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 | 4 weeks (from Baseline to 4 weeks) |
| Insulin Sensitivity (Matsuda-Index) | 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 | 4 weeks (from Baseline to 4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure (Systolic and Diastolic) | Change of blood pressure from Baseline to 4 weeks | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harald Sourij, MD | Medical University of Graz, Auenbruggerplatz 15 | Principal Investigator |
| Frank Madeo, PhD | Karl Franzens University Graz, Austria | Study Chair |
| Thomas R Pieber, MD | Medical University Graz, Austria | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Internal Medicine, Medical University of Graz | Graz | 8036 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30046988 | Background | Tripolt NJ, Stekovic S, Aberer F, Url J, Pferschy PN, Schroder S, Verheyen N, Schmidt A, Kolesnik E, Narath SH, Riedl R, Obermayer-Pietsch B, Pieber TR, Madeo F, Sourij H. Intermittent Fasting (Alternate Day Fasting) in Healthy, Non-obese Adults: Protocol for a Cohort Trial with an Embedded Randomized Controlled Pilot Trial. Adv Ther. 2018 Aug;35(8):1265-1283. doi: 10.1007/s12325-018-0746-5. Epub 2018 Jul 25. | |
| 31471173 |
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After interviewing 462 adults for study eligibility based on previously set inclusion and exclusion criteria we have selected 60 representative study participants for the randomized controlled trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Alternate Day Fasting | Subjects are requested to alternate fast for 4 weeks (alternate an ad libitum "feed day" with a 100% restriction "fast day"). Alternate day fasting: Subjects are requested to fast every other day. Calorie free fluids are allowed. |
| FG001 | Control Group | participants in the control group should be remaining on their usual diet |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Alternate Day Fasting | Subjects are requested to alternate fast for 4 weeks (alternate an ad libitum "feed day" with a 100% restriction "fast day"). Alternate day fasting: Subjects are requested to fast every other day. Calorie free fluids are allowed. |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Insulin Sensitivity (HOMA-IR) | 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 | per protocol analysis | Posted | Mean | Standard Deviation | no unit | 4 weeks (from Baseline to 4 weeks) |
|
During each study visit participants were asked about adverse events since the previous study visit. Adverse events were collected for 4 weeks (from study start to the end of the study).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alternate Day Fasting | Subjects are requested to alternate fast for 4 weeks (alternate an ad libitum "feed day" with a 100% restriction "fast day"). Alternate day fasting: Subjects are requested to fast every other day. Calorie free fluids are allowed. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Assoc.-Prof.Dr. Harald Sourij | Medical University of Graz | +43 316 385 | 78038 | norbert.tripolt@medunigraz.at |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 1, 2018 | May 14, 2020 | Prot_000.pdf |
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| Result |
| Stekovic S, Hofer SJ, Tripolt N, Aon MA, Royer P, Pein L, Stadler JT, Pendl T, Prietl B, Url J, Schroeder S, Tadic J, Eisenberg T, Magnes C, Stumpe M, Zuegner E, Bordag N, Riedl R, Schmidt A, Kolesnik E, Verheyen N, Springer A, Madl T, Sinner F, de Cabo R, Kroemer G, Obermayer-Pietsch B, Dengjel J, Sourij H, Pieber TR, Madeo F. Alternate Day Fasting Improves Physiological and Molecular Markers of Aging in Healthy, Non-obese Humans. Cell Metab. 2019 Sep 3;30(3):462-476.e6. doi: 10.1016/j.cmet.2019.07.016. Epub 2019 Aug 27. |
| 33512717 | Derived | Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2. |
participants in the control group should be remaining on their usual diet |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | per protocol analysis | Count of Participants | Participants |
|
| Race (NIH/OMB) | per protocol analysis | Count of Participants | Participants |
|
| Body weight | per protocol analysis | Mean | Standard Deviation | kg |
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| Primary | Insulin Sensitivity (QUICKI) | QUICKI was calculated by using the following formula: QUICKI= log(FSI)+log (FPG) FSI=fasting serum insulin FPG=fasting plasma glucose | per protocol analysis | Posted | Median | Inter-Quartile Range | no unit | 4 weeks (from Baseline to 4 weeks) |
|
|
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| Primary | Insulin Sensitivity (ISI-Index) | 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 | per protocol analysis | Posted | Median | Inter-Quartile Range | no unit | 4 weeks (from Baseline to 4 weeks) |
|
|
|
| Primary | Insulin Sensitivity (Matsuda-Index) | 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 | per protocol analysis | Posted | Median | Inter-Quartile Range | no unit | 4 weeks (from Baseline to 4 weeks) |
|
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| Secondary | Blood Pressure (Systolic and Diastolic) | Change of blood pressure from Baseline to 4 weeks | per protocol analysis | Posted | Median | Inter-Quartile Range | mmHg | 4 weeks |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Control Group | Participants in the control group should be remaining their normal diet | 0 | 30 | 0 | 30 | 0 | 30 |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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