Excessive Diet RestrictionInterFastNCT02673515

The Impact of Intermittent Fasting on Human Metabolism and Cell Autophagy

A study testing Alternate day fasting in people with Excessive Diet Restriction, run by Medical University of Graz at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 35 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Excessive Diet Restriction
What is being tested?: Alternate day fasting
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteAustria
Study dates: Apr 2015to 2 Sep 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Body mass index in the range of 22.0 - 27.0 kg/m2,
Fasting blood glucose <110mg/dL (without medication)
LDL-cholesterol <180 mg/dL (without medication)
Blood pressure <140/90 mmHg (without medication)
Stable weight (change <± 10%) for 3 months immediately prior to the study,
No history of metabolic disorders or cardiovascular disease

Show all 11Show fewer

No acute or chronic inflammatory disorder
No current medications to regulate blood sugar, blood pressure or lipids or hormones
No heavy drinking (more than 15 drinks/week)
No use of tobacco or recreational drugs within past 5 years
No dietary restrictions (e.g. vegetarianism and vegan)

Who cannot join

Known Malignancy
Women who are pregnant, breast-feeding or trying to become pregnant
History of any chronic disease process that could interfere with interpretation of study results
Women or men on hormonal supplementation or anti-conceptive hormonal medication for at least 2 months
Therapy with antidepressants within past 6 months
Regular therapy with acetylsalicylic acid

Trial locations and contacts

1 site in 1 country.

Austria1 site

Dept. of Internal Medicine, Medical University of Graz
Graz, 8036

Other trials in Austria

About this study

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.

Read the detailed description

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.

Conditions: Excessive Diet Restriction
Being tested: Alternate day fasting
Keywords: Alternate Day Fasting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Alternate day fastingBehavioural
Subjects are requested to fast every other day. Calorie free fluids are allowed.

Study groups in NCT02673515
Study group	Role	What they receive
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"). Receives: Behavioral: Alternate day fasting
control group	No intervention	control group

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 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
Measured: 4 weeks (from Baseline to 4 weeks)

Secondary outcomes (1)

Blood Pressure (Systolic and Diastolic)
Change of blood pressure from Baseline to 4 weeks
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 20152 Sep 2019

First posted4 Feb 2016 (estimated)
Study startApr 2015
Primary completion2 Sep 2019
Study completion2 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Excessive Diet RestrictionStudies of the same condition, open and under way.
More trials run by Medical University of GrazThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02673515
Sponsor's protocol ID: HS-2014-03
Acronym: InterFast
Status last verified: May 2020
First submitted: 24 Nov 2015
Last updated: 28 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

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.
PubMed 30046988
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.
PubMed 31471173
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.
PubMed 33512717

Study at a glance

From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of Intermittent Fasting on Human Metabolism and Cell Autophagy
ClinicalTrials.gov ID: NCT02673515
Acronym / sponsor ID: InterFast / HS-2014-03
Conditions: Excessive Diet Restriction
Keywords: Alternate Day Fasting
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Medical University of GrazUniversity, hospital or other
Collaborators: University of Graz
Study start: Apr 2015
Primary completion: 2 Sep 2019 (actual)
Study completion: 2 Sep 2019 (actual)
First posted: 4 Feb 2016 (estimated)
Results: Posted 28 May 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Alternate day fasting	Active comparator	Behavioral: Alternate day fastingSubjects 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

Who may qualify

Ages: 35 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Body mass index in the range of 22.0 - 27.0 kg/m2,
Fasting blood glucose <110mg/dL (without medication)
LDL-cholesterol <180 mg/dL (without medication)
Blood pressure <140/90 mmHg (without medication)
Stable weight (change <± 10%) for 3 months immediately prior to the study,

Key exclusion criteria (6 listed)

Known Malignancy
Women who are pregnant, breast-feeding or trying to become pregnant
History of any chronic disease process that could interfere with interpretation of study results
Women or men on hormonal supplementation or anti-conceptive hormonal medication for at least 2 months
Therapy with antidepressants within past 6 months

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Alternate day fastingSubjects are requested to fast every other day. Calorie free fluids are allowed.	Behavioural	Alternate day fasting

Primary outcome

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

1 secondary outcome

Blood Pressure (Systolic and Diastolic)
Time frame: 4 weeks

Results and safety

Results posted to the registry on 28 May 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Alternate Day Fasting	30	28
Control Group	30	29

Primary outcome: Insulin Sensitivity (HOMA-IR)

Time frame: 4 weeks (from Baseline to 4 weeks). Mean (Standard Deviation). Unit: no unit

Measure	Alternate Day Fasting n = 28	Control Group n = 29
Value	0.05 (0.95)	0.06 (0.80)

Population analysed: per protocol analysis

Primary outcome: Insulin Sensitivity (QUICKI)

Time frame: 4 weeks (from Baseline to 4 weeks). Median (Inter-Quartile Range). Unit: no unit

Measure	Alternate Day Fasting n = 28	Control Group n = 29
Value	0 (-0.02 to 0.02)	0 (-0.03 to 0.01)

Population analysed: per protocol analysis

Primary outcome: Insulin Sensitivity (ISI-Index)

Time frame: 4 weeks (from Baseline to 4 weeks). Median (Inter-Quartile Range). Unit: no unit

Measure	Alternate Day Fasting n = 28	Control Group n = 29
Value	0 (0 to 0.01)	0 (0.0 to 0.01)

Population analysed: per protocol analysis

Primary outcome: Insulin Sensitivity (Matsuda-Index)

Time frame: 4 weeks (from Baseline to 4 weeks). Median (Inter-Quartile Range). Unit: no unit

Measure	Alternate Day Fasting n = 28	Control Group n = 29
Value	-0.4 (-4.6 to 3.3)	-0.7 (-5.4 to 1.8)

Alternate Day Fasting vs Control Group: p = 0.797, t-test, 2 sided

Population analysed: per protocol analysis

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 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).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Alternate Day Fasting	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Control Group	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30046988Tripolt 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.
Results publication: PubMed 31471173Stekovic 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.
Derived from this study: PubMed 33512717Allaf 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Harald Sourij, MD principal investigator

Medical University of Graz, Auenbruggerplatz 15

Frank Madeo, PhD study chair

Karl Franzens University Graz, Austria

Thomas R Pieber, MD study chair

Medical University Graz, Austria

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Alternate day fasting in people with Excessive Diet Restriction, run by Medical University of Graz at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insulin Sensitivity (HOMA-IR) (time frame: 4 weeks (from Baseline to 4 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02673515, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2020.