The Impact of Intermittent Fasting on Human Metabolism and Cell Autophagy

NCT ID: NCT02673515

Last Updated: 2020-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2019-09-02

Brief Summary

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Alternate day fasting

Subjects are requested to alternate fast for 4 weeks (alternate an ad libitum "feed day" with a 100% restriction "fast day").

Group Type: ACTIVE_COMPARATOR

Alternate day fasting

Intervention Type: BEHAVIORAL

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

control group

control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Alternate day fasting

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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
• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Graz

OTHER

Sponsor Role: collaborator

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harald Sourij, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz, Auenbruggerplatz 15

Frank Madeo, PhD

Role: STUDY_CHAIR

Karl Franzens University Graz, Austria

Thomas R Pieber, MD

Role: STUDY_CHAIR

Medical University Graz, Austria

Locations

Dept. of Internal Medicine, Medical University of Graz

Graz, , Austria

Countries

Austria

References

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.

Reference Type: BACKGROUND

PMID: 30046988 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31471173 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33512717 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

HS-2014-03

Identifier Type: -

Identifier Source: org_study_id