The Impact of Intermittent Fasting on Human Metabolism and Cell Autophagy (InterFast)

May 14, 2020 updated by: Medical University of Graz
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 weeks (from Baseline to 4 weeks)
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
4 weeks (from Baseline to 4 weeks)
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
4 weeks (from Baseline to 4 weeks)
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
4 weeks (from Baseline to 4 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure (Systolic and Diastolic)
Time Frame: 4 weeks
Change of blood pressure from Baseline to 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Collaborators

University of Graz

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

September 2, 2019

Study Completion (Actual)

September 2, 2019

Study Registration Dates

First Submitted

November 24, 2015

First Submitted That Met QC Criteria

February 3, 2016

First Posted (Estimate)

February 4, 2016

Study Record Updates

Last Update Posted (Actual)

May 28, 2020

Last Update Submitted That Met QC Criteria

May 14, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HS-2014-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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