The Impact of Intermittent Fasting on Human Metabolism and Cell Autophagy

NCT02673515 | Completed Results DMC

• 1 other identifier: HS-2014-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Excessive Diet Restriction

Keywords

Alternate Day Fasting

Outcome Measures

Primary Outcomes (4)

• 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)

Secondary Outcomes (1)

• Blood Pressure (Systolic and Diastolic)

  4 weeks

Study Arms (2)

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").

Behavioral: Alternate day fasting

control group

NO INTERVENTION

control group

Interventions

Alternate day fasting BEHAVIORAL

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

Alternate day fasting

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead
• University of Graz: collaborator

Study Sites (1)

Dept. of Internal Medicine, Medical University of Graz

Graz, 8036, Austria

Location

Related Publications (3)

• 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.

  PMID: 30046988 BACKGROUND

• 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.

  PMID: 31471173 RESULT

• 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.

  PMID: 33512717 DERIVED

Results Point of Contact

• Title: Assoc.-Prof.Dr. Harald Sourij
• Organization: Medical University of Graz

norbert.tripolt@medunigraz.at

+43 316 385

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: February 4, 2016
• Study Start: April 1, 2015
• Primary Completion: September 2, 2019
• Study Completion: September 2, 2019
• Last Updated: May 28, 2020
• Results First Posted: May 28, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)