Intermittent Fasting (Alternate Day Fasting) in Healthy, Non-obese Adults: Protocol for a Cohort Trial with an Embedded Randomized Controlled Pilot Trial.

Autor: Tripolt NJ; Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria., Stekovic S; Institute of Molecular Biosciences, University of Graz, Graz, Austria., Aberer F; Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria., Url J; Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.; Center for Biomarker Research in Medicine, CBMed, Graz, Austria., Pferschy PN; Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.; Center for Biomarker Research in Medicine, CBMed, Graz, Austria., Schröder S; Institute of Molecular Biosciences, University of Graz, Graz, Austria., Verheyen N; Division of Cardiology, Department of Internal Medicine, Medical University of Graz, Graz, Austria., Schmidt A; Division of Cardiology, Department of Internal Medicine, Medical University of Graz, Graz, Austria., Kolesnik E; Division of Cardiology, Department of Internal Medicine, Medical University of Graz, Graz, Austria., Narath SH; Center for Biomarker Research in Medicine, CBMed, Graz, Austria., Riedl R; Institute for Medical Informatics, Statistics and Documentation, Medical University of Graz, Graz, Austria., Obermayer-Pietsch B; Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.; Center for Biomarker Research in Medicine, CBMed, Graz, Austria., Pieber TR; Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.; Center for Biomarker Research in Medicine, CBMed, Graz, Austria., Madeo F; Institute of Molecular Biosciences, University of Graz, Graz, Austria. frank.madeo@uni-graz.at.; BioTechMed Graz, Graz, Austria. frank.madeo@uni-graz.at., Sourij H; Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria. ha.sourij@medunigraz.at.; Center for Biomarker Research in Medicine, CBMed, Graz, Austria. ha.sourij@medunigraz.at.
Jazyk: angličtina
Zdroj: Advances in therapy [Adv Ther] 2018 Aug; Vol. 35 (8), pp. 1265-1283. Date of Electronic Publication: 2018 Jul 25.
DOI: 10.1007/s12325-018-0746-5
Abstrakt: Background/objectives: Alternate day fasting (ADF) is a subtype of intermittent fasting and is defined as a continuous sequence of a fast day (100% energy restriction, zero calories) and a feed day (ad libitum food consumption), resulting in roughly 36-h fasting periods. Previous studies demonstrated weight reductions and improvements of cardiovascular risk factors with ADF in obese subjects. However, rigorous data on potential endocrine, metabolic and cardiovascular effects, besides weight loss, are lacking. Therefore we aim to investigate the short- and mid- to long-term clinical and molecular effects of ADF in healthy non-obese subjects.
Methods: We will perform a prospective cohort study with an embedded randomized controlled trial (RCT) including 90 healthy subjects. Thirty of them will have performed ADF for at least 6 months (mid-term group). Sixty healthy subjects without a particular diet before enrolment will serve as the control group. These subjects will be 1:1 randomized to either continuing their current diet or performing ADF for 4 weeks. All subjects will undergo study procedures that will be repeated in RCT participants after 4 weeks. These procedures will include assessment of outcome parameters, dual-energy X-ray absorptiometry, measurement of endothelial function, an oral glucose tolerance test, 24-h blood pressure measurement, retinal vessel analysis, echocardiography and physical activity measurement by an accelerometer. Blood, sputum, buccal mucosa and faeces will be collected for laboratory analyses. Participants in the RCT will wear a continuous glucose monitor to verify adherence to the study intervention.
Planned Outcomes: The aim of this project is to investigate the effects of ADF on human physiology and molecular cellular processes. This investigation should gain in-depth mechanistic insights into the concept of ADF and form the basis for larger subsequent cohort recruitment and consecutive intervention studies.
Trial Registration: NCT02673515; registered 24 November 2015. Current protocol date/version: 7 February 2017/version 1.8.
Databáze: MEDLINE
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