Intermittent Fasting (Alternate Day Fasting) in Healthy, Non-obese Adults: Protocol for a Cohort Trial with an Embedded Randomized Controlled Pilot Trial
Tripolt NJ, Stekovic S, Aberer F, Url J, Pferschy PN, Schröder S, Verheyen N, Schmidt A, Kolesnik E, Narath SH, Riedl R, Obermayer-Pietsch B, Pieber TR, Madeo F, Sourij H
Advances in therapy · 20 citas
Cómo se estudió
- Diseño
- Estudio de cohortes (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- Austrian Science Fund
- Universidad u hospital
- BioTechMed-Graz
- Gobierno
- Austrian Science Fund FWF
- Subvenciones
- Austrian Science Fund (P 27893); Austrian Science Fund (P29203); Austrian Science Fund (P 29262)
Según 3 financiadores declarados y la declaración de financiación del texto completo.
Publicación
- Publicado
- 2018-07-25 · Adv Ther · vol. 35 · número 8 · págs. 1265–1283
- Editorial
- Adis, Springer Healthcare
- Citado
- 23 citas · más que el 86% de estudios similares · 1.9× el promedio de su campo
- Referencias
- 63 trabajos
- Acceso
- Acceso abierto (revista híbrida) · CC-BY-NC
- Áreas de investigación
- Dietary Effects on Health · Diet and metabolism studies · Genetics, Aging, and Longevity in Model Organisms
- Palabras clave
- Medicine, Randomized controlled trial, Intermittent fasting, Cohort, Calorie, Weight loss, Internal medicine, Blood pressure, Physical therapy, Obesity
- MeSH
- humans, hypertension, obesity, blood glucose, clinical protocols, caloric restriction, fasting, cohort studies, prospective studies, pilot projects, energy intake, adult, female, male, randomized controlled trials as topic
15 autores
- Norbert Joachim Tripolt🇦🇹Medical University of Graz
- Slaven Stekovic🇦🇹University of Graz
- Felix Aberer🇦🇹Medical University of Graz
- Jasmin Url🇦🇹Medical University of Graz; Center For Biomarker Research In Medicine
- Peter N. Pferschy🇦🇹Medical University of Graz; Center For Biomarker Research In Medicine
- Sabrina S. Schröder🇦🇹University of Graz
- Nicolas Verheyen🇦🇹Medical University of Graz
- Albrecht G. Schmidt🇦🇹Medical University of Graz
- Ewald Kolesnik🇦🇹Medical University of Graz
- Sophie H Narath🇦🇹Center For Biomarker Research In Medicine
- Regina Riedl🇦🇹Medical University of Graz
- Barbara Maria Obermayer-Pietsch🇦🇹Medical University of Graz; Center For Biomarker Research In Medicine
- Thomas Rudolf Pieber🇦🇹Medical University of Graz; Center For Biomarker Research In Medicine
- Frank Madeo🇦🇹 · autor de correspondenciaUniversity of Graz; BioTechMed-Graz
- Harald Sourij🇦🇹 · autor de correspondenciaMedical University of Graz; Center For Biomarker Research In Medicine
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY-NC).
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