Stekovic 2019.
Study characteristics | ||
Methods | Randomised controlled trial | |
Participants | 60 participants based in Australia aged between 35 and 65 with a BMI between 22.0 and 30.0 kg/m2 Inclusion criteria: age between 35 and 65 years, both inclusive
Exclusion criteria:
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Interventions |
2‐arm trial Intervention (n = 29): ADF 25% of caloric intake Comparator (n = 28): control/ad libitum feeding |
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Outcomes | Body weight change, BMI, blood pressure | |
Notes |
Funding and acknowledgements: F.M. is grateful to the Austrian Science Fund FWF (SFB LIPOTOX F3007& F3012, W1226, P29203, P29262, P27893, P 31727), the Austrian Federal Ministry of Education, Science and Research, and the University of Graz for grants “Unkonventionelle Forschung‐InterFast” and “ flysleep” (BMWFW-80.109/0001-WF/V/3b/2015), as well as the field of excellence program BioHealth. We acknowledge support from NAWI Graz and the BioTechMed‐Graz flagship project “EPIAge.” G.K. is supported by the Ligue Contre le Cancer Comité de Charente‐Maritime (équipe labelisée); Agence National de la Recherche (ANR)–Projets blancs; ANR under the frame of E‐Rare‐2, the ERA‐Net for Research on Rare Diseases; Association pour la Recherche sur le Cancer (ARC); Cancéropôle Île‐de‐France;Institut National du Cancer (INCa); Institut Universitaire de France; Fondation pour la Recherche Médicale (FRM); the European Commission (ArtForce); the European Research Council (ERC); the Leducq Foundation; the Labex Immuno‐Oncology; the Recherche Hospitalo‐Universitaire Torino Lumière, the Site de Recherche Intégrée sur le Cancer (SIRIC) Stratified Oncology Cell DNA Repair and Tumor Immune Elimination (SOCRATE); the SIRIC Cancer Research and Personalized Medicine (CARPEM); and the Paris Alliance of Cancer Research Institutes (PACRI). T.E. is supported by the FFG COIN‐project 855987 . J.D. is supported by the Canton of Fribourg and the Swiss National Science Foundation. M.A.A. and R.d.C. are funded by the IRP of the NIA, NIH. H.S. is grateful to support from the K1 Comet Center CBmed (Center for Biomarker Research in Medicine) funded by the Austrian Research Promotion Agency (FFG) and the Styrian Research Agency (SFG). Type of paper: full‐text publication ADF‐ alternate day fasting |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The randomization was conducted using an online tool "Randomizer for Clinical Trials’’ (https://www.randomizer.at/) and stratifying participants by sex." |
Allocation concealment (selection bias) | High risk | Quote: "While we were not able to blind participants regarding their intervention, allocation, clinical, and scientific staff were blinded during the process of collection, archiving, and analyses of collected samples and measurements." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Since this trial was a dietary intervention study, it was not feasible for participants or all study personnel to be blinded to the group assignment. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote:"clinical, and scientific staff were blinded during the process of collection, archiving, and analyses of collected samples and measurements." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The dropout rates were relatively low for both groups; during these 4 weeks of intervention, 1 participant out of 30 (3.3%) dropped out of the ADF group and 2 participants out of 30 (6.7%) dropped out of the control group 3 participants. |
Selective reporting (reporting bias) | Unclear risk | Outcomes not pre‐specified. |
Other bias | Unclear risk | Not clear. |