Cho 2019.
Study characteristics | ||
Methods | Multiple‐arm randomised controlled clinical trial | |
Participants | 112 participants based in South Korea aged between 20 and 65 with a BMI > 23. Inclusion criteria and exclusion criteria: Eligibility requirements were: age 20–65 years; BMI >23.0 kg/m2 (overweight or obese for Asian populations, according to the World Health Organization [17]); stable weight for 3 months prior to the study (i.e. weight loss or weight gain <5 kg); no history of bariatric surgery; no secondary obesity, such as hypothyroidism; non‐diabetic; aspartate amino‐transferase (ASP) or alanine amino‐transferase (ALT) levels < 200 mg/dL; serum creatinine level < 2.0 mg/dL, no pancreatitis or related disorders; no acute infectious diseases (i.e. pneumonia, acute enteritis, or urinary infection); no chronic inflammatory diseases (i.e. rheumatoid arthritis, or lupus); no history of cardiovascular diseases; no history of cancer; not taking anti‐obesity, anti‐diabetic, diuretic, central‐nervous system, antidepressant, antipsychotic, or steroid medications; no pregnant or lactating women; no overeating behaviour; no >30 g of daily alcohol intake; not a night‐time or shift‐work worker; no chronic malabsorption syndrome or cholestasis; no other medical conditions that would preclude subjects from participating in exercise and physical test. |
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Interventions |
2‐arm trial Intervention (n = 8): modified alternate day fasting (25% of normal) Comparator (n = 5): ad libitum feeding |
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Outcomes | Body weight, BMI, lipid profile, CRP, glucose | |
Notes |
Type of paper: full‐text publication Funding: This study was supported by a 2013 Faculty Research Grant from the Yonsei University College of Medicine (6-2013-0021) and the Bio & Medical Technology Development Program, through the National Research Foundation of Korea funded by the Ministry of Science and ICT (NRF-2013M3A9B6046413, NRF-2018R1D1A1B07049223). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote:"Block randomization was performed with a computer‐generated random number sequence. An independent statistician generated the allocation sequence." |
Allocation concealment (selection bias) | Unclear risk | Quote:"An independent statistician generated the allocation sequence, and the study coordinator assigned the participants to interventions in chronological order as the participants enrolled. Only outcome assessors were blinded to group allocation" It is unclear what was meant by assignment in chronological order, and this statement suggests that the allocation sequence was not concealed from the study coordinators, in contradiction to the later statement that "only outcome assessors were blinded to group allocation". |
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 | Only outcome assessors were blinded to group allocation |
Incomplete outcome data (attrition bias) All outcomes | High risk | High rates of dropout; Dropout of 7 out of 26 participants (26.9%) in ADF group. Dropout of 6 out of 22 participants (27.3%) in control group |
Selective reporting (reporting bias) | Low risk | All outcomes pre‐specified in the Methods section were reported in the Results section. An assessment based on ClinicalTrials.gov (NCT03652532) cannot be made because the trial was registered post‐hoc. |
Other bias | Low risk | Nothing to note. |