Charité- Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Social Medicine, Epidemiology and Health Economics, Berlin, Germany; Immanuel Hospital Berlin, Department of Internal and Complementary Medicine, Berlin, Germany.
Immanuel Hospital Berlin, Department of Internal and Complementary Medicine, Berlin, Germany.
Nutrition. 2018 Feb;46:143-152.e2. doi: 10.1016/j.nut.2017.08.004. Epub 2017 Aug 12.
The aim of the study was to evaluate whether intermittent fasting (IF) is an effective preventive measure, and whether it is feasible for healthy volunteers under every day conditions.
A nonrandomized controlled clinical trial on IF was performed with healthy volunteers over a period of 8 wk, and a subsequent 4-mo follow-up. Outcomes were assessed at baseline, after 8 wk, and after 6 mo. Volunteers who were not interested in fasting served as a control group. Participants in the fasting group were asked to continue their regular nutritional habits on the nonfasting days, whereas the control group maintained their habitual nutrition throughout the whole period. Outcomes included changes of metabolic parameters (insulin, glucose, insulin resistance, insulin-like growth factor-1, brain-derived neurotropic factor, lipids, liver enzymes, hemoglobin A1c) and coagulation markers; bioelectrical impedance analysis; body mass index; abdominal girth; blood pressure; general quality of life (five-item World Health Organization Well-Being Index [WHO-5] questionnaire), as well as mood and anxiety (Hospital Anxiety and Depression Scale [HADS], Profile of Mood States, Flourishing-Scale, visual analog scale, Likert scales). The intervention consisted of a fasting day, which was repeated every week for 8 wk, with abstinence from solid food between 00:00 and 23:59 at minimum and a maximum caloric intake of 300 kcal on each fasting day. A per-protocol analysis was performed. P < 0.05 was considered significant.
Thirty-six volunteers were included; 22 allocated themselves to the fasting group, and 14 to the control group. Thirty-three data sets were included in the final analysis. Although significant in-group changes were observed in both groups for a number of outcomes after 8 wk and 6 mo, no significant between-group differences were observed for any outcome other than overall body fat mass after 8 wk as well as for the HADS total score and the WHO-5 total score after 6 mo, all in favor of the fasting group. However, none of the between-group differences were clinically relevant.
We did not find any clinically relevant differences between groups in this controlled clinical pilot trial of 8 wk of IF in healthy volunteers. Further clinical research in this field is warranted to further analyze mechanisms and effects of IF.
本研究旨在评估间歇性禁食（IF）是否是一种有效的预防措施，以及对于日常条件下的健康志愿者是否可行。
对健康志愿者进行了为期 8 周的非随机对照临床试验，并进行了随后的 4 个月随访。在基线、8 周后和 6 个月后评估结果。对不感兴趣禁食的志愿者作为对照组。禁食组的参与者被要求在非禁食日继续他们的常规营养习惯，而对照组则在整个期间保持他们的习惯性营养。结果包括代谢参数（胰岛素、葡萄糖、胰岛素抵抗、胰岛素样生长因子-1、脑源性神经营养因子、脂质、肝酶、血红蛋白 A1c）和凝血标志物的变化；生物电阻抗分析；体重指数；腹围；血压；一般生活质量（五项世界卫生组织幸福指数[WHO-5]问卷），以及情绪和焦虑（医院焦虑和抑郁量表[HADS]、情绪状态概况、繁荣量表、视觉模拟量表、李克特量表）。干预措施包括禁食日，每周重复一次，禁食时间至少为 00:00 至 23:59，每个禁食日的最大热量摄入为 300 千卡。进行了意向治疗分析。P<0.05 被认为具有统计学意义。
共纳入 36 名志愿者，其中 22 名志愿者分配到禁食组，14 名志愿者分配到对照组。最终分析纳入 33 个数据集。尽管在 8 周和 6 个月后，两组的许多结果都显示出显著的组内变化，但除了 8 周后的总体体脂肪量以及 6 个月后的 HADS 总分和 WHO-5 总分外，两组之间没有观察到任何其他结果的显著组间差异，所有这些结果都有利于禁食组。然而，组间差异均无临床意义。
在这项为期 8 周的健康志愿者间歇性禁食的对照临床试验中，我们没有发现组间有任何临床相关差异。需要进一步的临床研究来进一步分析 IF 的机制和效果。
