The Intermittent Fasting ZOE Health Study: Effects on Hunger, Mood, Energy and Symptom Burden in a UK Cohort
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150,000
- 试验地点
- 2
- 主要终点
- TRE window clock time
研究概览
简要总结
The timing of food intake (chrononutrition) is emerging as a key regulator of circadian rhythm in metabolic organs. A wealth of research has been conducted on intermittent fasting, and time restricted eating (TRE) specifically, investigating the temporal patterns of diet (eating window, time of eating, time of largest energy intake) and their impact on disease risk, with overall beneficial impact on health. Studies have been conducted in a parallel or single arm design, while cross-over and the efficacy of TRE in ameliorating appetite and symptom burden within an individual remains unclear.
详细描述
Time Restricted Eating (TRE; a type of intermittent fasting) is a dietary pattern based on the 24h day. Practicing individuals restrict their eating/feeding window to a certain number of hours, e.g. 4h, while the remaining hours in the day are non-feeding (fasting) time. The eating window is the duration of time from the start of the first meal to the end of the last meal in a 24 hr period. The eating window in a general population has previously been quantified at 12h (American cohort of n=15,000). It is important to note that TRE differs from other intermittent fasting protocols by (i) not specifying a change in dietary intake, such as requiring caloric restriction, but rather specifying the temporal pattern of intake; and (ii) requiring consistent daily eating windows over several days. TRE protocols can vary in the length of the eating window, as well as the anchoring of that window to the time of day, such that early vs. middle vs. late TRE regimens exist.
While the cardiometabolic benefits TRE are well established by human trials, other outcomes of dietary compliance remain unexplored and thus bring into question the sustainability of and adherence to TRE as a long-term dietary regimen. Perception of hunger, mood and energy, and self-elected timings of TRE eating windows while following the dietary pattern are not well understood. In particular, the relative differences in these outcomes between an habitual and a TRE eating pattern within the same individual must be determined in order to truly evaluate the acceptability of TRE on a per-individual basis.
The Intermittent Fasting Study, a sub-study of the ZOE Health Study (ZHS), will test the effects of habitual eating patterns vs. a TRE protocol on hunger, mood, energy and symptom burden in an adult UK cohort using the ZHS app.
Population:
This study is open to all participants currently enrolled in the ZHS study tracking physical and mental symptom burden on a daily basis. Participants will be invited to take part in the Intermittent Fasting Study and must provide their consent in order to participate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants on the ZOE Health Study (ZHS) app are accepted onto the study if they wish to participate and are within the UK.
- •The ZHS eligibility criteria are as follows:
- •Inclusion Criteria:
- •Adults of 18 years and above, where the app has been approved for download from the Apple App and Google Play stores.
排除标准
- •Unable to provide written informed consent
结局指标
主要结局
TRE window clock time
时间窗: 2 weeks
The chosen clock time for the TRE window (early, vs. middle, vs. late)
Energy
时间窗: 3 weeks (plus optional unlimited weeks)
Energy levels reported by visual analogue scale ("how energetic did you feel yesterday?"; 0-10; where 10 is most energetic)
Symptom burden
时间窗: 3 weeks (plus optional unlimited weeks)
The self-reported symptom burden while completing both habitual and TRE phases
Mood
时间窗: 3 weeks (plus optional unlimited weeks)
Mood levels reported by visual analogue scale ("how was your mood yesterday?"; 0-10; where 10 is most positive)
Habitual eating window clock time
时间窗: 1 weeks
The chosen clock time for the habitual eating window
Hunger
时间窗: 3 weeks (plus optional unlimited weeks)
Hunger levels reported by visual analogue scale ("how hungry did you feel yesterday?"; 0-10; where 10 is the most hungry)
次要结局
- Body weight(3 weeks (plus optional unlimited weeks))
- Gastrointestinal symptoms(3 weeks (plus optional unlimited weeks))
- Eating habits(3 weeks (plus optional unlimited weeks))