Physiological and Sensory Responses to Prolonged Fasting in Humans
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Change in postprandial insulin responses
研究概览
简要总结
This study aims to establish the metabolic/molecular response in both adipose tissue and skeletal muscle as well as sensory experiences (pain, fatigue, drive) to prolonged fasting of 3 days duration. Participants will undergo sequential meal assessment before and after a 3 day fast with measures taken throughout each fasting day.
详细描述
This study will employ a single-arm, non-randomised design in which participants will act as their own control prior to undergoing 3 days of fasting. The control phase includes 3 days of habitual energy balance assessment before coming into the laboratory for baseline meal testing with blood, muscle, and adipose samples as well as anthropometric assessment.
Participants will then be provided with a standardised lunch to be consumed around midday and a standardised dinner to be consumed at 2000 h.
Participants will then be asked to refrain from caloric intake for 3 days until they return to the laboratory for follow up measures.
Participants will be provided with monitoring equipment throughout the 3 days of fasting and will be asked to provide a blood sample at 0800 h each day alongside self recording of blood pressure, weight, and urinary ketones each day. On the middle day (day 2) participants will also be asked to come into the lab to provide a blood sample at 2000 h.
The follow up visit will be identical to that performed before the fast, including meal testing, blood, muscle, and adipose samples.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Body mass index 20.0-29.9 kg∙m-2
- •Age 18-45 years
- •Willing to abstain from food intake for just over 3 days (~82 hours)
- •Able and willing to provide informed consent and safely comply with study procedures
- •Females to maintain record of regular menstrual cycle phase or contraceptive use
- •No anticipated changes in lifestyle during the study (e.g. holidays or exercise programmes)
排除标准
- •• Any reported condition or behaviour deemed either to pose undue personal risk to the participant or introduce bias
- •Any diagnosed metabolic disease (e.g. type 1 or type 2 diabetes)
- •Any reported use of substances which may pose undue personal risk to the participants or introduce bias into the experiment
- •Pregnancy
- •Breastfeeding
- •Lifestyle not conforming to standard sleep-wake cycle (e.g. shift worker)
- •History of eating disorders (e.g. anorexia)
- •Any reported recent (<6 months) change in body mass (± 3%)
- •Uncontrolled hyperthyroidism
- •Advanced cerebrovascular insufficiency or dementia
- •Advanced liver or kidney insufficiency
- •History of migraine and or headache
- •Psychotic disorders
- •Unstable or severe coronary artery disease
- •Retinal detachment
- •Duodenal or stomach ulcer
- •Cancer and malignant disease
- •Regular use of Non-steroidal anti-inflammatory drugs (NSAIDs)
- •Use of Systemic corticoids
- •Use of Antihypertensives (especially beta-blockers and diuretics)
- •Use of Antidiabetics
- •Use of Anti-coagulants
- •Use of Psychotropics (especially neuroleptics and lithium)
- •Use of Anticonvulsants.
研究组 & 干预措施
Prolonged Fasting
All participants are asked to act as their own control prior to being asked to undergo 3 days of fasting.
干预措施: Prolonged Fasting (Other)
结局指标
主要结局
Change in postprandial insulin responses
时间窗: 3 days
Change in postprandial insulin (mmol/L) response to a standardised meal before and after 3 days of fasting.
次要结局
- Change in plasma pyruvate(1 day, 2 days, 3 days)
- Change in body mass(1 day, 2 days, 3 days.)
- Change in amino acid metabolism(3 days.)
- Change in ketosis.(1 day, 2 days, 3 days.)
- Change in circulating glycerol and non-esterified fatty acids(1 day, 2 days, 3 days)
- Change in Autophagy(3 days)
- Change in plasma lactate(1 day, 2 days, 3 days)
- Change in postprandial glucose responses.(3 days.)
- Change in blood pressure(1 day, 2 days, 3 days.)
- Change in interstitial fluid glucose concentrations(1 day, 2 days, 3 days.)