Clinical trial NCT04924517: Extended Evening Fasting: Metabolic Health and Energy Balance
Official title: The Effect of 4 Days of Extended Evening Fasting on Metabolic Health, Energy Balance and Appetite
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Chrononutrition
Energy balance
Intermittent fasting
Appetite hormones
Lead sponsor: Nottingham Trent University
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study design is a randomised, controlled, crossover design in which participants undertake two conditions in a randomised order with at least four weeks in between trials.
Primary purpose: PREVENTION

Brief summary: This study will compare metabolic and feeding behaviour responses to 4 days of extended evening fasting vs. a control trial

Detailed description: Humans have evolved as a diurnal species, internally governed by the circadian system, which dictates our hormone regulation. 'Chrononutrition' is a sub-discipline which combines food timing with circadian physiology. The most popular method of time-restricted feeding in the UK is to skip breakfast. However, data from several meta-analysis have shown that skipping breakfast is associated with weight gain and insulin resistance, likely due to eating later into the evening/night and therefore, out of sync with our circadian rhythm. Recent research has shown that skipping dinner (evening fasting) has improved markers of cardio-metabolic health in clinical populations, although these are typically from longer-term studies. Despite these promising findings, it is not yet known whether these findings are population specific.

Therefore, the investigators are interested in examining the metabolic response pre and post intervention to see whether these promising findings can translate into a healthy population. Furthermore, the investigators will be monitoring subjective appetite, energy intake and expenditure to assess whether there is any short-term adaptation to a specific feeding window.

Eligibility criteria: Inclusion Criteria:

* Non-smokers.

  * Have maintained a stable weight for 6 months (self-reported).
  * No history of gastric, digestive, cardiovascular or renal disease (self reported).
  * Female specific: must be using a monophasic, low dose combined OCP (containing less than 50μg oestradiol and a synthetic progestin) OR females with regular menstrual cycles (self-reported).

Exclusion Criteria:

* Severe food allergies, dislike or intolerance of study foods or drinks.

  * Currently undergoing a lifestyle intervention (structured diet or exercise)
  * Diagnosis of a condition or currently undergoing treatment therapy known to affect glucose or lipid metabolism (e.g., type-2 diabetes, taking statins), or contraindications to exercise.
  * Use of medication or supplements that may affect hormone concentrations.
  * Excessive alcohol consumption (\>14 units/week).
  * Intensive training schedule (\>10 hours/week).
  * Female specific: currently pregnant or breastfeeding, the use of any hormonal contraception, and the self-reporting of short (\<24 d), long (\>35 d), or irregular menstrual cycles.

Primary outcomes:
measure: Glycaemic control (Baseline)
timeFrame: 3.5 hours following the standardised breakfast meal on day 1.
measure: Glycaemic control (Post intervention)
timeFrame: 3.5 hours following the standardised breakfast meal on day 4.
measure: Energy Intake (Kilocalories)
timeFrame: Day 1 to day 4.
measure: Energy expenditure
timeFrame: Day 1 to day 4.
Secondary outcomes:
measure: Cortisol awakening response
timeFrame: Five samples will be collected by the participant within the first hour of waking on day 5.
measure: Visual Analogue Scale for Subjective Ratings of Appetite
timeFrame: Every 2 hours between 8am-10pm from day 1 to day 4.
measure: Acylated Ghrelin (appetite hormone)
timeFrame: 3.5 hours following the standardised breakfast meal on day 1 and day 4.
measure: PYY (appetite hormone)
timeFrame: 3.5 hours following the standardised breakfast meal on day 1 and day 4.
measure: Carbohydrate oxidation
timeFrame: During laboratory visits on day 1 and day 4 [baseline, 60min, 120min, 180min]
measure: Fat oxidation
timeFrame: During laboratory visits on day 1 and day 4 [baseline, 60min, 120min, 180min]
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham Trent University
state: Greater London
Study officials:
References:
citation: Sutton EF, Beyl R, Early KS, Cefalu WT, Ravussin E, Peterson CM. Early Time-Restricted Feeding Improves Insulin Sensitivity, Blood Pressure, and Oxidative Stress Even without Weight Loss in Men with Prediabetes. Cell Metab. 2018 Jun 5;27(6):1212-1221.e3. doi: 10.1016/j.cmet.2018.04.010. Epub 2018 May 10.
citation: Jamshed H, Beyl RA, Della Manna DL, Yang ES, Ravussin E, Peterson CM. Early Time-Restricted Feeding Improves 24-Hour Glucose Levels and Affects Markers of the Circadian Clock, Aging, and Autophagy in Humans. Nutrients. 2019 May 30;11(6):1234. doi: 10.3390/nu11061234.
citation: Ravussin E, Beyl RA, Poggiogalle E, Hsia DS, Peterson CM. Early Time-Restricted Feeding Reduces Appetite and Increases Fat Oxidation But Does Not Affect Energy Expenditure in Humans. Obesity (Silver Spring). 2019 Aug;27(8):1244-1254. doi: 10.1002/oby.22518.
citation: Hutchison AT, Regmi P, Manoogian ENC, Fleischer JG, Wittert GA, Panda S, Heilbronn LK. Time-Restricted Feeding Improves Glucose Tolerance in Men at Risk for Type 2 Diabetes: A Randomized Crossover Trial. Obesity (Silver Spring). 2019 May;27(5):724-732. doi: 10.1002/oby.22449. Epub 2019 Apr 19.
citation: Templeman I, Gonzalez JT, Thompson D, Betts JA. The role of intermittent fasting and meal timing in weight management and metabolic health. Proc Nutr Soc. 2020 Feb;79(1):76-87. doi: 10.1017/S0029665119000636. Epub 2019 Apr 26.
citation: Popkin BM. The nutrition transition and obesity in the developing world. J Nutr. 2001 Mar;131(3):871S-873S. doi: 10.1093/jn/131.3.871S.
citation: Allison KC, Goel N. Timing of eating in adults across the weight spectrum: Metabolic factors and potential circadian mechanisms. Physiol Behav. 2018 Aug 1;192:158-166. doi: 10.1016/j.physbeh.2018.02.047. Epub 2018 Feb 24.
citation: St-Onge MP, Ard J, Baskin ML, Chiuve SE, Johnson HM, Kris-Etherton P, Varady K; American Heart Association Obesity Committee of the Council on Lifestyle and Cardiometabolic Health; Council on Cardiovascular Disease in the Young; Council on Clinical Cardiology; and Stroke Council. Meal Timing and Frequency: Implications for Cardiovascular Disease Prevention: A Scientific Statement From the American Heart Association. Circulation. 2017 Feb 28;135(9):e96-e121. doi: 10.1161/CIR.0000000000000476. Epub 2017 Jan 30.