Extended Evening Fasting: Metabolic Health and Energy Balance

Not Applicable

• Conditions: Obesity
• Interventions: Behavioral: Control; Behavioral: Extended Evening Fasting

• Registration Number: NCT04924517
• Lead Sponsor: Nottingham Trent University

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.

Study Timeline

• Study First Submitted: 2021-05-24
• Study First Submitted QC: 2021-06-10
• Study First Posted: 2021-06-14
• Study Start: 2021-09-14
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-16
• Last Update Posted: 2022-03-31
• Primary Completion: 2022-06-14
• Study Completion: 2022-06-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control	Control	Participants will eat between 8am-8pm
Extended Evening Fasting	Extended Evening Fasting	Participants will eat between 8am-4pm

Primary Outcome Measures

Name	Time	Method
Glycaemic control (Post intervention)	3.5 hours following the standardised breakfast meal on day 4.	A metabolic assessment lasting 3.5 hours will take place following a standardised, laboratory-based meal. The investigators will be taking periodic capillary and venous blood samples to measure post-prandial glucose and insulin, which together comprise 'glycaemic control'.
Glycaemic control (Baseline)	3.5 hours following the standardised breakfast meal on day 1.	A metabolic assessment lasting 3.5 hours will take place following a standardised, laboratory-based meal. The investigators will be taking periodic capillary and venous blood samples to measure post-prandial glucose and insulin, which together comprise 'glycaemic control'.
Energy Intake (Kilocalories)	Day 1 to day 4.	Energy intake will be measured both during lab and outside of the laboratory when the participants are free-living. During lab, energy intake will be measured through ad-libitum feeding buffet where 20 minutes will be permitted to eat as much or as little as they desire, until 'comfortably full and satisfied', followed by post-feeding measurement of the remaining food. Outside of laboratory feeding will also be monitored through food diary's and weighing any investigator issued meals.
Energy expenditure	Day 1 to day 4.	Energy expenditure will be measured via a chest-worn device (Actiheart) which combines heart rate and accelerometry to gauge calories expended.

Secondary Outcome Measures

Name	Time	Method
Cortisol awakening response	Five samples will be collected by the participant within the first hour of waking on day 5.	The cortisol awakening response will be measured on the final morning of each trial.
Visual Analogue Scale for Subjective Ratings of Appetite	Every 2 hours between 8am-10pm from day 1 to day 4.	Subjective appetite will be measured on mobile devices via a software which replicates a 100mm visual analogue scale. The scale is divided into subscales of different appetite perceptions including: hunger, fullness, desire to eat and prospective food consumption.; (i.e. from 0 - 100), with a rating of 100 fully supporting the perception and a rating of 0 fully opposing the perception.
PYY (appetite hormone)	3.5 hours following the standardised breakfast meal on day 1 and day 4.	PYY will be measured from the venous samples taken during the post-prandial period following the standardised meal.
Carbohydrate oxidation	During laboratory visits on day 1 and day 4 [baseline, 60min, 120min, 180min]	Investigators will be collecting expired air into Douglas bags, and measuring the VO2 and VCO2 concentration to calculate carbohydrate oxidation.
Fat oxidation	During laboratory visits on day 1 and day 4 [baseline, 60min, 120min, 180min]	Investigators will be collecting expired air into Douglas bags, and measuring the VO2 and VCO2 concentration to calculate fat oxidation.
Acylated Ghrelin (appetite hormone)	3.5 hours following the standardised breakfast meal on day 1 and day 4.	Acylated Ghrelin will be measured from the venous samples taken during the post-prandial period following the standardised meal.

Trial Locations

Locations (1)

Nottingham Trent University; 🇬🇧 Nottingham, Greater London, United Kingdom