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Clinical Trials/NCT04924517
NCT04924517
Unknown
Not Applicable

The Effect of 4 Days of Extended Evening Fasting on Metabolic Health, Energy Balance and Appetite

Nottingham Trent University1 site in 1 country12 target enrollmentSeptember 14, 2021
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Nottingham Trent University
Enrollment
12
Locations
1
Primary Endpoint
Glycaemic control (Post intervention)
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 14, 2021
End Date
June 14, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

William Mode

Principle Investigator

Nottingham Trent University

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.

Outcomes

Primary Outcomes

Glycaemic control (Post intervention)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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

Time Frame: 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 Outcomes

  • Cortisol awakening response(Five samples will be collected by the participant within the first hour of waking on day 5.)
  • Visual Analogue Scale for Subjective Ratings of Appetite(Every 2 hours between 8am-10pm from day 1 to day 4.)
  • PYY (appetite hormone)(3.5 hours following the standardised breakfast meal on day 1 and day 4.)
  • Carbohydrate oxidation(During laboratory visits on day 1 and day 4 [baseline, 60min, 120min, 180min])
  • Fat oxidation(During laboratory visits on day 1 and day 4 [baseline, 60min, 120min, 180min])
  • Acylated Ghrelin (appetite hormone)(3.5 hours following the standardised breakfast meal on day 1 and day 4.)

Study Sites (1)

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