Clinical trial NCT04742530: Fasted Evening Exercise: Performance and Compensatory Eating
Official title: Effects of Extended Fasting Prior to Evening Exercise on Appetite, Energy Intake and Performance.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Fasted exercise
Energy intake
Energy balance
Appetite
Exercise performance
Lead sponsor: Nottingham Trent University
Sponsor class: OTHER
Collaborators: name: Loughborough University
First posted: 2021-02-08
Enrollment: 16
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 three exercise conditions in a randomised order with at least a seven day period in between trials.
Primary purpose: BASIC_SCIENCE

Brief summary: This study will compare the appetite, energy intake, and exercise performance responses to a bout of exercise completed in the evening after an extended period of fasting with a similar bout of exercise completed in the evening and the morning, after consuming a carbohydrate-containing meal.

Detailed description: Regular exercise is known to be a successful strategy for improving several facets of health and maintaining body weight. However, many people are not engaging in enough exercise, and some may not be achieving maximum benefits from the exercise that they already do. Performing exercise in the overnight fasted state has been shown to reduce energy intake over the course of a single day, without any compensatory reductions in free-living energy expenditure. Despite these promising findings, it is likely that not every member of the population is logistically able to perform exercise in the morning due to various work, family and social commitments, and exercise in the evening may be a logical alternative for these individuals. Whether the beneficial effects of overnight fasted exercise can be observed at an alternative time of the day (i.e. the evening) is unknown.

Therefore, the investigators are interested in examining the compensatory appetite and energy intake responses following a bout of evening exercise performed after an extended (7 hour) period of fasting. Exercise performance will also be assessed as a marker of voluntary energy expenditure, which if reduced, has the potential to compensate for the reduced energy balance induced by fasted exercise.

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:

* Have an unusual eating pattern (i.e., extended fasting periods \>8h other than overnight - self-reported).
* 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).
* Having received a positive COVID-19 test in the 6-month period prior to participation.
* 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: Voluntary energy intake (Kilocalories) at a laboratory-based test meal
timeFrame: 15 minutes following the end of the exercise session.
measure: Exercise Performance (Voluntary Energy Expenditure)
timeFrame: Within the 15-minute performance test component of the exercise session.
Secondary outcomes:
measure: Visual Analogue Scale for Subjective Ratings of Appetite
timeFrame: Baseline, 2 hours, 3 hours, 3.5 hours, 5 hours, 7 hours, 8 hours, 10 hours, 11 hours, 12 hours, 14 hours, and 24 hours.
measure: Substrate Utilisation During Steady State Exercise.
timeFrame: Within the 30-minute steady-state component of the exercise session.
measure: Rating of Perceived Exertion (RPE).
timeFrame: Within the 45-minute exercise session.
measure: Enjoyment of the Exercise Bout
timeFrame: Immediately following the end of the exercise session.
measure: Pre-exercise Subjective Feelings
timeFrame: Immediately before the exercise session.
Other outcomes:
Locations:
city: Loughborough
country: United Kingdom
facility: Loughborough University
city: Nottingham
country: United Kingdom
facility: Nottingham Trent University
Study officials:
References:
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