Obesity Clinical Trial
Official title:
Effects of Extended Fasting Prior to Evening Exercise on Appetite, Energy Intake and Performance.
| Verified date | August 2021 |
| Source | Nottingham Trent University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 16 |
| Est. completion date | June 23, 2021 |
| Est. primary completion date | June 23, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 40 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Loughborough University | Loughborough | |
| United Kingdom | Nottingham Trent University | Nottingham |
| Lead Sponsor | Collaborator |
|---|---|
| Nottingham Trent University | Loughborough University |
United Kingdom,
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McIver VJ, Mattin LR, Evans GH, Yau AMW. Diurnal influences of fasted and non-fasted brisk walking on gastric emptying rate, metabolic responses, and appetite in healthy males. Appetite. 2019 Dec 1;143:104411. doi: 10.1016/j.appet.2019.104411. Epub 2019 Aug 21. — View Citation
Metcalfe RS, Thomas M, Lamb C, Chowdhury EA. Omission of a carbohydrate-rich breakfast impairs evening endurance exercise performance despite complete dietary compensation at lunch. Eur J Sport Sci. 2021 Jul;21(7):1013-1021. doi: 10.1080/17461391.2020.1797890. Epub 2020 Aug 27. — View Citation
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Voluntary energy intake (Kilocalories) at a laboratory-based test meal | A laboratory-based meal consisting of pasta, tomato sauce and olive oil will be provided to participants in excess of expected consumption. Participants will be permitted 20 minutes to eat as much or as little as they desire, until 'comfortably full and satisfied'. | 15 minutes following the end of the exercise session. | |
| Primary | Exercise Performance (Voluntary Energy Expenditure) | Maximum energy expenditure (Kilojoules) that can be completed within 15 minutes on a stationary bicycle ergometer. The participant will be able to alter their power output by selecting up or down on the ergometer control unit as they please. | Within the 15-minute performance test component of the exercise session. | |
| Secondary | Visual Analogue Scale for Subjective Ratings of Appetite | Time-course of subjective ratings of hunger between breakfast provision and one hour after consuming lunch, measured using an appetite visual analogue scale. The scale is divided into subscales of different appetite perceptions including: hunger, fullness, desire to eat and prospective food consumption. Each subscale is rated on a 100mm scale (i.e. from 0 - 100), with a rating of 100 fully supporting the perception and a rating of 0 fully opposing the perception. | 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. | |
| Secondary | Substrate Utilisation During Steady State Exercise. | Measurements of VO2 and VCO2 during a 30 minute steady state bout of cycling which precedes the 15-minute performance test. | Within the 30-minute steady-state component of the exercise session. | |
| Secondary | Rating of Perceived Exertion (RPE). | RPE will be measured at 5-minute intervals throughout the 45-minute exercise period (30 min steady state; 15 min performance test) on a 6-20 RPE scale. The participant will point to the value that corresponds to their current perceived exertion (6 being no exertion at all; 20 being maximal exertion). | Within the 45-minute exercise session. | |
| Secondary | Enjoyment of the Exercise Bout | A shortened version of The Physical Activity Enjoyment Scale (PACES) will be completed to gauge enjoyment of the exercise sessions. A scale from 1-7 will be used for eight feelings. The participant will circle the value that corresponds to which (6 being no exertion at all; 20 being maximal exertion).
The scale is divided into bipolar subscales of different feelings including: enjoyment, liking, pleasure, fun, pleasantness, interest, engagement and task absorption . Each subscale is rated on a 1-7 bipolar scale (i.e. from 1 - 7), with a rating of 1 fully supporting the feeling on the left-hand side of the subscale, and a rating of 7 fully supporting the feeling on the right-hand side of the subscale. For three subscales, a positive feeling is placed at 7, and for four subscales, a negative feeling is placed at 7 (reverse scored). |
Immediately following the end of the exercise session. | |
| Secondary | Pre-exercise Subjective Feelings | A single questionnaire to assess pre-exercise subjective feelings will be measured using a visual analogue scale. The scale is divided into subscales of different feelings including: motivation, readiness, tiredness, nausea, and energetic. Each subscale is rated on a 100mm scale (i.e. from 0 - 100), with a rating of 100 fully supporting the perception and a rating of 0 fully opposing the perception. | Immediately before the exercise session. |
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