Obesity Clinical Trial
Official title:
Comparing the Effects of a High- and Low-carbohydrate Pre-exercise Meal Relative to Fasting on Exercise Metabolism, Subsequent Appetite, and Energy Intake in Healthy Males.
Verified date | September 2022 |
Source | Nottingham Trent University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will compare the metabolic, appetite, energy intake, and perceptual responses to a bout of exercise completed in the evening after after a low-carbohydrate lunch meal (<10% carbohydrate content / 0.2 g/kg carbohydrate; LO-CHO), with the responses to exercise performed after a lunch meal containing a high carbohydrate content (~60% carbohydrate content / 2.2 g/kg carbohydrate; HI-CHO), and after skipping lunch and fasting for 8 hours since breakfast (FAST).
Status | Completed |
Enrollment | 12 |
Est. completion date | June 30, 2022 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: 1. Non-smokers (due to the well-known impact of smoking on appetite. 2. Not currently on a weight management program or have an unusual eating pattern (i.e., extended fasting periods >8 h other than overnight). 3. Have maintained a stable weight for 6 months (self-reported). 4. No history of gastric, digestive, cardiovascular or renal disease (self-reported). Exclusion Criteria: 1. Severe food allergies, dislike or intolerance of study foods or drinks. 2. Currently undergoing a lifestyle intervention (structured diet or exercise). 3. 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. 4. Use of medication or supplements that may affect hormone concentrations and/or substrate metabolism. 5. Excessive alcohol consumption (>14 units/week). 6. Intensive training schedule (>10 hours/week). |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Loughborough University | Loughborough | Leicestershire |
United Kingdom | Nottingham Trent University | Nottingham | Nottinghamshire |
Lead Sponsor | Collaborator |
---|---|
Nottingham Trent University | Loughborough University |
United Kingdom,
Bachman JL, Deitrick RW, Hillman AR. Exercising in the Fasted State Reduced 24-Hour Energy Intake in Active Male Adults. J Nutr Metab. 2016;2016:1984198. Epub 2016 Sep 21. — View Citation
Edinburgh RM, Bradley HE, Abdullah NF, Robinson SL, Chrzanowski-Smith OJ, Walhin JP, Joanisse S, Manolopoulos KN, Philp A, Hengist A, Chabowski A, Brodsky FM, Koumanov F, Betts JA, Thompson D, Wallis GA, Gonzalez JT. Lipid Metabolism Links Nutrient-Exercise Timing to Insulin Sensitivity in Men Classified as Overweight or Obese. J Clin Endocrinol Metab. 2020 Mar 1;105(3). pii: dgz104. doi: 10.1210/clinem/dgz104. — View Citation
Edinburgh RM, Hengist A, Smith HA, Travers RL, Betts JA, Thompson D, Walhin JP, Wallis GA, Hamilton DL, Stevenson EJ, Tipton KD, Gonzalez JT. Skipping Breakfast Before Exercise Creates a More Negative 24-hour Energy Balance: A Randomized Controlled Trial in Healthy Physically Active Young Men. J Nutr. 2019 Aug 1;149(8):1326-1334. doi: 10.1093/jn/nxz018. — View Citation
Kendzierski, D., & DeCarlo, K. J. (1991). Physical Activity Enjoyment Scale: Two Validation Studies. Journal of Sport and Exercise Psychology, 13(1), 50-64. doi:10.1123/jsep.13.1.50.
Oliveira CLP, Boulé NG, Berg A, Sharma AM, Elliott SA, Siervo M, Ghosh S, Prado CM. Consumption of a High-Protein Meal Replacement Leads to Higher Fat Oxidation, Suppression of Hunger, and Improved Metabolic Profile After an Exercise Session. Nutrients. 2021 Jan 5;13(1). pii: E155. doi: 10.3390/nu13010155. — View Citation
Rothschild JA, Kilding AE, Broome SC, Stewart T, Cronin JB, Plews DJ. Pre-Exercise Carbohydrate or Protein Ingestion Influences Substrate Oxidation but Not Performance or Hunger Compared with Cycling in the Fasted State. Nutrients. 2021 Apr 14;13(4). pii: 1291. doi: 10.3390/nu13041291. — View Citation
Rowlands DS, Hopkins WG. Effects of high-fat and high-carbohydrate diets on metabolism and performance in cycling. Metabolism. 2002 Jun;51(6):678-90. — View Citation
Van Proeyen K, Szlufcik K, Nielens H, Pelgrim K, Deldicque L, Hesselink M, Van Veldhoven PP, Hespel P. Training in the fasted state improves glucose tolerance during fat-rich diet. J Physiol. 2010 Nov 1;588(Pt 21):4289-302. doi: 10.1113/jphysiol.2010.196493. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fat Oxidation Rate During Steady-State Exercise. | Measurements of VO2 and VCO2 during a 60 minute steady state bout of cycling to determine rates of fat oxidation. | Throughout the 60-minute steady-state bout of cycling | |
Secondary | Voluntary energy intake (Kilocalories) at a laboratory-based test meal. | A laboratory-based dinner 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'. | 60 minutes following the end 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, 1 hour, 1.75 hours, 2.75 hours, 3 hours, 3.5 hours (mid-exercise), 4 hours, 5 hours. | |
Secondary | Acylated ghrelin | Time-course of acylated ghrelin plasma concentrations across experimental trials. | Baseline, 1 hour, 1.75 hours, 2.75 hours, 3 hours, 3.5 hours (mid-exercise), 4 hours, 5 hours. | |
Secondary | Peptide tyrosine-tyrosine (PYY) | Time-course of PYY plasma concentrations across experimental trials. | Baseline, 1 hour, 1.75 hours, 2.75 hours, 3 hours, 3.5 hours (mid-exercise), 4 hours, 5 hours. | |
Secondary | Glucagon-like peptide-1 (GLP-1) | Time-course of GLP-1 plasma concentrations across experimental trials. | Baseline, 1 hour, 1.75 hours, 2.75 hours, 3 hours, 3.5 hours (mid-exercise), 4 hours, 5 hours. | |
Secondary | Glucose | Time-course of glucose plasma concentrations across experimental trials. | Baseline, 1 hour, 1.75 hours, 2.75 hours, 3 hours, 3.5 hours (mid-exercise), 4 hours, 5 hours. | |
Secondary | Insulin | Time-course of insulin plasma concentrations across experimental trials. | Baseline, 1 hour, 1.75 hours, 2.75 hours, 3 hours, 3.5 hours (mid-exercise), 4 hours, 5 hours. | |
Secondary | Non-esterified fatty-acids (NEFA) | Time-course of NEFA plasma concentrations across experimental trials. | Baseline, 1 hour, 1.75 hours, 2.75 hours, 3 hours, 3.5 hours (mid-exercise), 4 hours, 5 hours. | |
Secondary | Glycerol | Time-course of glycerol plasma concentrations across experimental trials. | Baseline, 1 hour, 1.75 hours, 2.75 hours, 3 hours, 3.5 hours (mid-exercise), 4 hours, 5 hours. | |
Secondary | Rating of Perceived Exertion (RPE). | RPE will be measured at 10-minute intervals throughout the 60-minute exercise period 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). | Throughout the 60-minute steady-state bout of cycling. | |
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. | |
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 | Carbohydrate Oxidation Rate During Steady-State Exercise | Measurements of VO2 and VCO2 during a 60 minute steady state bout of cycling to determine rates of carbohydrate oxidation | Throughout the 60-minute steady-state bout of cycling | |
Secondary | Rate of Energy Expenditure During Steady-State Exercise | Measurements of VO2 and VCO2 during a 60 minute steady state bout of cycling to determine rates energy expenditure. | Throughout the 60-minute steady-state bout of cycling | |
Secondary | Carbohydrate Oxidation Rate At Rest | Measurements of VO2 and VCO2 during at rest during experimental trials to determine rates of carbohydrate oxidation. | Baseline, 1 hour, 1.75 hours, 2.75 hours, 5 hours | |
Secondary | Fat Oxidation Rate At Rest | Measurements of VO2 and VCO2 during at rest during experimental trials to determine rates of fat oxidation. | Baseline, 1 hour, 1.75 hours, 2.75 hours, 5 hours | |
Secondary | Rate of Energy Expenditure At Rest | Measurements of VO2 and VCO2 during at rest during experimental trials to determine rates of energy expenditure. | Baseline, 1 hour, 1.75 hours, 2.75 hours, 5 hours |
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