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Carbohydrate Intake and Gut Hormone Release During Exercise

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ClinicalTrials.gov Identifier: NCT04019418
Recruitment Status : Recruiting
First Posted : July 15, 2019
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Tracking Information
First Submitted Date  ICMJE July 9, 2019
First Posted Date  ICMJE July 15, 2019
Last Update Posted Date July 17, 2019
Actual Study Start Date  ICMJE February 21, 2019
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2019)
  • Changes in GLP-1 concentration [ Time Frame: During the study visit, 165 minutes ]
    Changes in GLP-1 concentration between exercise and resting conditions, and between carbohydrate and control conditions
  • Changes in PYY concentration [ Time Frame: During the study visit, 165 minutes ]
    Changes in PYY concentration between exercise and resting conditions, and between carbohydrate and control conditions
  • Changes in acylated ghrelin concentration [ Time Frame: During the study visit, 165 minutes ]
    Changes in acylated ghrelin concentration between exercise and resting conditions, and between carbohydrate and control conditions
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04019418 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2019)
  • Changes in energy intake [ Time Frame: During the study visit, 165 minutes ]
    Differences in energy intake at an ad libitum meal between exercise and resting conditions, and between carbohydrate and control conditions
  • Changes in Energy expenditure [ Time Frame: During the study visit, 165 minutes ]
    Differences in energy expenditure between exercise and resting conditions, and between carbohydrate and control conditions.
  • Changes in energy balance [ Time Frame: During the study visit, 165 minutes ]
    Differences in energy balance between exercise and resting conditions, and between carbohydrate and control conditions.
  • Changes in Catecholamines concentration [ Time Frame: During the study visit, 165 minutes ]
    Changes in catecholamine concentrations between exercise and resting conditions, and between carbohydrate and control conditions
  • Glucose homeostasis [ Time Frame: During the study visit, 165 minutes ]
    Changes in glucose homeostasis between exercise and resting conditions, and between carbohydrate and control conditions.
  • Changes in subjective nausea [ Time Frame: During the study visit, 165 minutes ]
    Changes in subjective feelings of nausea as measured by visual analogue scales between exercise and resting conditions, and between carbohydrate and control conditions. Visual analogue scales will range from 0 mm to 100 mm with a higher score indicating a higher degree of nausea.
  • Changes in subjective appetite [ Time Frame: During the study visit, 165 minutes ]
    Changes in subjective feelings of appetite as measured by visual analogue scales between exercise and resting conditions, and between carbohydrate and control conditions. Visual analogue scales will range from 0 mm to 100 mm with a higher score indicating a higher degree of fullness.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2019)
  • Changes in energy intake [ Time Frame: During the study visit, 165 minutes ]
    Differences in energy intake at an ad libitum meal between exercise and resting conditions, and between carbohydrate and control conditions
  • Changes in Energy expenditure [ Time Frame: During the study visit, 165 minutes ]
    Differences in energy expenditure between exercise and resting conditions, and between carbohydrate and control conditions.
  • Changes in energy balance [ Time Frame: During the study visit, 165 minutes ]
    Differences in energy balance between exercise and resting conditions, and between carbohydrate and control conditions.
  • Changes in Catecholamines concentration [ Time Frame: During the study visit, 165 minutes ]
    Changes in catecholamine concentrations between exercise and resting conditions, and between carbohydrate and control conditions
  • Glucose homeostasis [ Time Frame: During the study visit, 165 minutes ]
    Changes in glucose homeostasis between exercise and resting conditions, and between carbohydrate and control conditions.
  • Changes in subjective nausea [ Time Frame: During the study visit, 165 minutes ]
    Changes in subjective feelings of nausea as measured by visual analogue scales between exercise and resting conditions, and between carbohydrate and control conditions.
  • Changes in subjective appetite [ Time Frame: During the study visit, 165 minutes ]
    Changes in subjective feelings of appetite as measured by visual analoguie scales between exercise and resting conditions, and between carbohydrate and control conditions.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Carbohydrate Intake and Gut Hormone Release During Exercise
Official Title  ICMJE Carbohydrate Intake and Gut Hormone Release During Exercise
Brief Summary

It is well known that following a single session of moderate-to-high intensity exercise individuals experience a temporary suppression of hunger and a delay in the commencement of eating. This effect is believed to be due to changes in blood concentrations of specific hormones released from the gut that influence appetite.

Individuals undertaking physical activity often consume foods immediately before exercise in order to improve their performance. However, it is currently unknown whether this eating practice influences the gut hormone response to exercise as well as how hungry an individual feels post-exercise.

Therefore, the aim of this study is to investigate the effect of consuming a sugary (carbohydrate) drink immediately before starting an exercise session on the concentration of these gut hormones as well as the amount of food eaten in the hours following exercise completion.

Detailed Description

It is well established that following an acute bout of moderate-to-high intensity exercise individuals experience a transient suppression of hunger and a delay in the commencement of eating - a phenomenon referred to as exercise-induced anorexia. Acute exercise modulates the concentrations of gut hormones known to influence satiety, including the anorexigenic hormones glucagon-like peptide 1 (GLP-1) and peptide tyrosine tyrosine (PYY), as well as the acylated form of the orexigenic hormone ghrelin. These alterations in gut hormone concentrations have consequently been hypothesised to play a key role in exercise-induced anorexia.

Despite suppressing hunger and delaying eating, acute exercise does not appear to alter short-term energy intake in the immediate hours following exercise completion. The absence of a compensatory response therefore creates an energy deficit capable of inducing weight loss. Strategies that augment the gut hormone response to acute exercise may thus increase the potency of exercise as a weight-loss tool.

Research investigating the effect of exercise on appetite has frequently utilised participants in a fasting state. Undertaking exercise in this physiological condition contradicts current practices, as athletes often consume a carbohydrate source immediately prior to exercise in an attempt to maximise performance. It is currently unknown as to whether the consumption of carbohydrate during this period may further enhance the gut hormone response to exercise, and thus research into a potential additive effect is warranted.

High-intensity exercise increases sympathetic nervous system activity and catecholamine release. Catecholamine concentrations are negatively correlated with acylated ghrelin concentrations and may directly stimulate GLP-1 and PYY release via activation of β-receptors located on L-cells. The decrease in gastric emptying rate that is observed during high-intensity exercise is also attributed to this increase in sympathetic activity. Consequently, an increase in sympathetic nervous system activity has been postulated as a key mechanism underlying exercise-induced changes in gut hormone concentrations. However, to our knowledge, no study has directly measured the relationship between sympathetic nervous system activity and anorexigenic gut hormone release during exercise.

Therefore, the aim of this study is to examine any potential additive effects of carbohydrate ingestion immediately prior to exercise on gut hormone release and post-exercise appetite suppression. Furthermore, this study will look to investigate the mechanisms underlying changes in gut hormone concentrations experienced during exercise.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Participants perform all four trials in a randomized order
Masking: Double (Participant, Investigator)
Masking Description:
Participants and investigators will be masked to the contents of the beverage. They will not be masked to whether it is a resting or exercise condition as this is not possible.
Primary Purpose: Basic Science
Condition  ICMJE Obesity
Intervention  ICMJE
  • Dietary Supplement: Maltodextrin (carbohydrate)
    A drink containing 300ml of water and 75g of maltodextrin
  • Other: Exercise
    30 minutes on a cycle ergometer working at 75% VO2 max
  • Other: Rest
    30 minutes laying on a bed
  • Other: Water
    A drink containing 300ml of water
Study Arms  ICMJE
  • Placebo Comparator: No Carbohydrate Drink + Rest
    Participants will consume the no carbohydrate drink (300ml water) followed by a rest session
    Interventions:
    • Other: Rest
    • Other: Water
  • Active Comparator: No Carbohydrate Drink + Exercise
    Participants will consume the no carbohydrate drink (300ml water) followed by an exercise session (75% VO2 max on a cycle ergometer)
    Interventions:
    • Other: Exercise
    • Other: Water
  • Active Comparator: Carbohydrate Drink + Rest
    Participants will consume the carbohydrate drink (300ml water + 75g maltodextrin) followed by a rest session
    Interventions:
    • Dietary Supplement: Maltodextrin (carbohydrate)
    • Other: Rest
  • Experimental: Carbohydrate Drink + Exercise
    Participants will consume the carbohydrate drink (300ml water + 75g maltodextrin) followed by an exercise session (75% VO2 max on a cycle ergometer)
    Interventions:
    • Dietary Supplement: Maltodextrin (carbohydrate)
    • Other: Exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 12, 2019)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male
  • Age between 18-40 years (inclusive)
  • Body mass index (BMI) of 18-30 kg/m2
  • Willingness and ability to give written informed consent and willingness and ability to understand, to participate and to comply with the study requirements

Exclusion Criteria:

  • Abnormal ECG
  • Screening blood results outside of normal reference values
  • Current smokers
  • Current or history of substance abuse and/or excess alcohol intake
  • Diabetes
  • Cardiovascular disease
  • Cancer
  • Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome
  • Kidney disease
  • Liver disease
  • Pancreatitis
  • Started new medication within the last 3 months likely to interfere with energy metabolism, appetite regulation and hormonal balance, including: anti-inflammatory drugs or steroids, antibiotics, androgens, phenytoin, erythromycin or thyroid hormones.
  • Participation in a research study in the 12 week period prior to entering this study.
  • Any blood donation within the 12 week period prior to entering this study
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Male
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: James Frampton, MRes 07807089931 j.frampton17@imperial.ac.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04019418
Other Study ID Numbers  ICMJE 18HH4889
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No: There is not a plan to make IPD available
Responsible Party Imperial College London
Study Sponsor  ICMJE Imperial College London
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Edward Chambers, PhD Imperial College London
PRS Account Imperial College London
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP