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Trial record 36 of 399 for:    PYY

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

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.


Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Maltodextrin (carbohydrate) Other: Exercise Other: Rest Other: Water Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
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
Official Title: Carbohydrate Intake and Gut Hormone Release During Exercise
Actual Study Start Date : February 21, 2019
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: No Carbohydrate Drink + Rest
Participants will consume the no carbohydrate drink (300ml water) followed by a rest session
Other: Rest
30 minutes laying on a bed

Other: Water
A drink containing 300ml of 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)
Other: Exercise
30 minutes on a cycle ergometer working at 75% VO2 max

Other: Water
A drink containing 300ml of water

Active Comparator: Carbohydrate Drink + Rest
Participants will consume the carbohydrate drink (300ml water + 75g maltodextrin) followed by a rest session
Dietary Supplement: Maltodextrin (carbohydrate)
A drink containing 300ml of water and 75g of maltodextrin

Other: Rest
30 minutes laying on a bed

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)
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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. 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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04019418


Contacts
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Contact: James Frampton, MRes 07807089931 j.frampton17@imperial.ac.uk

Locations
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United Kingdom
Imperial Clinical Research Facility Recruiting
London, United Kingdom, W12 0HS
Contact: Karen Mosley, PhD    020 3313 8073    k.mosley@nhs.net   
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Edward Chambers, PhD Imperial College London

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT04019418     History of Changes
Other Study ID Numbers: 18HH4889
First Posted: July 15, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No: There is not a plan to make IPD available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Imperial College London:
carbohydrate
exercise
PYY
GLP-1
ghrelin
hormones

Additional relevant MeSH terms:
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Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs