NCT04019418

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 15, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2020

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

12 months

First QC Date

July 9, 2019

Last Update Submit

August 7, 2024

Conditions

Keywords

carbohydrateexercisePYYGLP-1ghrelinhormones

Outcome Measures

Primary Outcomes (3)

  • Changes in GLP-1 concentration

    Changes in GLP-1 concentration between exercise and resting conditions, and between carbohydrate and control conditions

    During the study visit, 165 minutes

  • Changes in PYY concentration

    Changes in PYY concentration between exercise and resting conditions, and between carbohydrate and control conditions

    During the study visit, 165 minutes

  • Changes in acylated ghrelin concentration

    Changes in acylated ghrelin concentration between exercise and resting conditions, and between carbohydrate and control conditions

    During the study visit, 165 minutes

Secondary Outcomes (6)

  • Changes in energy intake

    During the study visit, 165 minutes

  • Changes in Energy expenditure

    During the study visit, 165 minutes

  • Changes in energy balance

    During the study visit, 165 minutes

  • Glucose homeostasis

    During the study visit, 165 minutes

  • Changes in subjective nausea

    During the study visit, 165 minutes

  • +1 more secondary outcomes

Study Arms (4)

No Carbohydrate Drink + Rest

PLACEBO COMPARATOR

Participants will consume the no carbohydrate drink (300ml water) followed by a rest session

Other: RestOther: Water

No Carbohydrate Drink + Exercise

ACTIVE COMPARATOR

Participants will consume the no carbohydrate drink (300ml water) followed by an exercise session (75% VO2 max on a cycle ergometer)

Other: ExerciseOther: Water

Carbohydrate Drink + Rest

ACTIVE COMPARATOR

Participants will consume the carbohydrate drink (300ml water + 75g maltodextrin) followed by a rest session

Dietary Supplement: Maltodextrin (carbohydrate)Other: Rest

Carbohydrate Drink + Exercise

EXPERIMENTAL

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)Other: Exercise

Interventions

Maltodextrin (carbohydrate)DIETARY_SUPPLEMENT

A drink containing 300ml of water and 75g of maltodextrin

Carbohydrate Drink + ExerciseCarbohydrate Drink + Rest

30 minutes on a cycle ergometer working at 75% VO2 max

Carbohydrate Drink + ExerciseNo Carbohydrate Drink + Exercise
RestOTHER

30 minutes laying on a bed

Carbohydrate Drink + RestNo Carbohydrate Drink + Rest
WaterOTHER

A drink containing 300ml of water

No Carbohydrate Drink + ExerciseNo Carbohydrate Drink + Rest

Eligibility Criteria

Age18 Years - 40 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial Clinical Research Facility

London, W12 0HS, United Kingdom

Location

Related Publications (1)

  • Frampton J, Serrano-Contreras JI, Garcia-Perez I, Franco-Becker G, Penhaligan J, Tan ASY, de Oliveira ACC, Milner AJ, Murphy KG, Frost G, Chambers ES. The metabolic interplay between dietary carbohydrate and exercise and its role in acute appetite regulation in males: a randomized controlled study. J Physiol. 2023 Aug;601(16):3461-3480. doi: 10.1113/JP284294. Epub 2023 Jun 15.

MeSH Terms

Conditions

ObesityMotor Activity

Interventions

maltodextrinCarbohydratesExerciseRE1-silencing transcription factorWater

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Edward Chambers, PhD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
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.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Participants perform all four trials in a randomized order
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2019

First Posted

July 15, 2019

Study Start

February 21, 2019

Primary Completion

February 12, 2020

Study Completion

February 12, 2020

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

No: There is not a plan to make IPD available

Locations