- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06849050
The Influence of Acute Continuous Exercise and Adiposity on Appetite Hormones and Neural Correlates of Visual Food Cues (ACECRAVE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Single bouts of exercise transiently suppress appetite and the orexigenic gut hormone acylated ghrelin and increase anorexigenic gut hormone concentrations including peptide YY (PYY) and glucagon-like peptide-1 (GLP-1). These changes occur without stimulating compensatory increases in appetite and energy intake on the day of exercise resulting in a short-term energy deficit. Oxyntomodulin is another gut-derived hormone that suppresses appetite and increases energy expenditure but the influence of acute exercise on oxyntomodulin concentrations in individuals varying in adiposity status has not been investigated. This study will investigate whether acute continuous walking/jogging impacts circulating oxyntomodulin concentrations in individuals who are lean or living with overweight or obesity. The influence of exercise and adiposity on other hormonal, subjective, sensory and neural correlates of appetite will also be explored.
This study is a cross-over design consisting of four visits: a pre-visit, two main trial visits (exercise and control) and a magnetic resonance imaging (MRI) visit. Participants will undertake a preliminary measures visit (pre-visit) to confirm eligibility, complete questionnaires assessing their health, habitual physical activity and eating behaviours, undergo standard anthropometric measurements (height, weight, and hip/waist circumference) and treadmill exercise tests to determine their peak oxygen uptake.
Main trials will be separated by at least seven days for male participants, whereas female participants will complete the two main trials in the follicular phase (the first seven days) of the menstrual cycle. Participants will arrive at the laboratory after fasting overnight for at least 10 hours (plain water is permitted). Participants will then complete assessments of height, weight and either bioelectrical impedance analysis (main trial 1) or air displacement plethysmography (BOD POD®) (main trial 2). A venous cannula will be inserted for the collection of venous blood samples at 30-minute intervals (0 hours [08:30], 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours and 4 hours). Subjective appetite ratings will be measured at 30-minute intervals (0 hours [08:30], 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours and 4.5 hours). Participants will complete the Burghart ODOFIN Sniffin' Sticks smell test and the Burghart ODOFIN taste strips test at three time points during the trials (0 hours [08:30], 1.5 hours and 4 hours). Participants will rest for the duration of the trials except for performing 1 hour of treadmill exercise (walking/jogging) at 60% of their peak oxygen uptake (calculated from the pre-visit) between 0.5 to 1.5 hours (09:00-10:00) in the exercise trial. Expired air samples will be collected during exercise and for 30 minutes during the rest trial to calculate net energy expenditure and substrate oxidation. At 2.5 hours (11:00), an ad libitum lunch consisting of a homogeneous meal containing pasta, tomato sauce, and olive oil (72% carbohydrate, 12% protein, 16% fat, 6.5 kJ per gram of food) will be provided for 30 minutes (until 3 hours).
The MRI visit will take place after an overnight fast of at least 10 hours and will involve a 45 minute scanning protocol. Structural MRI and functional MRI (fMRI) scans will be performed on a GE 3.0 T Discovery MR750w scanner using a 32 channel head coil. Two fMRI scans will be performed (1) during the presentation of food and non-food cues and (2) for an equivalent duration whilst participants are not looking at food and non-food cues.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Loughborough, United Kingdom
- Loughborough University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Body mass index (BMI) between 18.5 - 24.9 kg/m2 and a waist circumference of ≤ 88 cm for women, and ≤ 102 cm for men or a BMI between 25 - 40 kg/m2 and a waist circumference of > 88 cm for women, and > 102 cm for men. BMI and waist circumference thresholds vary amongst ethnicities. People with a South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean family background are prone to central adiposity and their cardiometabolic risk occurs at a lower BMI. Therefore, the following BMI and waist circumference thresholds will be applied for people of South Asian, other Asian, Black African and African-Caribbean ethnicity: (1) BMI 18.5 kg/m2 to 23 kg/m2 and waist circumference of < 90 cm for men and < 80 cm for women; (2) BMI 23.1 kg/m2 to 40 kg/m2 and waist circumference of ≥ 90 cm for men and ≥ 80 cm for women.
- Normally consumes three meals a day
- Able to walk continuously for 1 hour on a treadmill
- Weight stable for 3 months (< 3kg change in weight)
- Regular menstrual cycle for the last 6 months (people taking the combined contraceptive pill are eligible for the study)
- Able to undergo a 45-minute MRI scan
Exclusion Criteria:
- Smokers (vaping is considered smoking in this study)
- Known medical conditions (e.g. diabetes, heart condition)
- Taking any medication which may affect the study outcomes (e.g. liraglutide, semaglutide, insulin, steroids, anti-psychotics)
- Clinically diagnosed eating disorder
- Previous bariatric surgery (e.g. gastric bypass, gastric band, sleeve gastrectomy)
- Food allergies or intolerances, or severe dislikes to study foods
- Pregnant or breastfeeding
- Have recently donated blood (within eight weeks of visits 2 and 3).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control
Rest in the laboratory from 08:00 to 13:00.
For 30-minutes, participants will be asked to wear a face mask, which will measure their oxygen consumption at rest.
Ad libitum energy intake assessed at 11:00 (2.5 hours).
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Experimental: Exercise
Rest in the laboratory from 08:00 to 13:00 apart from 60 minutes of treadmill exercise (walking/jogging) performed between 09:00-10:00 (0.5-1.5 hours).
Ad libitum energy intake assessed at 11:00 (2.5 hours).
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Exercise, which will involve 60 minutes of brisk walking, or jogging, at 60% of peak oxygen uptake.
Participants will be asked to wear a face mask, which will measure their oxygen consumption during the exercise session.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Concentration of Oxyntomodulin
Time Frame: Blood samples to measure oxyntomodulin are collected at 30-minute intervals (0 hours [08:30], 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours and 4 hours) in each trial.
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Plasma blood samples
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Blood samples to measure oxyntomodulin are collected at 30-minute intervals (0 hours [08:30], 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours and 4 hours) in each trial.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Concentration of Acylated Ghrelin
Time Frame: Blood samples to measure acylated ghrelin are collected at 30-minute intervals (0 hours [08:30], 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours and 4 hours) in each trial.
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Acylated Ghrelin.
Blood plasma sample.
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Blood samples to measure acylated ghrelin are collected at 30-minute intervals (0 hours [08:30], 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours and 4 hours) in each trial.
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Concentration of Leptin
Time Frame: Blood samples to measure leptin are collected at 0 hours [08:30] in each trial.
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Blood plasma sample.
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Blood samples to measure leptin are collected at 0 hours [08:30] in each trial.
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Concentration of Glucagon-like peptide 1
Time Frame: Blood samples to measure GLP-1 are collected at 30-minute intervals (0 hours [08:30], 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours and 4 hours) in each trial.
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Glucagon-like peptide 1 (GLP-1).
Blood plasma sample.
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Blood samples to measure GLP-1 are collected at 30-minute intervals (0 hours [08:30], 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours and 4 hours) in each trial.
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Concentration of Peptide YY
Time Frame: Blood samples to measure PYY are collected at 30-minute intervals (0 hours [08:30], 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours and 4 hours) in each trial.
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Peptide YY (PYY) plasma blood sample
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Blood samples to measure PYY are collected at 30-minute intervals (0 hours [08:30], 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours and 4 hours) in each trial.
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Concentration of Glucose
Time Frame: Blood samples to measure glucose are collected at 30-minute intervals (0 hours [08:30], 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours and 4 hours) in each trial.
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Blood plasma sample
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Blood samples to measure glucose are collected at 30-minute intervals (0 hours [08:30], 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours and 4 hours) in each trial.
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Visual analogue score (VAS) for subjective appetite
Time Frame: VAS is measured at 30-minute intervals (0 hours [08:30], 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours and 4.5 hours) in each trial.
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Participants subjective appetite sensations are assessed using 100mm visual analogue scales to measure four appetite constructs: 'hunger', 'fullness', 'satiety' and 'prospective food consumption'.
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VAS is measured at 30-minute intervals (0 hours [08:30], 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours and 4.5 hours) in each trial.
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Energy intake
Time Frame: The ad libitum pasta meal is provided at 2.5 hours (11:00)
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(kcal).
A large bowl containing an amount of pasta in excess of expected consumption is presented to participants for 30 minutes.
They are instructed to self-serve and to stop eating when they reach volitional satiation.
The remaining food is weighed and subtracted from the known quantity initially presented to calculate ad libitum energy intake.
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The ad libitum pasta meal is provided at 2.5 hours (11:00)
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Gustatory perceptions
Time Frame: The taste tests will take place at three time points during the trials: 0 hours [08:30], 1.5 hours and 4 hours.
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The Burghart ODOFIN taste strips test is used to evaluate participant's ability to detect different taste sensations.
It assesses the sensitivity of a person's taste buds to various taste qualities, including sweet, salty, sour, bitter, and umami (savoury) and some taste strips may have no taste at all (neutral).
The paper strips are placed in the middle of the anterior tongue and the participant will be asked to identify the taste.
Participants are asked to take a sip of water between each paper strip.
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The taste tests will take place at three time points during the trials: 0 hours [08:30], 1.5 hours and 4 hours.
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Olfactory perceptions
Time Frame: The smell tests will take place at three time points during the trials: 0 hours [08:30], 1.5 hours and 4 hours.
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The Burghart ODOFIN Sniffin' Sticks smell test is used to evaluate the person's ability to detect, identify, and differentiate various odours.
The test involves presenting a series of different odours in the form of sniff pens.
The participant will be asked to sniff each pen and then identify each odour from a card which is presented to them.
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The smell tests will take place at three time points during the trials: 0 hours [08:30], 1.5 hours and 4 hours.
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Task-based fMRI
Time Frame: 45-minute scan at baseline
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Brain responses to visual food cues assessed during the presentation of food and non-food images
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45-minute scan at baseline
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Resting state fMRI
Time Frame: 45-minute scan at baseline
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Functional activity of the brain assessed at rest.
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45-minute scan at baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David J Stensel, Loughborough University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18581
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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