Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000291785
Ethics application status
Approved
Date submitted
12/03/2013
Date registered
14/03/2013
Date last updated
6/11/2018
Date data sharing statement initially provided
6/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of exercise on hunger, antropyloroduodenal motility, and gut hormones
Scientific title
The effects of exercise on hunger, antropyloroduodenal motility, and gut hormones in healthy male volunteers
Secondary ID [1] 282074 0
N/A
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physiological study to investigate the effects of exercise on hunger, antropyloroduodenal motility, and gut hormones in healthy volunteers. 288564 0
Condition category
Condition code
Oral and Gastrointestinal 288896 288896 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sixteen (BMI 19-25 kg/m2) healthy subjects, aged between 18 - 35 years, will be recruited. All subjects will be required to be weight-stable at study entry, as determined by their self-reported weight in the preceding 3 months, and will be required to maintain their normal physical activity over the course of the study.
Each subject will be studied on three occasions, separated by at least 3 (and up to 7) days. Each visit will be either sedentary or involve exercise on a treadmill at one of two intensities (35 and 70% VO2max) for 60 minutes, with the three interventions administered in a counter-balanced order, by administering the various procedures in different sequences. On each occasion antropyloroduodenal motility, plasma CCK, ghrelin, GLP-1, and PYY concentrations, appetite perceptions, energy intake and energy expenditure will be measured.
Peak aerobic capacity of each subject will be determined within a week before the start of the study using a screening treadmill test (GXT), which will be supervised by a medical doctor in the Department of Medicine. This test involves collection of ventilatory and respirometric measurements from the subject during progressive increases in speed (0.8 km/h/2 min) while walking/running on a level treadmill. During the GXT, subjects will be monitored with a Polar a 12-lead electrocardiogram will be performed, and blood pressure will also be monitored. The subjects will also wear the SenseWear bands to provide a direct comparison with the VO2 max test.. During this screening test, as well as at intervals during the study, subjects will breathe through a mouthpiece equipped with a two-way valve. This protocol is well established and commonly used in exercise studies (62). Peak oxygen consumption (VO2peak) will be measured from expired gases that are continuously sampled from a mixing-chamber and analyzed for gas flow and for oxygen (O2) and carbon dioxide (CO2) concentrations by a metabolic cart (VO2000, Medgraphics, St. Paul, MN, USA). Heart rate will be monitored with a Polar® heart rate strap and watch.
Intervention code [1] 286672 0
Treatment: Other
Comparator / control treatment
Sedentary
Participants will be required to remain lying down during the sedentary study for 60 minutes. Measurements will be made at the same time points as for the exercise interventions. On this occasion antropyloroduodenal motility, plasma CCK, ghrelin, GLP-1, and PYY concentrations, appetite perceptions, energy intake and energy expenditure will be measured.
Control group
Active

Outcomes
Primary outcome [1] 289026 0
Antropyloroduodenal motility (number of antral, duodenal and isolated pyloric pressure waves, and basal pyloric pressure)
Timepoint [1] 289026 0
Using a manometric assembly and catheter, antropyloroduodenal pressures will be monitored from intubation until 120 minutes.
Primary outcome [2] 289027 0
Plasma concentrations of gastrointestinal hormones (e.g. CCK, GLP-1, PPY, and ghrelin, and other novel gut peptides that may become of interest over the course of the study)
Timepoint [2] 289027 0
Gut hormone release will be assessed by enzyme linked immunosorbent assay (ELISA) or radioimmuno assay (RIA) from blood samples taken at t= -15, 0, 15, 30, 45, 60, 75, 90, 105, 120 & 150 minutes.
Secondary outcome [1] 301596 0
Appetite ratings using a visual analogue scale (VAS) which include hunger, fullness, desire to eat, and amount of food desired to eat and macronutrient and total energy intake at the buffet meal.
Timepoint [1] 301596 0
VAS questionnaires are taken at t= -15, 0, 15, 30, 45, 60, 75, 90, 105, 120 & 150 minutes. The buffet meal will be presented at t=120 minutes and the subject will be allowed to freely consume food until comfortably full for 30 minutes (until t= 150 minutes).
Secondary outcome [2] 301597 0
Vital signs (heart rate, blood pressure, and energy expenditure)
Timepoint [2] 301597 0
Sensewear bands will be worn to assess energy expenditure and will occur for 15 minutes upon the subject’s arrival at the laboratory and during the 60-min exercise or sedentary period.

Eligibility
Key inclusion criteria
Sixteen (BMI 19-25 kg/m2) healthy subjects, aged between 18 - 35 years, will be recruited. All subjects will be required to be weight-stable (i.e. < 5 % fluctuation in their body weight) at study entry, as determined by their self-reported weight in the preceding 3 months, and will be required to maintain their normal physical activity over the course of the study.
Minimum age
19 Years
Maximum age
35 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Each subject will be questioned prior to the study to exclude:
- significant GI symptoms, disease or surgery
- use of prescribed or non-prescribed medications (including vitamins and herbal supplements) which may affect energy metabolism, GI function, body weight or appetite (e.g. domperidone and cisapride, anticholinergic drugs (eg atropine), metoclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St Johns Wort etc.)
- lactose intolerance or other food allergy(s)
- current gallbladder or pancreatic disease
- diabetes mellitus
- epilepsy
- cardiovascular or respiratory diseases
- any other illnesses as assessed by the investigator (including chronic illnesses not explicitly listed above)
- high performance athletes
- current intake of > 2 standard drinks on > 5 days per week
- current smokers of cigarettes/cigars/marijuana
- current intake of any illicit substance
- restrained eaters (score > 12 on the three factor eating questionnaire)
- experience of claustrophobia in confined spaces
- inability to tolerate nasoduodenal tube
- inability to comprehend study protocol

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Volunteers are asked to visit the clinic for a 30 minute screening visit. A questionnaire is is answered by the volunteer, based on the inclusion/exclusion criteria and eligibility is determined. A signed consent form is obtained.
Peak aerobic capacity of each subject will be determined within a week before the start of the study using a screening treadmill test (GXT). This test involves collection of ventilatory and respirometric measurements from the subject during progressive increases in speed (0.8 km/h/2 min) while walking/running on a level treadmill. During the GXT, subjects will be monitored with a Polar a 12-lead electrocardiogram will be performed, and blood pressure will also be monitored.
Eligible volunteers are assigned a subject number and randomised into a treatment for each study visit, using a randomisation table created on an excel spreadsheet. Randomisation involved contacting the holder (study assistant) of the randomisation table to inform them of the next subjects details and study dates. The unblinded assistant is therefore responsible for allocating random treatment to the subject.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation table was generated using Microsoft Office Excel
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/07/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 286879 0
University
Name [1] 286879 0
Discipline of Medicine, University of Adelaide
Country [1] 286879 0
Australia
Primary sponsor type
Individual
Name
Christine Feinle-Bisset
Address
Level 6 Eleanor Harrald Building
Frome Road
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 285670 0
Individual
Name [1] 285670 0
Elizabeth Wuorinen
Address [1] 285670 0
Level 6 Eleanor Harrald Building
Frome Road
Adelaide SA 5000
Country [1] 285670 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288942 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 288942 0
Ethics committee country [1] 288942 0
Australia
Date submitted for ethics approval [1] 288942 0
31/01/2013
Approval date [1] 288942 0
25/03/2013
Ethics approval number [1] 288942 0
130218

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38314 0
Prof Christine Feinle-Bisset
Address 38314 0
Discipline of Medicine
university of Adelaide
Level 6 Eleanor Harrald Building
Frome Road
Adelaide SA 5005
Country 38314 0
Australia
Phone 38314 0
+61 8 8222 5247
Fax 38314 0
Email 38314 0
[email protected]
Contact person for public queries
Name 38315 0
Christine Feinle-Bisset
Address 38315 0
Discipline of Medicine
university of Adelaide
Level 6 Eleanor Harrald Building
Frome Road
Adelaide SA 5005
Country 38315 0
Australia
Phone 38315 0
+61 8 8222 5247
Fax 38315 0
Email 38315 0
[email protected]
Contact person for scientific queries
Name 38316 0
Christine Feinle-Bisset
Address 38316 0
Discipline of Medicine
university of Adelaide
Level 6 Eleanor Harrald Building
Frome Road
Adelaide SA 5005
Country 38316 0
Australia
Phone 38316 0
+61 8 8222 5247
Fax 38316 0
Email 38316 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.