Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000080527
Ethics application status
Approved
Date submitted
24/07/2023
Date registered
30/01/2024
Date last updated
30/01/2024
Date data sharing statement initially provided
30/01/2024
Date results provided
30/01/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acute Food Intake and Dual X-ray Absorptiometry Body Composition Evaluation
Scientific title
Effect of Acute Liquid Food and Water Intake on Dual X-ray Absorptiometry (DXA) Body Composition Measurement in Healthy Males
Secondary ID [1] 310184 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sedentary healthy young men 332010 0
Condition category
Condition code
Diet and Nutrition 327639 327639 0 0
Obesity
Musculoskeletal 328748 328748 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will be provided liquid food and water before being measured by a DXA body composition device.


- 500 ml liquid food and 1500 ml water to be consumed within the 1 hour and they were told not to urinate during this period

-The frequency/duration of the intervention: Once/3 hours

-The mode of administration: One-on-one face-to-face

-Participants will be provided with a standard liquid food (Ensure Plus, Abbott Nutrition, UK) containing a total of 750 kcal (protein 15%, carbohydrate 57%, fat 28%), sodium (120 mg/100 mL), and potassium (200 mg/100 mL). The liquid food's osmolality and renal solute load were 680 mOsm/kg H2O and 430 mOsm/L, respectively. They will also be provided with 1500ml tap water.

-Research staff and participants will stay in the same room during the 1-hour liquid food and 1500ml water consumption stage and liquid food and water bottles will be checked upon completion to confirm their full emptiness.



-Participants’ position on the DXA table was adjusted strictly according to the National Health and Nutrition Examination Survey (NHANES) and manufacturer guidelines (Lunar GH, 2017): head straight, body in a supine position, and centered the table, a small amount of space remained between the arms and torso, hands on sides, and feet together. In detail, the subject’s hands are turned on sides with thumbs up, palms facing legs, and arms are alongside the subject’s body. Hands were contactless to legs and given a small air gap (~1 cm) between the arms and torso. It will be confirmed that the subject’s arms, legs, and trunk are within the scan area lines on the table pad. It was also secured that the subject’s head is approximately 3 cm below the horizontal line on the table pad. Following this, the Velcro straps are used to tighten the subject’s knees and feet to prevent movement during the entire period of the scan. All the potential attenuating materials (belts, metal buttons, etc.) are removed from the subject’s body and the measurement region.

Lunar GH (2017) enCORE-based x-ray Bone Densitometer: User Manual. Madison (WI): GE Healthcare; 2013.


The technical staff (Biologist and Exercise Physiologist) is responsible for using the DXA machine for whole-body scans.

-The duration of the DXA measures: On average 5-10 min (depending on body sizes of participants) 1 hour after consumption of water and liquid food.
Intervention code [1] 326584 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335449 0
True body composition measurements, total mass, lean tissue mass (LTM), fat mass (FM), and bone mineral content (BMC) by DXA will be assessed as a composite primary outcome.
Timepoint [1] 335449 0
Baseline (in a fasting state), 1 hour after liquid food and water intake (primary timepoint), and immediately after bladder voiding.
Secondary outcome [1] 424592 0
The acute liquid food intake and acute water intake will be assessed as a composite secondary outcome.
Timepoint [1] 424592 0
1 hour after liquid food and water intake.

Eligibility
Key inclusion criteria
Healthy male subjects
Minimum age
18 Years
Maximum age
30 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
29/07/2019
Date of last participant enrolment
Anticipated
Actual
31/05/2023
Date of last data collection
Anticipated
Actual
21/07/2023
Sample size
Target
65
Accrual to date
Final
63
Recruitment outside Australia
Country [1] 25660 0
Turkey
State/province [1] 25660 0
Ankara

Funding & Sponsors
Funding source category [1] 314352 0
Self funded/Unfunded
Name [1] 314352 0
Nill
Country [1] 314352 0
Primary sponsor type
Individual
Name
Suleyman Bulut, PhD
Address
Hacettepe University, Faculty of Sport Sciences, Division of Exercise and Nutrition Metabolism, Beytepe Campus, Cankaya, 06800, Ankara
Country
Turkey
Secondary sponsor category [1] 316298 0
None
Name [1] 316298 0
Nill
Address [1] 316298 0
Nill
Country [1] 316298 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313447 0
Hacettepe University Institutional Review Board
Ethics committee address [1] 313447 0
Ethics committee country [1] 313447 0
Turkey
Date submitted for ethics approval [1] 313447 0
02/01/2015
Approval date [1] 313447 0
21/01/2015
Ethics approval number [1] 313447 0
GO 15/28

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

Contacts
Principal investigator
Name 128194 0
A/Prof Suleyman BULUT
Address 128194 0
Hacettepe University, Faculty of Sport Sciences, Exercise and Nutrition Metabolism Division, Beytepe Campus, 06800, Ankara
Country 128194 0
Turkey
Phone 128194 0
+903122976890
Fax 128194 0
+903122992167
Email 128194 0
[email protected]
Contact person for public queries
Name 128195 0
Suleyman BULUT
Address 128195 0
Hacettepe University, Faculty of Sport Sciences, Exercise and Nutrition Metabolism Division, Beytepe Campus, Ankara
Country 128195 0
Turkey
Phone 128195 0
+903122976890
Fax 128195 0
+903122992167
Email 128195 0
[email protected]
Contact person for scientific queries
Name 128196 0
Suleyman BULUT
Address 128196 0
Hacettepe University, Faculty of Sport Sciences, Exercise and Nutrition Metabolism Division, Beytepe Campus, 06800, Ankara
Country 128196 0
Turkey
Phone 128196 0
+903122976890
Fax 128196 0
+903122992167
Email 128196 0
[email protected]

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19794Ethical approvalHacettepe University Institutional Review Boardhttps://etikkurul.hacettepe.edu.tr/yerel/yonerge.php[email protected] 386284-(Uploaded-24-07-2023-19-58-27)-Study-related document.pdf
19797Informed consent form  [email protected] 386284-(Uploaded-24-07-2023-19-59-40)-Study-related document.docx



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.