Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000718145
Ethics application status
Approved
Date submitted
9/05/2019
Date registered
13/05/2019
Date last updated
11/11/2020
Date data sharing statement initially provided
13/05/2019
Date results provided
11/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of intragastric administration of L-leucine, L-isoleucine and L-valine on gastric emptying, gut hormone release and blood glucose in healthy, lean volunteers.
Scientific title
Effects of intragastric administration of L-leucine, L-isoleucine and L-valine on gastric emptying, gut hormone release and blood glucose in healthy, lean volunteers.
Secondary ID [1] 297778 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 312127 0
Diabetes 312128 0
Condition category
Condition code
Diet and Nutrition 310679 310679 0 0
Obesity
Metabolic and Endocrine 310680 310680 0 0
Diabetes
Oral and Gastrointestinal 310737 310737 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Assessment of blood glucose and gastric emptying, following administration of control, 10g L-Leucine, 10g L-Isoleucine or 10g L-Valine 30 min prior to a standardised mixed nutrient drink.

Subjects will receive, in randomized, double-blind fashion, a 100 ml intragastric bolus infusion of: i) 10g L-Leucine; ii) 10g L-Isoleucine; iii) 10g L-Valine; iv) saline (control). Subjects will receive one infusion per visit. All bolus infusions will be administered by the primary researcher. Study visits will be separated by 3-7 days. In addition, during study visits, the primary researcher will be present in order to closely monitor adherence to study protocol.

For each study visit a baseline blood sample, VAS, and breath sample will be collected (t = -31). At t = -31 the infusion will be administered over 1 minute using a feeding tube. At t = -20, -10, and -1 min further blood samples will be collected and VAS completed. At t = -1 min, subjects will consume, within 1 minute, a mixed-nutrient drink (Resource Plus, 500 kcal, 325 ml) labeled with 100 mg of 13C-acetate for measurement of gastric emptying by breath sampling, and 3g 3-OMG for measurement of glucose absorption. Blood samples and VAS will be taken every 15 minutes, and breath samples will be taken every 5 min, over the next hour (t = 0 to 60 min). Over the following hour, VAS and blood samples will be collected every half hour (t = 90, 120), and breath samples collected every 15 min (t = 75, 90, 105, 120).
Intervention code [1] 314016 0
Treatment: Other
Comparator / control treatment
Treatment: Other
Saline control (administered intragastrically) for within group comparison.
Control group
Placebo

Outcomes
Primary outcome [1] 319524 0
Plasma glucose response to the mixed nutrient Resource Plus drink.
Timepoint [1] 319524 0
Plasma glucose will be assessed from blood samples taken at t = -31, -20, -10, -1, 15, 30, 45, 60, 90, 120 min, where t = -31 is just prior to the time of the bolus administration and t = -1 is just prior to nutrient drink consumption.
Secondary outcome [1] 368577 0
Gastric emptying (measurement of 13CO2 in breath samples).
Timepoint [1] 368577 0
Breath samples will be collected at t = -31 min, every 5 minutes from t = 0 to 60 min, and every 15 minutes from t = 60 to 120 min.
Secondary outcome [2] 368578 0
Plasma concentrations of gastrointestinal hormones (e.g. GLP-1, GIP ), insulin and 3-OMG (composite secondary outcome)
Timepoint [2] 368578 0
Gut hormone release will be assessed from blood samples taken at t = -31, -20, -10, -1, 15, 30, 45, 60, 90, and 120 min.
Secondary outcome [3] 368579 0
Appetite perceptions using a VAS questionnaire: hunger.
Timepoint [3] 368579 0
VAS questionnaires will be completed at t = -31, -20, -10, -1, 15, 30, 45, 60, 90, and 120 min.
Secondary outcome [4] 368580 0
Appetite perceptions using a VAS questionnaire: fullness.
Timepoint [4] 368580 0
VAS questionnaires will be completed at t = -31, -20, -10, -1, 15, 30, 45, 60, 90, and 120 min.
Secondary outcome [5] 368581 0
Appetite perceptions using a VAS questionnaire: desire to eat.
Timepoint [5] 368581 0
VAS questionnaires will be completed at t = -31, -20, -10, -1, 15, 30, 45, 60, 90, and 120 min.
Secondary outcome [6] 368582 0
Appetite perceptions using a VAS questionnaire: amount of food desired to eat.
Timepoint [6] 368582 0
VAS questionnaires will be completed at t = -31, -20, -10, -1, 15, 30, 45, 60, 90, and 120 min.

Eligibility
Key inclusion criteria
A total of 16 healthy, lean (BMI 19-25 kg/m2) male subjects, aged between 18 - 55 years will be included. Subjects will be required to be weight stable (ie <5% fluctuation) at study entry, which will be ascertained by a stable body weight in the preceding 4 weeks.
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Significant gastrointestinal symptoms, disease or surgery;
Use of prescribed or non-prescribed medications (including vitamins and herbal supplements) which may affect energy metabolism, gastrointestinal function, body weight or appetite (eg domperidone and cisapride, anticholinergic drugs (eg atropine), metoclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St Johns Wort etc.)
Lactose intolerance/other food allergy(ies)
Current gallbladder or pancreatic disease
Cardiovascular or respiratory diseases
Those with low ferritin levels (less than 30 ng/mL), or who have donated blood in the 12 weeks prior to taking part in the study
Any other illnesses as assessed by the investigator (including chronic illnesses not explicitly listed above)
High performance athletes
Current intake of greater than 2 standard drinks on greater than 5 days per week
Current smokers of cigarettes/cigars/marijuana
Current intake of any illicit substance
Vegetarians
Inability to comprehend study protocol
Restrained eaters (score >12 on the three factor eating questionnaire)

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)
Eligible volunteers are assigned a subject number and randomised treatment for each study visit. Randomisation involves contacting the holder (study assistant) of the randomisation table to inform them of the next subjects details and study dates. The unblinded study assistant is therefore responsible for allocating a random treatment to the subject and preparing the solution on each study day.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation is generated using a randomization plan generator available at www.randomization.com
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
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/05/2019
Actual
30/05/2019
Date of last participant enrolment
Anticipated
16/12/2019
Actual
16/12/2019
Date of last data collection
Anticipated
30/12/2019
Actual
25/12/2019
Sample size
Target
15
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 302303 0
Government body
Name [1] 302303 0
NHMRC
Country [1] 302303 0
Australia
Primary sponsor type
Individual
Name
Christine Feinle-Bisset
Address
Discipline of Medicine
University of Adelaide
Level 5 Adelaide Health and Medical Sciences Building,
Cnr George St and North Tce
Adelaide, SA 5005
Country
Australia
Secondary sponsor category [1] 302179 0
Individual
Name [1] 302179 0
Michael Horowitz
Address [1] 302179 0
Discipline of Medicine
University of Adelaide
Level 5 Adelaide Health and Medical Sciences Building,
Cnr George St and North Tce
Adelaide, SA 5005
Country [1] 302179 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302977 0
Central Adelaide Local Health Network Research Ethics Committee
Ethics committee address [1] 302977 0
Ethics committee country [1] 302977 0
Australia
Date submitted for ethics approval [1] 302977 0
04/02/2019
Approval date [1] 302977 0
05/02/2019
Ethics approval number [1] 302977 0
HREC/14/RAH/286

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

Contacts
Principal investigator
Name 92046 0
Prof Chrisitine Feinle-Bisset
Address 92046 0
Discipline of Medicine
University of Adelaide
Level 5 Adelaide Health and Medical Sciences Building,
Cnr George St and North Tce
Adelaide, SA 5005
Country 92046 0
Australia
Phone 92046 0
+61 8 8313 6053
Fax 92046 0
Email 92046 0
[email protected]
Contact person for public queries
Name 92047 0
Penelope Fitzgerald
Address 92047 0
Discipline of Medicine
University of Adelaide
Level 5 Adelaide Health and Medical Sciences Building,
Cnr George St and North Tce
Adelaide, SA 5005
Country 92047 0
Australia
Phone 92047 0
+61 8 8313 6278
Fax 92047 0
Email 92047 0
[email protected]
Contact person for scientific queries
Name 92048 0
Chrisitine Feinle-Bisset
Address 92048 0
Discipline of Medicine
University of Adelaide
Level 5 Adelaide Health and Medical Sciences Building,
Cnr George St and North Tce
Adelaide, SA 5005
Country 92048 0
Australia
Phone 92048 0
+61 8 8313 6053
Fax 92048 0
Email 92048 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
To align with intellectual property agreement.


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
SourceTitleYear of PublicationDOI
EmbaseComparative effects of the branched-chain amino acids, leucine, isoleucine and valine, on gastric emptying, plasma glucose, c-peptide and glucagon in healthy men.2021https://dx.doi.org/10.3390/nu13051613
N.B. These documents automatically identified may not have been verified by the study sponsor.