ANZCTR - Registration

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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 information initially 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]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Obesity

Diabetes

Condition category

Condition code

Diet and Nutrition

Obesity

Metabolic and Endocrine

Diabetes

Oral and Gastrointestinal

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]

Treatment: Other

Comparator / control treatment

Treatment: Other
Saline control (administered intragastrically) for within group comparison.

Control group

Placebo

Outcomes

Primary outcome [1]

Plasma glucose response to the mixed nutrient Resource Plus drink.

Timepoint [1]

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]

Gastric emptying (measurement of 13CO2 in breath samples).

Timepoint [1]

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]

Plasma concentrations of gastrointestinal hormones (e.g. GLP-1, GIP ), insulin and 3-OMG (composite secondary outcome)

Timepoint [2]

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]

Appetite perceptions using a VAS questionnaire: hunger.

Timepoint [3]

VAS questionnaires will be completed at t = -31, -20, -10, -1, 15, 30, 45, 60, 90, and 120 min.

Secondary outcome [4]

Appetite perceptions using a VAS questionnaire: fullness.

Timepoint [4]

VAS questionnaires will be completed at t = -31, -20, -10, -1, 15, 30, 45, 60, 90, and 120 min.

Secondary outcome [5]

Appetite perceptions using a VAS questionnaire: desire to eat.

Timepoint [5]

VAS questionnaires will be completed at t = -31, -20, -10, -1, 15, 30, 45, 60, 90, and 120 min.

Secondary outcome [6]

Appetite perceptions using a VAS questionnaire: amount of food desired to eat.

Timepoint [6]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra
ACT 2601

Country [1]

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]

Individual

Name [1]

Michael Horowitz

Address [1]

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]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Adelaide Local Health Network Research Ethics Committee

Ethics committee address [1]

Level 3, Roma Mitchell House
136 North Tce
Adelaide SA 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/02/2019

Approval date [1]

05/02/2019

Ethics approval number [1]

HREC/14/RAH/286

Summary

Brief summary

This study will investigate the effects of intragastric administration of specific L-amino acids on gastric emptying, gut hormone release, glycaemic control and appetite perceptions in healthy, lean males. We hypothesize that the gastric emptying, gastrointestinal hormone, glycemic and appetite repsonses will be affected by specific L-amino acids in healthy lean males.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Chrisitine 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

Phone

+61 8 8313 6053

Fax

[email protected]

Contact person for public queries

Name

Ms Penelope Fitzgerald

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

Phone

+61 8 8313 6278

Fax

[email protected]

Contact person for scientific queries

Name

Prof Chrisitine 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

Phone

+61 8 8313 6053

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		Our study shows that both leucine and isoleucine ... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Comparative effects of the branched-chain amino acids, leucine, isoleucine and valine, on gastric emptying, plasma glucose, c-peptide and glucagon in healthy men.	2021	https://dx.doi.org/10.3390/nu13051613

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically