ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12612000429853

Ethics application status

Approved

Date submitted

12/04/2012

Date registered

17/04/2012

Date last updated

22/09/2015

Type of registration

Retrospectively registered

Titles & IDs

Public title

Targeting the ileal brake – effects of carbohydrate (CHO) on hunger, satiety and energy intake

Scientific title

Targeting the ileal brake – effects of carbohydrate (CHO) on hunger, satiety and energy intake: A Tube Feeding Study in healthy male participants

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Appetite regulation

Condition category

Condition code

Oral and Gastrointestinal

Normal oral and gastrointestinal development and function

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This is a gastrointestinal infusion study where a CHO load or saline control will be infused directly into the distal ileum and the proximal duodenum using an extended naso-gastric (NG) feeding tube (catheter). Introduction of an NG catheter is a commonly used clinical procedure in enterally fed patients.
The objective of this study is to determine whether direct infusion of dietary CHO into the distal small intestine (terminal ileum) alters appetite-related sensations and food intake in a group of lean healthy men.
The study aims to determine the effect of CHO infused into the ileum using a naso-ileal (NI) tube on:
(i) subjective VAS-rated feelings of hunger, fullness and associated measures of satiety
(ii) energy intake at a subsequent lunch and dinner meal
(iii) gut peptides associated with satiety including cholecystokinin (CCK), glucagon-like peptide-1 (GLP-1) and peptide YY (PYY)
The primary hypotheses are:

1. Infusion of a CHO load into the ileum will increase satiety and decrease subsequent food intake when compared with a duodenal infusion

2. Infusion of a CHO load into the ileum will increase circulating levels of the appetite-related gut peptides CCK, GLP-1 and PYY.

This is a 5 day residential study.
Infusions:
Four treatments comprising:
1. Saline control – infused into the duodenum
2. Glucose - infused into the duodenum
3. Saline control - infused into the ileum
4. Glucose - infused into the ileum

The CHO dose will be a 15g bolus of glucose

The infusions wil be administered over a duration of 1.5 hours. Participants will receive all 4 infusion treatments in a random order

Intervention code [1]

Treatment: Other

Comparator / control treatment

Saline

Control group

Placebo

Outcomes

Primary outcome [1]

Visual Analogue Scale (VAS) scores for hunger and fullness.

Timepoint [1]

Subjective ratings of satiety and nausea measured using visual analogue scales (VAS) at -120, -105, -90, -60, -30 & 0 (immediately before the test preload), 15, 30, 45, 60, 90, 120 (ad lib lunch), 150, 180, 240, 300, 360, 420 and 480 (ad lib dinner) and 510 minutes post preload.
t = 0 is the time that the infusion (treatment) begins

Secondary outcome [1]

Timepoint [1]

Immediately post the ad libitum lunch, snack & dinner meals (t=150, t=255 and t=510)

Eligibility

Key inclusion criteria

Male
Age 18-60 years
Lean, as defined by BMI <25kg/m2
Healthy, as ascertained by self-report and blood test

Minimum age

18 Years

Maximum age

60 Years

Sex

Males

Can healthy volunteers participate?

Yes

Key exclusion criteria

Overweight
Any medical conditions or medications known to affect appetite -related parameters, including depression
Low iron status, hence unsuitable for cannulation studies
Participation in an active diet program and/or loss/gain of >10% body weight within the last 6 months
Smoker or ex-smoker who quit within the last 6 months
Hypersensitivities or allergies to any foods or ingredients included in the study
Dislike and/or unwilling to consume items listed as study foods
Unwilling/unable to comply with study protocol
Participating in another clinical intervention trial

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)

This is a randomised, cross-over trial. Randomisation is carried out using a Latin square design, whereby the order at which participants agree to commence the study determines the order at which they receive the treatments Participants are randomized to receive all 4 treatments. the person who determined if a subject was eligible for inclusion in the trial was unaware, when this decision was made, to which group the subject would be allocated.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

A Latin square will be used to randomise the subjects to each of the 4 intervention arms. Each participant is randomized to complete all 4 intervention arms.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

19/10/2011

Actual

19/10/2011

Date of last participant enrolment

Anticipated

Actual

21/05/2012

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Foundation for Science and Research (FRST)/Ministry of Science Innovation

Address [1]

Wellington office
Level 3, 33 Bowen Street.

PO Box 5762
Wellington 6145

Country [1]

New Zealand

Primary sponsor type

Government body

Name

Foundation for Science and Research (FRST)Ministry of Science Innovation

Address

Wellington office
Level 3, 33 Bowen Street.

PO Box 5762
Wellington 6145

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

University

Name [1]

The University of Auckland

Address [1]

Human Nutrition Unit
University of Auckland
18 Carrick Place
Mt Eden
Auckland 1024

Country [1]

New Zealand

Other collaborator category [2]

Commercial sector/Industry

Name [2]

Plant & Food Research Ltd

Address [2]

120 Mt Albert Road
Sandringham 1142
Auckland

Country [2]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Y Regional Ethics Committee

Ethics committee address [1]

C/o Ministry of Health
PO Box 1031
Hamilton 3240

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

16/08/2011

Ethics approval number [1]

NTY/11/03/034

Summary

Brief summary

The GI tract is the source of a large number of signals and mechanisms purported to be involved in the control of satiety, and which are generated by various types of mechanical or chemical stimuli.  Mechanical stimulation is provided by distension of the luminal wall as foods transit the length of the gut, whilst chemical stimulation is provided by the nutrients entering the small and possibly also the large intestine. These stimuli then result in release of GI peptides and/or the activation of neural signals which may alter appetite-related sensations and eating behaviour.

Secretion of GI peptides, when combined with neural signals from the stomach and small intestine generated by GI distension during and after meal ingestion, may lead to meal termination (=satiation) or may influence hunger and fullness between meals (=satiety). 

The ileum, or distal small intestine, has become the focus of recent studies which have hypothesised that stimulation of the ileum as a consequence of nutrient arrival may generate a range of satiety signals which enhance fullness, suppress hunger and decrease food intake. The mechanism by which this may occur has been termed the ‘Ileal Brake’. 

There are a range of feeding studies (Burns et al., 2000; Burns et al., 2001; Burns et al., 2002; Diepvens et al., 2007; Chan et al., 2010; Smit et al., 2010) which have shown appetite suppression in which the authours have attributed the effect to the delivery of nutrients to the ileum which in turn has stimulated the ileal brake. Studies conducted to date have focused on the delivery of dietary lipids, in particular lipid emulsions (Read et al., 1984a; Van Citters & Lin, 1999). Long-chain fatty acids are potent triggers of the ileal brake & several studies have demonstrated that the ileal brake may be activated by small amounts of fat or free fatty acids. The ileal brake has also been identified as a potentially important mechanism following delivery of CHO's.

Trial website

Trial related presentations / publications

The results of this trial have not been published, yet.

Public notes

Contacts

Principal investigator

Name

Prof Sally Poppitt

Address

Human Nutrition Unit
18 Carrick Place, Mt Eden, Auckland, 1024
New Zealand

Country

New Zealand

Phone

+6496306160

Fax

s.poppitt@auckland.ac.nz

Contact person for public queries

Name

Sally Poppitt

Address

Human Nutrition Unit
University of Auckland
18 Carrick Place
My Eden
Auckland 1024

Country

New Zealand

Phone

+64 9 630 5160

Fax

+64 9 630 5764

s.poppitt@auckland.ac.nz

Contact person for scientific queries

Name

Sally Poppitt

Address

Human Nutrition Unit
University of Auckland
18 Carrick Place
My Eden
Auckland 1024

Country

New Zealand

Phone

+64 9 630 5160

Fax

+64 9 630 5764

s.poppitt@auckland.ac.nz

No information has been provided regarding IPD availability

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

Source	Title	Year of Publication	DOI
Embase	Duodenal and ileal glucose infusions differentially alter gastrointestinal peptides, appetite response, and food intake: A tube feeding study.	2017	https://dx.doi.org/10.3945/ajcn.117.157248

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

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Documents added manually

Documents added automatically