ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12609000888268

Ethics application status

Approved

Date submitted

8/10/2009

Date registered

12/10/2009

Date last updated

31/05/2012

Type of registration

Prospectively registered

Titles & IDs

Public title

Can a high fibre diet reduce the amount of insulin the body needs to process the sugar consumed in meals?

Scientific title

Can supplemented dietary fibre improve insulin sensitivity in obese adolescents?
A randomized cross-over trial of a high fibre isocaloric diet compared to an isocaloric diet alone in a secondary school community with a high incidence of obesity.

Secondary ID [1]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Insulin resistance in a population with a high rate of obesity

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants will be randomized to recieve 6g per day psyllium or 6g/d potato starch placebo for 6 weeks on each intervention. Psyllium and placebo will be given as 6g/day as 12 x 500mg capsules, with participants instructed to consume these at once or in divided doses with a large glass of water. After 6 weeks participants will washout for 2 weeks before starting 6 weeks on the opposite intervention.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

While on placebo or psyllium, both groups with be able to eat a normal diet.A diet recall questionaire will be given to both groups after randomization, to ensure that the groups are similar in terms of calorie intake, and the percent energy derived from fat, carbohydrate, protein, and that they have a similar background fibre intake The intervention is supplemented fibre or placebo as described above

Control group

Placebo

Outcomes

Primary outcome [1]

Insulin sensitivity. This will meaured through the matsuda method which is the best model to the gold standard euglycaemic clamp. This involved overnight fasting, with a oral glucose tolerance test, with measurements at 0min, 30 min, 60, 90 and 120 of serum insulin and glucose. That matsuda index calculation gives an insulin sensitivity score.
Equipment will be IV cannulation, and syringes to draw the venous samples at the time points as described above. The Liggins Institute has an in house assay for insulin levels.

Timepoint [1]

Baseline, 6 week cross over, and completion (14 weeks)

Secondary outcome [1]

Body Mass Index

Timepoint [1]

Baseline, 6 week cross over, and completion (14 weeks)

Secondary outcome [2]

Blood pressure. This will be through 24hour ambulatory blood pressure monitoring.

Timepoint [2]

Baseline, 6 week cross over, and completion (14 weeks)

Eligibility

Key inclusion criteria

15 - 16 year old males from low socio-economic areas.

Minimum age

15 Years

Maximum age

16 Years

Sex

Males

Can healthy volunteers participate?

Yes

Key exclusion criteria

Receiving medications that influence insulin sensitivity (SI) (incluing oral steroids and metformin).
Genetic conditions, (Turner, Downs or Prader-Willi syndrome).
Coeliac disease or other malabsorption disorders.

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)

Central randomization by computer

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

Simple randomization by using a table created by computer software.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/02/2010

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Auckland / Liggins Institute

Address [1]

The Liggins Institute, The University of Auckland, Private Bag 92019, Auckland 1142, New Zealand

Country [1]

New Zealand

Primary sponsor type

University

Name

University of Auckland / Liggins Institute

Address

The Liggins Institute, The University of Auckland, Private Bag 92019, Auckland 1142, New Zealand

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Regional Y Ethic Committee

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

30/10/2009

Approval date [1]

Ethics approval number [1]

NTY09/12/124

Summary

Brief summary

The purpose of the study is to formally assess the impact of fibre alone on insulin sensitivity, and if this is achieved independently of weight loss. Fibre will be givenas a supplement, without altering other aspects of the diet. The hypothesis is that the properties of fibre can benefit insulin senstivity independently of weight loss, clarifying its role in dietary interventions for overweight, and normal weight insulin resistant people. We expect the effect to be greatest in the obese population.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

martin de Bock

Address

3A/10 Laxon Tce
Newmarket
Auckland
1050

Country

New Zealand

Phone

+64 211826579

Fax

[email protected]

Contact person for scientific queries

Name

martin de Bock

Address

3A/10 Laxon Tce
Newmarket
Auckland
1050

Country

New Zealand

Phone

+64211826579

Fax

[email protected]

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
Dimensions AI	Psyllium Supplementation in Adolescents Improves Fat Distribution & Lipid Profile: A Randomized, Participant-Blinded, Placebo-Controlled, Crossover Trial	2012	https://doi.org/10.1371/journal.pone.0041735

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

Trial Review

Documents added manually

Documents added automatically