ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12614001131640

Ethics application status

Approved

Date submitted

9/10/2014

Date registered

23/10/2014

Date last updated

20/12/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

The effect of protein “preloads” on postprandial glycaemia in type 2 diabetes: a 12-week, single-blind, randomised and placebo-controlled trial.

Scientific title

The effect of a 12-week, single-blind, randomised and placebo-controlled trial of whey protein “preloads” on glycated haemoglobin in patients with type 2 diabetes.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Type 2 diabetes mellitus

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Metabolic and Endocrine

Diabetes

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Protein shake containing 20g whey and 5g guar gum, along with flavouring and artificial sweetener, in 150 mL water, taken 15 min twice daily (before their usual morning and evening meal) for 12 weeks. Adherence will be monitored by package counts every two weeks during the intervention and telephone calls on the alternate weeks.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Placebo shake containing flavouring and artificial sweetener in 150 mL water, taken 15 min twice daily (before the morning and evening meal) for 12 weeks

Control group

Placebo

Outcomes

Primary outcome [1]

Glycated haemoglobin (HbA1c) - difference in the change in HbA1c after the intervention between active treatment and placebo

Timepoint [1]

12 weeks

Secondary outcome [1]

Rate of gastric emptying of a standardised meal, consisting of 65g instant mashed potato and 20g glucose, reconstituted with 200 mL water and 1 egg yolk containing 100 microL 13C-octanoic acid, and evaluated using a 13C breath test

Timepoint [1]

0 and 12 weeks

Secondary outcome [2]

Insulin concentrations, evaluated using plasma assay

Timepoint [2]

At 0, 15, 30, 60, 90, 120, 180 and 240 min after the standardised meal at 0 and 12 weeks

Secondary outcome [3]

Blood glucose concentrations

Timepoint [3]

At 0, 15, 30, 60, 90, 120, 180 and 240 min after the standardised meal at 0 and 12 weeks

Secondary outcome [4]

C-peptide concentrations, evaluated using plasma assay

Timepoint [4]

At 0, 15, 30, 60, 90, 120, 180 and 240 min after the standardised meal at 0 and 12 weeks

Secondary outcome [5]

Incretin hormone concentrations, evaluated using plasma assay

Timepoint [5]

At 0, 15, 30, 60, 90, 120, 180 and 240 min after the standardised meal at 0 and 12 weeks

Secondary outcome [6]

Appetite scores, evaluated using 100mm visual analogue scales

Timepoint [6]

At 0, 15, 30, 60, 90, 120, 180 and 240 min after the standardised meal at 0 and 12 weeks

Secondary outcome [7]

Body composition as measured by dual energy X-ray absorptiometry

Timepoint [7]

0 and 12 weeks

Secondary outcome [8]

Body weight, evaluated using digital weighing scales

Timepoint [8]

Week 0, 2, 4, 6, 8, 10, 12

Secondary outcome [9]

Energy intake by 3 day diet diary

Timepoint [9]

Week 0,2,4,6,8,10,12

Secondary outcome [10]

Urinary urea/creatinine ratio

Timepoint [10]

Week 0,2,4,6,8,10,12

Eligibility

Key inclusion criteria

- Type 2 diabetes, managed with diet or metformin alone
- HbA1c between 6.0% and 7.9% inclusive
- Body mass index 19-40
- Weight stable

Minimum age

18 Years

Maximum age

75 Years

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

- Significant gastrointestinal symptoms, or history of gastrointestinal disease
- Proteinuria
- Use of medications likely to affect gastrointestinal function

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)

No allocation concealment from the investigators

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

Online random number generator

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

Intervention assignment

Parallel

Other design features

Phase

Phase 2

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

3/11/2014

Actual

3/11/2014

Date of last participant enrolment

Anticipated

Actual

1/12/2016

Date of last data collection

Anticipated

Actual

1/03/2017

Sample size

Target

70

Accrual to date

Final

79

Recruitment in Australia

Recruitment state(s)

SA

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council of Australia

Address [1]

GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

University of Adelaide

Address

North Terrace
Adelaide SA 5000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Adelaide Hospital Human Research Ethics Committee

Ethics committee address [1]

Royal Adelaide Hospital North Terrace
Adelaide SA 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

06/01/2014

Ethics approval number [1]

313221

Summary

Brief summary

We are undertaking a randomised, placebo-controlled trial of a twice daily protein preload (20 g whey preload mixed with 5 g guar), taken before breakfast and dinner, to test the hypothesis that glycated haemoglobin (HbA1c) will be reduced by at least 0.5% compared to baseline at 12 weeks, in patients with type 2 diabetes who have relatively good glycaemic control (HbA1c less than or equal to 7.9%) on diet or metformin therapy alone. 

We will also test the secondary hypothesis that the whey preload (i) will induce slowing of gastric emptying, stimulation of incretin hormones and insulin, and reduce appetite and glycaemia after a standardised meal, and that these effects are sustained over 12 weeks; (ii) will induce greater reduction in HbA1c in subjects with more rapid gastric emptying at baseline; (iii) is not associated with weight gain, due to “compensation” for the increased protein load; and (iv) will reduce HbA1c independently of changes in insulin resistance, weight, or body composition.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Chris Rayner

Address

Discipline of Medicine Royal Adelaide Hospital North Terrace Adelaide SA 5000

Country

Australia

Phone

+61 8 82222916

Fax

Email

chris.rayner@adelaide.edu.au

Contact person for public queries

Name

Chris Rayner

Address

Discipline of Medicine Royal Adelaide Hospital North Terrace Adelaide SA 5000

Country

Australia

Phone

+61 8 82222916

Fax

Email

chris.rayner@adelaide.edu.au

Contact person for scientific queries

Name

Chris Rayner

Address

Discipline of Medicine Royal Adelaide Hospital North Terrace Adelaide SA 5000

Country

Australia

Phone

+61 8 82222916

Fax

Email

chris.rayner@adelaide.edu.au

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	A whey/guar "preload" improves postprandial glycaemia and glycated haemoglobin levels in type 2 diabetes: A 12-week, single-blind, randomized, placebo-controlled trial.	2019	https://dx.doi.org/10.1111/dom.13604
Embase	The 'early' postprandial glucagon response is related to the rate of gastric emptying in type 2 diabetes.	2023	https://dx.doi.org/10.1016/j.peptides.2023.170941
Dimensions AI	Serum alanine transaminase is predictive of fasting and postprandial insulin and glucagon concentrations in type 2 diabetes	2023	https://doi.org/10.1016/j.peptides.2023.171092

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