Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000248662
Ethics application status
Approved
Date submitted
29/08/2005
Date registered
31/08/2005
Date last updated
8/06/2021
Date data sharing statement initially provided
8/06/2021
Date results information initially provided
8/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Meal Replacement Study
Scientific title
Study of Meal Replacement with Formula Diet in achieving weight loss and improved metabolic control in people with type 2 diabetes
Secondary ID [1] 304434 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 335 0
Condition category
Condition code
Metabolic and Endocrine 387 387 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to either group A (diet) or B (meal replacement) for a period of six months. Group A will receive conventional low calorie diet and physical activity guidance once per month during the six months and Group B will receive the same advice and in addition replace one meal each day with a meal replacement, Microdiet (MD).
Intervention code [1] 292 0
Lifestyle
Comparator / control treatment
Conventional low calorie diet and physical activity guidance once per month
Control group
Active

Outcomes
Primary outcome [1] 444 0
Change in body weight between baseline and 6 months.
Timepoint [1] 444 0
Change in body weight between baseline and 6 months
Secondary outcome [1] 975 0
Change in metabolic control of diabetes
Timepoint [1] 975 0
At three and six months as measured by HbA1C%, blood pressure and lipids (TG, TC, HDL-C & LDL-C).

Eligibility
Key inclusion criteria
Type 2 diabetes. Body mass index > 29kg/m2.
Minimum age
30 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe underlying disease prohibiting low calorie diet therapyAllergy to MDPregnant or breastfeedingNeed for protein restrictionGP considers the participant inappropriate.

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)
Sealed envelopes are held by an independent person, and opened by the independent person to assign the intervention group
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random numbers (using Microsoft Excel), in blocks of 2-8 are used. These are stratified by diabetes treatment modality into 2 strata - insulin or non-insulin controlled.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/06/2005
Actual
21/06/2005
Date of last participant enrolment
Anticipated
Actual
1/08/2005
Date of last data collection
Anticipated
Actual
1/03/2006
Sample size
Target
40
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 439 0
Commercial sector/Industry
Name [1] 439 0
Sunny Health Co.
Country [1] 439 0
Japan
Primary sponsor type
Commercial sector/Industry
Name
Sunny Health Co., Japan
Address
Yaesu Center Bldg, 5F, 1-6-6 Yaesu
Chuo-ku, Tokyo, Japan 103-0028
Country
Japan
Secondary sponsor category [1] 357 0
None
Name [1] 357 0
None
Address [1] 357 0
Country [1] 357 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1412 0
International Diabetes Institute
Ethics committee address [1] 1412 0
Ethics committee country [1] 1412 0
Australia
Date submitted for ethics approval [1] 1412 0
Approval date [1] 1412 0
21/03/2005
Ethics approval number [1] 1412 0

Summary
Brief summary
Mean (± SEM) weight loss adjusted for baseline values was significantly greater in the meal replacement group (n=20) than the control group (n=21) at three months (4.7± 0.8 vs 1.3 ± 0.8 kg, P=0.007) and at six months (5.0± 5.2 vs 1.5± 5.2 kg, P=0.04) (Figure 1). The reduction in waist circumference was 1.4 cm greater in the meal replacement group than the control group at six months, but this difference was not significant. BMI reduced by 1.8kg/m2 in the meal replacement group and by 0.6kg/m2 in the control group (P=0.05).
Trial website
Trial related presentations / publications
No publication.
Public notes

Contacts
Principal investigator
Name 36116 0
A/Prof Jonathan Shaw
Address 36116 0
Baker IDI Heart and Diabetes Institute
99 Commercial Road
Melbourne 3004
Country 36116 0
Australia
Phone 36116 0
+61 3 8532 1821
Fax 36116 0
Email 36116 0
jonathan.shaw@bakeridi.edu.au
Contact person for public queries
Name 9481 0
Miss Miss Cathie Adams
Address 9481 0
International Diabetes Institute
250 Kooyong Road
Caulfield VIC 3162
Country 9481 0
Australia
Phone 9481 0
+61 3 92585000
Fax 9481 0
Email 9481 0
cadams@idi.org.au
Contact person for scientific queries
Name 409 0
A/Prof Associate Professor Jonathan Shaw
Address 409 0
Baker IDI Heart and Diabetes Institute
99 Commercial Road
Melbourne 3004
Country 409 0
Australia
Phone 409 0
+61 3 8532 1821
Fax 409 0
Email 409 0
jonathan.shaw@bakeridi.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.