Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000469617
Ethics application status
Approved
Date submitted
6/09/2005
Date registered
23/09/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of a low glycemic load diet, comprised of higher levels of protein and low glycemic index foods, on the severity of acne symptoms
Scientific title
The effect of a low glycemic load diet, comprised of higher levels of protein and low glycemic index foods, on the severity of acne symptoms in young males.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acne vulgaris 588 0
Condition category
Condition code
Skin 660 660 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This pilot study compared the therapeutic potential of a low glycemic load diet, comprised of higher levels of protein and low glycemic index foods, with a control diet (no intervention). The intervention diet consisted on 25% energy from protein, 45% energy from low glycemic index carbohydrates, and 30% energy from fats. Diets were isocalorically matched with baseline and the intervention period was for 12-weeks.
Intervention code [1] 380 0
None
Comparator / control treatment
The control group did not receive any information about diet, nor any dietary instruction.
Control group
Active

Outcomes
Primary outcome [1] 785 0
Percentage change in acne counts (with respect to baseline)
Timepoint [1] 785 0
Dermatological examinations were performed by a dermatologist at baseline and at monthly intervals for the three-month study duration
Primary outcome [2] 786 0
Severity change
Timepoint [2] 786 0
Dermatological examinations were performed by a dermatologist at baseline and at monthly intervals for the three-month study duration
Primary outcome [3] 787 0
Total lesion change
Timepoint [3] 787 0
Dermatological examinations were performed by a dermatologist at baseline and at monthly intervals for the three-month study duration
Primary outcome [4] 788 0
Inflammatory lesion change
Timepoint [4] 788 0
Dermatological examinations were performed by a dermatologist at baseline and at monthly intervals for the three-month study duration
Secondary outcome [1] 1595 0
Blood tests were performed to identify any changes in hormonal markers of acne.
Timepoint [1] 1595 0
At baseline and 12-weeks.

Eligibility
Key inclusion criteria
Facial acne. Participants were required to have acne for longer than 6-months prior to recruitment.
Minimum age
15 Years
Maximum age
25 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
People were excluded if they were taking medications known to effect either acne or glucose metabolism (a wash-out period of 6 months was required for oral retinoids or 2-months required for oral antibiotics or topical antibacterial /retinoid agents).

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)
Sequence generation and allocation were performed by a third party staff member and were concealed from the investigator until after the participant enrolment. The method involved creation of a numbered list of 1 to 100, then random number generation. Even and odd numbers were indicative of test group and control group respectively and were entered on the list as they were generated, prior to recruitment of any subjects. The third party staff member not involved with the conduct of the study entered recruits on the list in order of recruitment and revealed their designated group to the investigator following completion of recruitment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation was by random-generated numbers using computer software (excel)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
54
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 730 0
Commercial sector/Industry
Name [1] 730 0
Meat and Livestock Australia
Country [1] 730 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Meat and Livestock Australia
Address
Country
Australia
Secondary sponsor category [1] 605 0
Commercial sector/Industry
Name [1] 605 0
Mintrac (student stipend)
Address [1] 605 0
Country [1] 605 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35122 0
Address 35122 0
Country 35122 0
Phone 35122 0
Fax 35122 0
Email 35122 0
Contact person for public queries
Name 9569 0
Robyn Smith
Address 9569 0
Food Science Department
Royal Melbourne Instiute of Technology (RIMT) University
GPO Box 2476V
Melbourne VIC 3001
Country 9569 0
Australia
Phone 9569 0
+61 3 99252720
Fax 9569 0
Email 9569 0
[email protected]
Contact person for scientific queries
Name 497 0
Associate Professor, Dr Neil Mann
Address 497 0
Food Science Department
Royal Melbourne Instiute of Technology (RIMT) University
GPO Box 2476V
Melbourne VIC 3001
Country 497 0
Australia
Phone 497 0
+61 3 99255095
Fax 497 0
Email 497 0
[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
No additional documents have been identified.