Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001060033
Ethics application status
Approved
Date submitted
20/05/2010
Date registered
2/12/2010
Date last updated
17/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of glycaemic load on satiety
Scientific title
The effect of a low glycaemic load diet and a high glycaemic load diet, matched for macronutrient level and type of fibre, on glucose and satiety over a 12 hour period in healthy adult males.
Secondary ID [1] 251775 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Satiety 257417 0
Condition category
Condition code
Diet and Nutrition 257566 257566 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diet varying in glycaemic load (one high (GL= 206), one low (GL=126) fed over 12 hour period. Diets consisted of everyday food items. The high GL diet included white bread, jam, lucozade, pizza, macaroni cheese whilst the low GL diet consised of soy and linseed bread, milo, cheese, hummus, salad, falafel, yoghurt, fruit). Meals will be given at 08.00 (breakfast), 10.00 (morning tea), 13.00 (lunch), 15.00 (afternoon tea) and 18.00 (dinner). Measurements of blood glucose levels; satiety (visual analogue scales);mood (state trait anxiety scales); cognitive function (mini mental state exam) were made through the course of the day. As this is a cross over study, participants will have a period of at least 7 days between each visit.
Intervention code [1] 256473 0
Lifestyle
Intervention code [2] 256521 0
Behaviour
Comparator / control treatment
Low versus high glycaemic load diet
Control group
Active

Outcomes
Primary outcome [1] 258428 0
Effect on feelings of satiety (fullness) measured by visual analogue scales
Timepoint [1] 258428 0
0, 30, 60, 90,120, 150, 180, 210, 240, 300, 330, 360, 390, 420, 450, 480, 510, 540, 600, 630, 660, 720 min
Primary outcome [2] 258429 0
Effect on cognitive function assessed using the serial sevens testing and word recall testing
Timepoint [2] 258429 0
0, 30, 60, 90,120, 150, 180, 210, 240, 300, 330, 360, 390, 420, 450, 480, 510, 540, 600, 630, 660, 720 min
Primary outcome [3] 258430 0
Effect on mood/mental state assessed using the state trait anxiety scale
Timepoint [3] 258430 0
0, 30, 60, 90,120, 150, 180, 210, 240, 300, 330, 360, 390, 420, 450, 480, 510, 540, 600, 630, 660, 720 min
Secondary outcome [1] 264208 0
Blood glucose response to diets
Timepoint [1] 264208 0
0, 30, 60, 90,120, 150, 180, 210, 240, 300, 330, 360, 390, 420, 450, 480, 510, 540, 600, 630, 660, 720 min

Eligibility
Key inclusion criteria
Subjects will be healthy male individuals (age 18-45) with healthy weight (Body mass index , BMI, 19-25 kg/m2) and normal glucose tolerance (fasting glucose < 5.6 mmol/L). Exclusion criteria will include: smoking, medication, food allergy/intolerance, dieting, physical or mental illness
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria include: smoking, medication, food allergy/intolerance, dieting, physical or mental illness

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)
Participants will be required to visit the clinic for an introductory interview. This visit will be to establish their suitability for the trial and to gain consent. Following a discussion about the trial, participants will be asked to fill out a questionnaire designed to assess their motivation to eat, i.e the Dutch Eating Behaviour Questionnaire to assess issues which may affect adequate food intake and body weight control. Following their inclusion into the study, particpants will be allocated a unique idenifier code and will be randomly allocated to the first dietary intevention (low or high glycaemic load (GL) diet). following completion of this they will then cross over to the remaining diet for the second twelve hour intervention after a seven day washout period. Particpants will be allocated to the diets using Microsoft EXCEL randomisation procedure
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The 24 participants will be randomly assigned to consume the low GL or high GL diet once on each of the two visits to the clinic. Participants will not be informed which diet they will be consuming on which day. Participants will be randomly assigned using random number tables.
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
14/06/2010
Actual
5/07/2010
Date of last participant enrolment
Anticipated
Actual
16/07/2010
Date of last data collection
Anticipated
Actual
20/12/2010
Sample size
Target
24
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 2628 0
New Zealand
State/province [1] 2628 0
Christchurch

Funding & Sponsors
Funding source category [1] 257006 0
Other Collaborative groups
Name [1] 257006 0
Lifestyle Foods
Country [1] 257006 0
New Zealand
Primary sponsor type
Other Collaborative groups
Name
Lifestyle Foods
Address
Plant and Food Research
Po Box 4704
Christchurch
8140
Country
New Zealand
Secondary sponsor category [1] 256268 0
Government body
Name [1] 256268 0
Foundation for research Science and Technology
Address [1] 256268 0
Level 11
AT&T Tower
15-17 Murphy Street
Thorndon
Wellington
6011
Country [1] 256268 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259025 0
Upper South A Regional Ethics Committee
Ethics committee address [1] 259025 0
Ethics committee country [1] 259025 0
New Zealand
Date submitted for ethics approval [1] 259025 0
31/03/2010
Approval date [1] 259025 0
07/05/2010
Ethics approval number [1] 259025 0
URA/10/04/032

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

Contacts
Principal investigator
Name 31163 0
Ms Sarah Eady
Address 31163 0
Plant and Food Research
Gerald Street
Lincoln
Christchurch 7608
Country 31163 0
New Zealand
Phone 31163 0
64 3 3259671
Fax 31163 0
Email 31163 0
[email protected]
Contact person for public queries
Name 14410 0
Sarah Eady
Address 14410 0
Plant and Food Research
Gerald Street
Lincoln
Christchurch
PO Box 4704
8140
Country 14410 0
New Zealand
Phone 14410 0
64 3 3259671
Fax 14410 0
64 3 325 2074
Email 14410 0
[email protected]
Contact person for scientific queries
Name 5338 0
Sarah Eady
Address 5338 0
Plant and Food Research
Gerald Street
Lincoln
Christchurch
PO Box 4708140
Country 5338 0
New Zealand
Phone 5338 0
64 3 3259671
Fax 5338 0
64 3 325 2074
Email 5338 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.