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Trial registered on ANZCTR


Registration number
ACTRN12613001118796
Ethics application status
Approved
Date submitted
20/09/2013
Date registered
4/10/2013
Date last updated
4/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intervention with diet rich in two types of dietary fibre on glycemia, adipokines and lipid status in obese pre-diabetic subjects
Scientific title
Examination of influence of the total dietary fibre and resistant starch on decreasing risk factors for type 2 diabetes mellitus in obese patients with disorders of glucoregulation
Secondary ID [1] 283339 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 290138 0
Diabetes
 290240 0
Disorders of glucoregulation 290241 0
Condition category
Condition code
Metabolic and Endocrine 290528 290528 0 0
Diabetes
Diet and Nutrition 290632 290632 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study was focused on the influence of high-carbohydrate, high fibre and low-fat diet on glycemic level, body weight, body mass index, lipid status and adipokines in obese subjects with impaired glycoregulation. The idea of this study was to compare the difference in the overall effect of foods rich dietary fibre with predefined resistant starch content (total fiber intake of 25-30 g/day of which resistant starch comprised 15 g; diet 1) and foods rich in total dietary fibre (total fiber intake of 25 – 35 g/daily, but the amount of resistant starch was not important; diet 2) on the above parameters.
The subjects in both groups at the beginning get instruction to include food rich in fibre such as vegetables, wholegrain cereals, and fruit, but also low-fat dairy products, low-fat meat such as poultry and fish. Participants who adhered to the dietary regimen 1 get instruction to take following foods as sources of resistant starch: cooked rice, cooked potatoes, cooked beans, cooked peas, cooked lentils, cooked millet, pasta, palenta, rye and barley flakes, pumpkin pie, potato pie, pearl barley, sweet corn, sourdough bread, rye bread and green bananas.
Participants of group 1 and 2 of this study should keep 12 months's recommended diet regime.
Dietary advices were gave on the participants by me and doctor-endocrinologist.
Once in a month all participants were educated about importance of the recommended diet. Also, an open forum discussions were organized where the participants had the opportunity to exchange their experiences and difficulties with practical advices how to overcome the problems.
At the beginning and after 12 months, on all subjects were performed anthropometric measurements, blood pressure measurements, oral glucose tolerance test, and blood samples were taken for analysis of lipids and adipokines. Also, dietary intake was assessed using 3-day food records at the start and after 12 months.
Intervention code [1] 287993 0
Lifestyle
Intervention code [2] 288067 0
Prevention
Comparator / control treatment
The only difference in diets between the subjects from intervention and control group was in fibre type. Dietary regimen 1 (intervention group) was tailored to achieve total fiber intake of 25-30 g/day of which resistant starch comprised 15 g. Dietary regimen 2 (control group) favorized the same total fiber intake of 25 – 35 g/daily, but the amount of resistant starch was not important
Control group
Active

Outcomes
Primary outcome [1] 290553 0
Normalization of blood glucose level i.e. fasting glucose level less than 6.1 mmol / L and glucose level after 2-h OGTT less than 7,8 mmol/L
Timepoint [1] 290553 0
Study exists 12 months
Primary outcome [2] 290554 0
Changes in body weight at the beginning and after 12 month were monitored by measuring on calibratied digital scale
Timepoint [2] 290554 0
Study exists 12 months
Secondary outcome [1] 304779 0
Blood samples from subjects at the beginning and after 12 month were taken after a 12-hour fast between 8:30 AM and 10:30 AM, and serum was immediately frozen at -80 degrees Celsius for further biochemical analysis. Cholesterol level was determined from serum of routine automated methods using an OLYMPUS AU680
Timepoint [1] 304779 0
Study exists 12 months

Eligibility
Key inclusion criteria
Obesity and overweight subjects and disorders of glucoregulation
Minimum age
45 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Normal glycoregulation

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/09/2010
Actual
18/09/2012
Date of last participant enrolment
Anticipated
Actual
17/10/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 5463 0
Serbia and Montenegro
State/province [1] 5463 0

Funding & Sponsors
Funding source category [1] 288004 0
University
Name [1] 288004 0
Faculty of Pharmacy, University of Belgrade
Country [1] 288004 0
Serbia and Montenegro
Primary sponsor type
Individual
Name
Brizita Djordjevic
Address
University of Belgrade, Faculty of Pharmacy, Vojvode Stepe 450, Belgrade
Country
Serbia and Montenegro
Secondary sponsor category [1] 286726 0
None
Name [1] 286726 0
Address [1] 286726 0
Country [1] 286726 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 43126 0
Prof Brizita I. Djordjevic
Address 43126 0
University of Belgrade, Faculty of Pharmacy, Vojvode Stepe 450 Belgrade
Country 43126 0
Serbia and Montenegro
Phone 43126 0
+381113951393
Fax 43126 0
Email 43126 0
briz@pharmacy.bg.ac.rs
Contact person for public queries
Name 43127 0
Margarita S. Dodevska
Address 43127 0
"Food Research Centre", Zmaja od Nocaja 11, Belgrade
Country 43127 0
Serbia and Montenegro
Phone 43127 0
+381112625077
Fax 43127 0
Email 43127 0
margarita@cin.co.rs
Contact person for scientific queries
Name 43128 0
Margarita S. Dodevska
Address 43128 0
"Food Research Centre", Zmaja od Nocaja 11, Belgrade
Country 43128 0
Serbia and Montenegro
Phone 43128 0
+381112625077
Fax 43128 0
Email 43128 0
margarita@cin.co.rs

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
SourceTitleYear of PublicationDOI
EmbaseEffects of total fibre or resistant starch-rich diets within lifestyle intervention in obese prediabetic adults.2016https://dx.doi.org/10.1007/s00394-015-0831-3
N.B. These documents automatically identified may not have been verified by the study sponsor.