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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Obesity

Diabetes

Disorders of glucoregulation

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Diet and Nutrition

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]

Lifestyle

Intervention code [2]

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]

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]

Study exists 12 months

Primary outcome [2]

Changes in body weight at the beginning and after 12 month were monitored by measuring on calibratied digital scale

Timepoint [2]

Study exists 12 months

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Serbia and Montenegro

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Faculty of Pharmacy, University of Belgrade

Address [1]

Vojvode Stepe 450, Belgrade

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Summary

Brief summary

Diet rich with fibre and modified diet rich with resistant starch  may be significantly effective in prevention and suppression of chronic diseases.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Brizita I. Djordjevic

Address

University of Belgrade, Faculty of Pharmacy, Vojvode Stepe 450 Belgrade

Country

Serbia and Montenegro

Phone

+381113951393

Fax

[email protected]

Contact person for public queries

Name

Margarita S. Dodevska

Address

"Food Research Centre", Zmaja od Nocaja 11, Belgrade

Country

Serbia and Montenegro

Phone

+381112625077

Fax

[email protected]

Contact person for scientific queries

Name

Margarita S. Dodevska

Address

"Food Research Centre", Zmaja od Nocaja 11, Belgrade

Country

Serbia and Montenegro

Phone

+381112625077

Fax

[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

Source	Title	Year of Publication	DOI
Embase	Effects of total fibre or resistant starch-rich diets within lifestyle intervention in obese prediabetic adults.	2016	https://dx.doi.org/10.1007/s00394-015-0831-3

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

Trial Review

Documents added manually

Documents added automatically