Intervention with diet rich in two types of dietary fibre on glycemia, adipokines and lipid status in obese pre-diabetic subjects

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12613001118796
• Date of registration: 04/10/2013
• Prospective Registration: No
• Primary sponsor: Brizita Djordjevic
• 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
• Date of first enrolment: 18/09/2012
• Target sample size: 50
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12613001118796.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial;

Countries of recruitment

Serbia and Montenegro

Contacts

• Name: Miss Margarita S. Dodevska

• Name: Miss Margarita S. Dodevska

Key inclusion & exclusion criteria

Inclusion criteria: Obesity and overweight subjects and disorders of glucoregulation
Exclusion criteria: Normal glycoregulation

Age minimum: 45 Years
Age maximum: 74 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Obesity;Diabetes ;Disorders of glucoregulation;
Obesity
Diabetes

Disorders of glucoregulation

Diet and Nutrition - Obesity

Metabolic and Endocrine - Diabetes

Intervention(s)

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,

Primary Outcome(s)

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[Study exists 12 months]

Changes in body weight at the beginning and after 12 month were monitored by measuring on calibratied digital scale[Study exists 12 months]

Secondary Outcome(s)

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[Study exists 12 months]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Faculty of Pharmacy, University of Belgrade