Plain English Summary
Background and study aims
This study is the first large study of probiotics in Kazakhstan and the first study on the new synbiotic yoghurt NAR. The uniqueness of this product lies in the fact that it consists of probiotic component strains isolated from a traditional Kazakh koumiss product. The aim of this study is to find out whether this synbiotic yoghurt can be used in the treatment of metabolic disorders such as obesity and diabetes.
Who can participate?
Patients with metabolic syndrome and healthy volunteers, aged 25 to 75
What does the study involve?
The participants are randomly allocated to take two cups (200 g) a day of a synbiotic yogurt or a placebo (without any prebiotic components) for 3 months. Body measurements, blood pressure, heart rate, blood and faeces samples, and stool consistency and frequency are assessed at the start of the study and at 90 days.
What are the possible benefits and risks of participating?
There are only minimal risks for patients associated with the stool sampling procedures.
Where is the study run from?
Medical Center under the Office of the Kazakh President (Kazakhstan)
When is the study starting and how long is it expected to run for?
January 2012 to January 2015
Who is funding the study?
Committee of Science of the Ministry of Science and Education of the Republic of Kazakhstan
Who is the main contact?
Dr Almagul Kushugulova
akushugulova@nu.edu.kz
Study website
Contact information
Type
Scientific
Contact name
Dr Almagul Kushugulova
ORCID ID
http://orcid.org/0000-0001-9479-0899
Contact details
53 Kabanbay batyr ave
3422
Astana
010000
Kazakhstan
+77777727813
akushugulova@nu.edu.kz
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
311/2537 (IORG0006963)
Study information
Scientific title
The effect of a new synbiotic yoghurt “NAR” (НӘР) in metabolic syndrome: a randomized, double-blind, placebo-controlled study
Acronym
NAR
Study hypothesis
The intake of this synbiotic yoghurt as an auxiliary in the treatment of metabolic disorders such as obesity, insulin resistance, diabetes mellitus and their comorbidities is highly effective.
Ethics approval(s)
Ethics Committee of the Center for Life Sciences National Laboratory Astana Nazarbayev University, 04/04/2012, ref: 311/2537 (IORG0006963)
Study design
Randomized double-blind placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Metabolic syndrome
Intervention
Enrolled patients (either with metabolic syndrome or healthy) were randomly allocated to the synbiotic group or the placebo group, respectively. After analysis the groups were labeled as follows:
(A) Metabolic syndrome - synbiotic
(B) Metabolic syndrome – placebo
(C) Healthy – synbiotic
(D) Healthy – placebo
The participants will take two cups (200 g) a day for three months of either synbiotic yogurt or placebo. The participants of all groups received similar counseling for lifestyle modification regarding dietary habits.
Intervention type
Other
Primary outcome measure
Measured at baseline and day 90:
1. Cardiovascular status (systolic and diastolic blood pressure, heart rate)
2. Stool consistency assessed according to the Bristol Stool Form Scale (BSS)
3. Stool frequency assessed on a 5-point scale
4. Blood samples collected for genomic studies
5. Stool samples collected for metagenomic studies
6. Body weight measured with a digital floor scale with 100 g accuracy, without shoes and with minimum clothing
7. Height measured to 1 mm accuracy with a non-elastic tape
8. Waist circumference measured with a non-elastic tape at a point midway between the lower border of the rib cage and the iliac crest at the end of normal expiration
9. Hip circumference measured with a non-elastic tape at the maximum girth of the buttocks
10. Blood glucose, glycosylated hemoglobin, total cholesterol, LDL, HDL, Triglycerides, C-reactive protein, hemoglobin, erythrocytes, leukocytes, platelets, and ESR, measured with standard procedures using blood samples taken from the antecubital vein
11. Issues related to nutrition, general health, past illnesses, as well as marital status, parenthood and education, assessed using questionnaire. The questions related to nutrition included a comprehensive list of different kinds food and meals adapted according to common Kazakh dietary habits. These data were converted to macro- and micronutrient quantifications.
Secondary outcome measures
No secondary outcome measures
Overall study start date
03/01/2012
Overall study end date
31/01/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. No history of the use of probiotics or antibiotics for 3 months
2. Blood pressure: = 130/90 mmHg
3. Raised fasting plasma glucose (FPG): >100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes
4. Dyslipidemia TG: = 1.695 mmol/L; HDL-C = 0.9 mmol/L (male), = 1.0 mmol/L (female)
5. Central obesity: waist:hip ratio > 0.90 (male); > 0.85 (female), or body mass index > 30 kg/m2
Participant type(s)
Mixed
Age group
Adult
Sex
Both
Target number of participants
180
Participant exclusion criteria
1. Acute illness or fever at the time of recruitment
2. Positive for HIV, hepatitis B or C, or for human papillomavirus (HPV)
3. Had anamnesis for surgery of the gastrointestinal tract, including any bowel resection
4. Pregnant or breastfeeding
5. Participants who had used the following medications during the last 6 months: antibiotics, antifungal, antiviral or antiparasitic drugs; corticosteroids; cytokines; commercial probiotics; or vaccines
Recruitment start date
01/08/2014
Recruitment end date
15/09/2014
Locations
Countries of recruitment
Kazakhstan
Study participating centre
Medical Center under the Office of the Kazakh President
Astana, 80 Mangylyk el ave
Astana
010000
Kazakhstan
Sponsor information
Organisation
Committee of Science of the Ministry of Science and Education of the Republic of Kazakhstan
Sponsor details
-
Astana
010000
Kazakhstan
+7 (717) 274 2292
Sara.Ualshina@edu.gov.kz
Sponsor type
Government
Website
ROR
Funders
Funder type
Government
Funder name
Committee of Science of the Ministry of Science and Education of the Republic of Kazakhstan
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned submission to PLOS ONE and Nutrition journal (BMC).
Intention to publish date
31/12/2017
Individual participant data (IPD) sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Almagul Kushugulova (akushugulova@nu.edu.kz).
IPD sharing plan summary
Available on request
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | gut microbial analysis results | 28/07/2018 | 25/11/2020 | Yes | No |