Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/10/2017
Date assigned
18/10/2017
Last edited
18/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Hospitals

Trial 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

Phase

Drug names

Primary outcome measures

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 trial start date

03/01/2012

Overall trial end date

31/01/2015

Reason abandoned

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

Mixed

Age group

Adult

Gender

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

Trial 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

http://sc.edu.gov.kz/

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).

IPD sharing statement
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).

Intention to publish date

31/12/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes