Clinical effectiveness of a synbiotic
| ISRCTN | ISRCTN37346212 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37346212 |
| Protocol serial number | 311/2537 (IORG0006963) |
| Sponsor | Committee of Science of the Ministry of Science and Education of the Republic of Kazakhstan |
| Funder | Committee of Science of the Ministry of Science and Education of the Republic of Kazakhstan |
- Submission date
- 12/10/2017
- Registration date
- 18/10/2017
- Last edited
- 25/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
53 Kabanbay batyr ave, 3422
Astana
010000
Kazakhstan
 ORCID ID |
0000-0001-9479-0899 |
|---|---|
| Phone | +77777727813 |
| akushugulova@nu.edu.kz |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized double-blind placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The effect of a new synbiotic yoghurt “NAR” (НӘР) in metabolic syndrome: a randomized, double-blind, placebo-controlled study |
| Study acronym | NAR |
| Study objectives | 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) |
| Health condition(s) or problem(s) studied | 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(s) |
Measured at baseline and day 90: |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 31/01/2015 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 180 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/08/2014 |
| Date of final enrolment | 15/09/2014 |
Locations
Countries of recruitment
- Kazakhstan
Study participating centre
Astana
010000
Kazakhstan
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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). |
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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
25/11/2020: Publication reference added.
