Clinical effectiveness of a synbiotic
| ISRCTN | ISRCTN37346212 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37346212 |
| Secondary identifying numbers | 311/2537 (IORG0006963) |
- 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
| 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 |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | 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 |
| Completion date | 31/01/2015 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
Sponsor information
Government
-
Astana
010000
Kazakhstan
| Phone | +7 (717) 274 2292 |
|---|---|
| Sara.Ualshina@edu.gov.kz | |
| Website | http://sc.edu.gov.kz/ |
"ROR" |
https://ror.org/03pj6ge82 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned submission to PLOS ONE and Nutrition journal (BMC). |
| 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 |
Editorial Notes
25/11/2020: Publication reference added.
