Clinical effectiveness of a synbiotic

The effect of a new synbiotic yoghurt “NAR” (???) in metabolic syndrome: a randomized, double-blind, placebo-controlled study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN37346212

Enrollment

180

Registered

2017-10-18

Start date

2014-08-01

Completion date

Unknown

Last updated

2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic syndrome Nutritional, Metabolic, Endocrine

Interventions

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:

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
No secondary outcome measures	—

Countries

Kazakhstan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 23, 2026