Clinical effectiveness of a synbiotic

• Register: ISRCTN
• Last refreshed on: 7 December 2020
• Main ID: ISRCTN37346212
• Date of registration: 18/10/2017
• Prospective Registration: No
• Primary sponsor: Committee of Science of the Ministry of Science and Education of the Republic of Kazakhstan
• Public title: Clinical effectiveness of a synbiotic
• Scientific title: The effect of a new synbiotic yoghurt “NAR” (???) in metabolic syndrome: a randomized, double-blind, placebo-controlled study
• Date of first enrolment: 01/08/2014
• Target sample size: 180
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN37346212
• Study type: Interventional
• Study design: Randomized double-blind placebo-controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Kazakhstan

Contacts

• Name: Almagul Kushugulova

Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Metabolic syndrome
Nutritional, Metabolic, Endocrine

Intervention(s)

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.

Primary Outcome(s)

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(s)

No secondary outcome measures

Secondary ID(s)

311/2537 (IORG0006963)

Source(s) of Monetary Support

Committee of Science of the Ministry of Science and Education of the Republic of Kazakhstan

Ethics review

Status:
Approval date:
Contact:

Ethics Committee of the Center for Life Sciences National Laboratory Astana Nazarbayev University, 04/04/2012, ref: 311/2537 (IORG0006963)

Results

• Results available: Yes
• Date Completed: 31/01/2015