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CompletedNCT02008838Updated Dec 11, 2013

Effects of Synbiotic Supplementation in Metabolic Syndrome

A Phase 2/3 interventional study of Synbiotic and Placebo in Metabolic Syndrome, sponsored by National Nutrition and Food Technology Institute. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-11.

Sponsored by National Nutrition and Food Technology Institute · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

To evaluate the effects of synbiotic supplementation on insulin resistance, and lipid profile in subjects with metabolic syndrome, in a randomized, double-blind, placebo-controlled pilot study, 38 subjects with metabolic syndrome will be supplemented with either synbiotic or placebo capsules twice/day for 28 weeks. Both the synbiotic (G1) and the placebo (G2) groups will be advised to follow an energy balanced diet and physical activity recommendations. Parameters related to metabolic syndrome and insulin resistance will be measured every 7 weeks during the study course.

02

Conditions studied

  • Metabolic Syndrome
03

In context

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.

This study's enrollment of 38 is below the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

National Nutrition and Food Technology Institute is the lead sponsor of 62 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18 years of age and older
  • having three of the following five features: Increased waist circumference (≥102 cm in men and ≥88 cm in women), elevated TG (≥150 mg/dl), reduced HDL-C (≤40 mg/dl in men and ≤50 mg/dl in women), elevated blood pressure (≥130/85 mm Hg or on treatment for hypertension) and elevated glucose (≥100 mg/dl), according to the National Cholesterol Education Program Adult Treatment Panel III report
  • BMI : 25≥ BMI ≥ 40

Exclusion criteria

Exclusion Criteria:

  • Use antibiotic 2 weeks before recruitment to the study
  • A history of alcohol consumption
  • Pregnancy \& Breast feeding , Professional athelets
  • A history of Cardiovascular disease, Pulmonary disease, Renal disease \& Celiac disease
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
38 participants (actual)

Study arms

  • Active comparator
    Synbiotic

    Each synbiotic capsule (Protexin, UK) contained 2 × 108 CFU of seven strains of friendly bacteria (Lactobacillus casei, Lactobacillus rhamnosus, Streptococcus thermophilus, Bifidobacterium breve, Lactobacillus acidophilus, Bifidobacterium longum, Lactobacillus bulgaricus), prebiotics (FOS \[Fructooligosaccharide\]), and probiotics culture (Magnesium stearate \[source: mineral and vegetable\], and vegetable capsule \[hydroxypropyl methyl cellulose\])

    Dietary Supplement: Synbiotic

  • Placebo comparator
    Placebo

    250 mg Maltodexterin

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementSynbiotic
  • Dietary supplementPlacebo
06

What researchers measure

Primary outcomes

  1. HOMA-IR

    Time frame: 28 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02008838
Lead sponsor
National Nutrition and Food Technology Institute
Responsible party
Dr Azita Hekmatdoost (Assisstant Prof, National Nutrition and Food Technology Institute) — Principal investigator
First posted
Dec 11, 2013
Start date
Apr 2012
Primary completion
Nov 2012
Last update
Dec 11, 2013
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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