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Effects of Synbiotic Supplementation in Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Synbiotic
Placebo
Sponsored by
National Nutrition and Food Technology Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Synbiotic

    Placebo

    Arm Description

    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])

    250 mg Maltodexterin

    Outcomes

    Primary Outcome Measures

    HOMA-IR

    Secondary Outcome Measures

    Full Information

    First Posted
    December 8, 2013
    Last Updated
    December 10, 2013
    Sponsor
    National Nutrition and Food Technology Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02008838
    Brief Title
    Effects of Synbiotic Supplementation in Metabolic Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2012 (undefined)
    Primary Completion Date
    November 2012 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Nutrition and Food Technology Institute

    4. Oversight

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    38 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Synbiotic
    Arm Type
    Active Comparator
    Arm Description
    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])
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    250 mg Maltodexterin
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Synbiotic
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    HOMA-IR
    Time Frame
    28 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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: 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

    12. IPD Sharing Statement

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    Effects of Synbiotic Supplementation in Metabolic Syndrome

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