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The Effect of Probiotic/Synbiotic on Indices of Metabolic Syndrome in Prediabetics

Evaluation and Comparison of probiotics and Synbiotics on Metabolic Indices in Prediabetics: Controlled Randomized Triple Blind Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201511032321N2
Enrollment
120
Registered
2016-02-27
Start date
2016-04-20
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

prediabetes(impaired glucose tolerance). Malnutrition-related diabetes mellitus

Interventions

Intervention 1: Intervention 1 :probiotic supplement in form of 6g/d sachet diluted in water after main meal for 6 months Intervention. Intervention 2: control: 6g/d maltodextrin in the form of sache
Treatment - Drugs
Placebo
Intervention 1 :probiotic supplement in form of 6g/d sachet diluted in water after main meal for 6 months Intervention
control: 6g/d maltodextrin in the form of sachet after main meal diluted in 250cc water for 6 months
Intervention2:6g/d synbiotic(inulin+probiotic) in the form of sachet after the main meal diluted in 250cc water for 6 months.

Sponsors

Isfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria:Being prediabetes (FBS:100-125 OR 2hBS:140-200); consent to cooperation in the study;not having gastrointestinal disorders (seliac,IBD);not consume pro/pre/anti biotics during the last 3 months; not consume corton/anti psycose/nicotinic acid. Exclusion Criteria:Stop adherence to the study .

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
FBS. Timepoint: 0-3-6-12-18 months. Method of measurement: GOD method by Pars Azmoon kit.;HDL. Timepoint: 0-3-6-12-18 months. Method of measurement: photometric assay by Pars Azmoon kit.;TG. Timepoint: 0-3-6-12-18 months. Method of measurement: photometric assay by Pars Azmoon kit.;CHOL. Timepoint: 0-3-6-12-18 months. Method of measurement: photometric assay by Pars Azmoon kit.;LDL. Timepoint: 0-3-6-12-18 months. Method of measurement: photometric assay by Pars Azmoon kit.;HbA1C. Timepoint: 0-3-6-12-18 months. Method of measurement: Ion exchange chromatography.;Serum Insulin. Timepoint: 0-3-6-12-18 months. Method of measurement: chemo iuminesense by Zimense kit.;Insulin resistance. Timepoint: 0-3-6-12-18 months. Method of measurement: HOMA-IR.;B-cell function. Timepoint: 0-3-6-12-18 months. Method of measurement: HOMA-B.;Weight. Timepoint: 0-3-6-12-18 months. Method of measurement: scale-mounted stadiometer(Seca).;Height. Timepoint: 0-3-6-12-18 months. Method of measurement: scale-mounted stadiometer(Seca).;Waist circumference. Timepoint: 0-3-6-12-18 months. Method of measurement: flexible tape.;Hip circumference. Timepoint: 0-3-6-12-18 months. Method of measurement: flexible tape.;BMI. Timepoint: 0-3-6-12-18 months. Method of measurement: Weight (kg)/Height (m) 2.;WHR. Timepoint: 0-3-6-12-18 months. Method of measurement: Waist circumference (cm)/Hip circumference (cm).—

Secondary

MeasureTime frame
Food energy content. Timepoint: 0-3-6-12-18 months. Method of measurement: food dairy record questionare.;Food micronutrient content. Timepoint: 0-3-6-12-18 months. Method of measurement: food dairy record questionare.;Food maicronutrient content. Timepoint: 0-3-6-12-18 months. Method of measurement: food dairy record questionare.;Energy content from physical activity. Timepoint: 0-3-6-12-18 months. Method of measurement: METs questionare.—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNazila Kassaian

Isfahan endocrin and Metabolism Research center

EMRC@mui.ac.ir , kasaeian@idrc.mui.ac.ir+98 31 3337 9090

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 6, 2026