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The effects of probiotic supplement on patients with metabolic syndrome

Comparison of the effects of probiotic supplement with placebo on anthropometric measurements, metabolic syndrome components, gastrointestinal hormones and inflammatory factors in patients with metabolic syndrome in Tehran

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013111115368N1
Enrollment
46
Registered
2014-01-03
Start date
2014-01-10
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

metabolic syndrome. Disorders of lipoprotein metabolism and other lipidaemias, Obesity, Other specified diabetes mellitusHypertensive heart disease

Interventions

Intervention 1: The intervention group will consume 2 probiotic capsules for 3 months(each white capsule has 250 mg weight , by PROTEXIN). This group will receive a weight loss diet, according to the
Placebo
The intervention group will consume 2 probiotic capsules for 3 months(each white capsule has 250 mg weight , by PROTEXIN). This group will receive a weight loss diet, according to the adjusted ideal b
The placebo group will consume 2 placebo capsules for 3 months which will produce by PROTEXIN similar to probiotic capsules, including maltodextrin. This group will receive a weight loss diet, accordi

Sponsors

National Nutrition and Food Sciences Technology Research Institut
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: To be volunteer to participate in this study; Patients with diagnosis of metabolic syndrome; Aged 25-70; To have a BMI =25kg/m2; Not smoking, pregnant and lactating; Without a diagnosis of thyroid disorders; Not taking medication including: multivitamin-mineral supplements, omega-3, oral contraceptive peel, estrogen, progesterone, corticosteroids or Insulin; Not consuming green tea and fiber powder; Not being a vegetarian or follower of unusual dietary patterns from before the study; Not taking any kind of antibiotic drugs from 1 month before the study. Exclusion criteria: Taking Antibiotic during study; Consuming energy less than 800 or more than 4200 Kcal/day; Consuming less than 2/3 of probiotic supplement; Missing any inclusion criteria during the study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Triglycerid. Timepoint: in the begining and after 3 month. Method of measurement: enzymatic method.;Fasting glucose. Timepoint: in the begining and after 3 month. Method of measurement: enzymatic method.;HDL. Timepoint: in the begining and after 3 month. Method of measurement: enzymatic method.;Waist circumference. Timepoint: in the begining, after 1 month, after 2 month and after 3 month. Method of measurement: meter.;Systolic and diastolic pressure. Timepoint: in the begining and after 3 month. Method of measurement: barometer.;Hs-CRP. Timepoint: in the begining and after 3 month. Method of measurement: ELISA.;PYY. Timepoint: in the begining and after 3 month. Method of measurement: ELISA.;GLP-1. Timepoint: in the begining and after 3 month. Method of measurement: ELISA.;Weight. Timepoint: in the begining, after 1 month, after 2 month and after 3 month. Method of measurement: scale.

Secondary

MeasureTime frame
Macronutrients intake. Timepoint: in the begining, after 1 month, after 2 months and after 3 months. Method of measurement: food recall questionnaire.;Cholesterol. Timepoint: in the begining and after 3 months. Method of measurement: enzymatic method.;Energy intake. Timepoint: in the begining, after 1 month, after 2 months and after 3 months. Method of measurement: food recall questionnaire.;LDL. Timepoint: in the begining and after 3 months. Method of measurement: Friedwald.;Physical activity. Timepoint: in the begining and after 3 months. Method of measurement: physical activity questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSamira Rabiei

Faculty of Nutrition and Food Sciences

samirarabiei@yahoo.com+98 21 2236 0657

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026