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NCT02008838 Clinical Trial

Effects of Synbiotic Supplementation in Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02008838
Other study ID # 450
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received December 8, 2013
Last updated December 10, 2013
Start date April 2012

Study information
Verified date December 2013
Source National Nutrition and Food Technology Institute
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Synbiotic

• Placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
National Nutrition and Food Technology Institute

Outcome
Type Measure Description Time frame Safety issue
Primary HOMA-IR 28 weeks No
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