NCT02008838
Completed
Phase 2
Effects of Synbiotic Supplementation in Metabolic Syndrome
National Nutrition and Food Technology Institute0 sites38 target enrollmentApril 2012
ConditionsMetabolic Syndrome
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Metabolic Syndrome
- Sponsor
- National Nutrition and Food Technology Institute
- Enrollment
- 38
- Primary Endpoint
- HOMA-IR
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Dr Azita Hekmatdoost
Assisstant Prof
National Nutrition and Food Technology Institute
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
Outcomes
Primary Outcomes
HOMA-IR
Time Frame: 28 weeks
Similar Trials
Not yet recruiting
Phase 3
The effect of synbiotic supplement on metabolic syndrome components in military personnel with this syndromeMetabolic syndrome.Endocrine, nutritional and metabolic diseases(E00-E90)IRCT20140502017522N3Bagheiat-allah University of Medical Sciences60
Recruiting
Not Applicable
Synbiotics Impact on Insulin and TNF-α in MAFLD: a Gut Microbiota Profile AnalysisFatty Liver DiseaseNCT06585982Universitas Diponegoro50
Recruiting
Phase 2
The effect of synbiotic supplementation on metabolic syndrome items in subjects aged 8-18 yearsIRCT20140208016529N7Esfahan University of Medical Sciences70
Completed
Phase 2
The Effects of Synbiotics Supplement on Biochemical Factors and Hepatic Fibrosis in Patients With Nonalcoholic SteatohepatitisNon Alcoholic SteatohepatitisNCT01791959National Nutrition and Food Technology Institute54
Completed
Phase 4
Synbiotic Therapy on Intestinal Microbiota and Insulin Resistance in ObesityObesityInsulin ResistanceNCT04642482Hasanuddin University16