Metabolic Syndrome
Conditions
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.
Interventions
DIETARY_SUPPLEMENTSynbiotic
DIETARY_SUPPLEMENTPlacebo
Sponsors
National Nutrition and Food Technology Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HOMA-IR | 28 weeks |
Outcome results
None listed