Effects of Synbiotic Supplementation in Metabolic Syndrome

National Nutrition and Food Technology Institute

Status and phase: Completed; Phase 3; Phase 2

Conditions: Metabolic Syndrome

Treatments: Dietary Supplement: Synbiotic; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02008838

450

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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38 participants in 2 patient groups, including a placebo group

Synbiotic

Active Comparator group

Description:

Each synbiotic capsule (Protexin, UK) contained 2 × 108 CFU of seven strains of friendly bacteria (Lactobacillus casei, Lactobacillus rhamnosus, Streptococcus thermophilus, Bifidobacterium breve, Lactobacillus acidophilus, Bifidobacterium longum, Lactobacillus bulgaricus), prebiotics (FOS \[Fructooligosaccharide\]), and probiotics culture (Magnesium stearate \[source: mineral and vegetable\], and vegetable capsule \[hydroxypropyl methyl cellulose\])

Treatment:

Dietary Supplement: Synbiotic

Placebo

Placebo Comparator group

Description:

250 mg Maltodexterin

Treatment:

Dietary Supplement: Placebo