Effects of Synbiotic Supplementation in Metabolic Syndrome

NCT02008838 | Completed Phase 2

• 1 other identifier: 450
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• HOMA-IR

  28 weeks

Study Arms (2)

Synbiotic

ACTIVE COMPARATOR

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 \[hydroxypropyl methyl cellulose\])

Dietary Supplement: Synbiotic

Placebo

PLACEBO COMPARATOR

250 mg Maltodexterin

Dietary Supplement: Placebo

Interventions

Synbiotic DIETARY_SUPPLEMENT

Synbiotic

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Nutrition and Food Technology Institute: lead

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Synbiotics

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Prebiotics; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Probiotics; Food and Beverages

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Prof

Study Record Dates

• First Submitted: December 8, 2013
• First Posted: December 11, 2013
• Study Start: April 1, 2012
• Primary Completion: November 1, 2012
• Last Updated: December 11, 2013

Record last verified: 2013-12