Effect of probiotic and omega-3 fatty acid on blood glucose and lipid levels and gut bacteria in overweight/ obese volunteers

A randomized controlled intervention study to determine the synergistic effect of probiotic and omega-3 fatty acid on lipid profile, insulin sensitivity, inflammatory markers and colonization ability on overweight/ obese volunteers

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/08/002856

Enrollment

Registered

2012-08-03

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Intervention: probiotics, Omega-3 fatty acid capsule Comparator: cellulose capsules: A probiotic mixture of Streptococcus thermophilus Bifidobacterium breve Bifidobacterium longum Bifi

oral

Each capsule contains 112.5 billion CFU of 8 strains of lactic acid bacteria and bifidobacteria, namely, Streptococcus thermophilus, Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium in

Each capsule contains 180mg of EPA(Eicosapentaenoic acid)and 120mg of DHA (Docosahexaenoic acid) Intervention4: VSl#3 Capsules + Omega-3- fatty acids capsules: VSL#3 caps: 1 cap daily for 6 weeks

Omega-3-fatty acids capsules: 2 caps daily for 6 weeks

oral Control Intervention1: Placebo capsules: 1 cap daily for 6 weeks

Capsule contains microcrystalline cellulose

Eligibility

Inclusion criteria

Inclusion criteria: Age: 40-60 Yrs; Both male and female; Overweight subjects (BMI > 25) etc.

Exclusion criteria

Exclusion criteria: Hypertension; Diabetes Mellitus; Any metabolic disorder; GI disorders; Alcohol consumption; Smoking; antibiotic therapy etc.

Design outcomes

Primary

Measure	Time frame
To determine the effect of VSL#3 and omega-3 fatty acids on inflammatory markers, lipid profile characteristics, insulin sensitivity and gut flora.Timepoint: 6 weeks	—

Secondary

Measure	Time frame
NoneTimepoint: None	—

Countries

India

Contacts

Public ContactDr R Hemalatha

National Institute of Nutrition

rhemalathanin@yahoo.com040-27197297

Outcome results