| CTRI Number |
CTRI/2012/08/002856 [Registered on: 03/08/2012] Trial Registered Retrospectively |
| Last Modified On: |
03/04/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of probiotic and omega-3 fatty acid on blood glucose and lipid levels and gut bacteria in overweight/ obese volunteers |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIN-OBESITY-VSL#3 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R Hemalatha |
| Designation |
Deputy Director/Scientist E |
| Affiliation |
National Institute of Nutrition |
| Address |
National Institute of Nutrition
Tarnaka
Jamai-Osmania,
Hyderabad
Hyderabad
ANDHRA PRADESH
500 007
India |
| Phone |
040-27197297 |
| Fax |
040-27019074 |
| Email |
rhemalathanin@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Hemalatha |
| Designation |
Deputy Director/Scientist E |
| Affiliation |
National Institute of Nutrition |
| Address |
National Institute of Nutrition
Tarnaka
Jamai-Osmania,
Hyderabad
Hyderabad
ANDHRA PRADESH
500 007
India |
| Phone |
040-27197297 |
| Fax |
040-27019074 |
| Email |
rhemalathanin@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Hemalatha |
| Designation |
Deputy Director/Scientist E |
| Affiliation |
National Institute of Nutrition |
| Address |
National Institute of Nutrition
Tarnaka
Jamai-Osmania,
Hyderabad
Hyderabad
ANDHRA PRADESH
500 007
India |
| Phone |
040-27197297 |
| Fax |
040-27019074 |
| Email |
rhemalathanin@yahoo.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Nutrition, Hyderabad |
|
|
Primary Sponsor
|
| Name |
National Institute of Nutrition |
| Address |
National Institute of Nutrition
Jamai-Osmania PO
Hyderabad-500 007,
Andhra Pradesh
India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr R Hemalatha |
Dept. of Microbiology and Immunology, Clinical Division, National Institute of Nutrition |
National Institute of Nutrition (Indian Council of Medical Research)
Tarnaka
Hyderabad-500-007
Hyderabad
ANDHRA PRADESH |
040-27197297
040-27019074
rhemalathanin@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee- National Institute of Nutrition |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Overweight/Obese, Non-diabetic, non-hypertensive,without any Gastrointestinal disorders |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Omega-3 fatty acids capsules |
2 caps daily for 6 weeks; oral; Each capsule contains 180mg of EPA(Eicosapentaenoic acid)and 120mg of DHA (Docosahexaenoic acid) |
| Comparator Agent |
Placebo capsules |
1 cap daily for 6 weeks; oral; Capsule contains microcrystalline cellulose |
| Intervention |
VSL#3 Capsules |
1 cap daily for 6 weeks; 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 infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei, and Lactobacillus delbrueckii subsp. bulgaricus |
| Intervention |
VSl#3 Capsules + Omega-3- fatty acids capsules |
VSL#3 caps: 1 cap daily for 6 weeks; oral;
Omega-3-fatty acids capsules: 2 caps daily for 6 weeks; oral |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age: 40-60 Yrs; Both male and female; Overweight subjects (BMI > 25) etc. |
|
| ExclusionCriteria |
| Details |
Hypertension; Diabetes Mellitus; Any metabolic disorder; GI disorders; Alcohol consumption; Smoking; antibiotic therapy etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the effect of VSL#3 and omega-3 fatty acids on inflammatory markers, lipid profile characteristics, insulin sensitivity and gut flora. |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
06/08/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized, open-labeled, 4-arm arm trial to study the effects of supplementation with a probiotic preparation, VSL#3 and/or omega-3-fatty acids in healthy obese volunteers to look out for changes in serum inflammatory markers (TNF-alpha, IL-6, CRP, IL-1 Beta), lipid profile (Total cholesterol, HDl, LDL, VLDL, triglycerides), insulin sensitivity (Insulin resistance by HOMA-IR) and gut flora (fecal samples processed for quantification of bacterial strains by RT-PCR). The study Period is for 6 months from the recruitments and additional 2 months for data management and analysis. The volunteers would be screened and the study population will comprise of 60 cases. They would be randomized to 4 arms, namely, placebo, VSL#3, omega-3-fatty acids and VSL#3 + omega-3-fatty acids and provided with drugs for 6 weeks. Baseline characteristics and study related parameters would be assessed at baseline and after treatment of 45 days.
Specific probiotic strains improve intestinal barrier function, and may potentially diminish the translocation of micro-organisms and their derivatives, for example, lipopolysaccharide (LPS), from the gut to the systemic circulation, thereby reducing the concomitant release of pro-inflammatory cytokines via Toll-like receptor (TLR)-4 signalling. VSL#3 – a probiotic preparation contains 8 different strains of bacteria will be investigated to test its effects on insulin resistance, lipid profile, inflammation and gut microflora. Synergistic effect of VSL#3 and omega-3 fatty acid, a known anti-inflammatory nutrient, will also be investigated. Thus a study will be undertaken with the following objectives.
-
To evaluate the effect of VSL#3 on insulin sensitivity and inflammation in overweight and obese subjects.
-
To evaluate the synergistic impact of VSL#3 and omega-3 fatty acid on insulin sensitivity and inflammation in overweight and obese subjects.
-
To determine the effect of VSL#3 on gut bacteria modulation and colonization ability of specific strains of VSL# 3. |