| CTRI Number |
CTRI/2024/04/065821 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
16/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of nutritional supplement in obesity |
|
Scientific Title of Study
|
Evaluating the Efficacy and Safety of Probiotic and Fiber Supplementation in Obese
Individuals: A Randomized, Double-Blind, Placebo-Controlled, Multicentric Clinical Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/23-24/032 Version: 1.00 dated 28 Dec 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramshyam Agarwal |
| Designation |
Principal Investigator |
| Affiliation |
Lokmanya Medical Research Centre |
| Address |
Lokmanya Medical Research Centre Fourth-floor OPD 401-314 B
Telco Road Chinchwad
Pune
MAHARASHTRA
411033
India |
| Phone |
8087282022 |
| Fax |
- |
| Email |
ramshyam.research@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjana Sawant |
| Designation |
New Product Development Lead |
| Affiliation |
Seven Turns Pvt. Ltd. |
| Address |
Seven Turns Pvt Ltd - The Good Bug
204, Naman Midtown Tower A, Senapati Bapat Marg, Prabhadevi West
Mumbai
MAHARASHTRA
400013
India |
| Phone |
7506391852 |
| Fax |
- |
| Email |
sanjana@seventurns.in |
|
Details of Contact Person
Public Query
|
| Name |
Kaynat Mirajkar |
| Designation |
Lead Nutritionist |
| Affiliation |
Seven Turns Pvt. Ltd. |
| Address |
Seven Turns Pvt Ltd - The Good Bug 204, Naman Midtown Tower A, Senapati Bapat Marg, Prabhadevi West
Mumbai
MAHARASHTRA
400013
India |
| Phone |
9699384096 |
| Fax |
- |
| Email |
kaynat@seventurns.in |
|
|
Source of Monetary or Material Support
|
| Seven Turns Pvt Ltd |
| The Good Bug
204, Naman Midtown Tower A, Senapati
Bapat Marg, Prabhadevi West, Mumbai,
Maharashtra 400013 |
|
|
Primary Sponsor
|
| Name |
Seven Turns Pvt Ltd |
| Address |
204, Naman Midtown Tower A, Senapati Bapat Marg, Prabhadevi West, Mumbai, Maharashtra 400013 |
| Type of Sponsor |
Other [Nutraceutical Marketing company ] |
|
|
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 Ramshyam Agarwal |
Lokmanya Medical Research Centre and Hospital |
Fourth-floor OPD
401-314 B Telco Road
Chinchwad
Pune
MAHARASHTRA |
8087282022
-
ramshyam.research@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Lokmanya Medical Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A: The Good Bug Metabolically Lean + The Good Bug Metabolic
Fiber Boost with nutritional counselling and tracking. |
1 sachet of The Good Bug Metabolically Lean (3g) + 1 scoop (8g)
The Good Bug Metabolic Fiber Boost both mixed in a 200ml of water for 90
days in the Evening (Between 5 to 6 pm). |
| Comparator Agent |
Group B: Placebo A + Placebo B with nutritional counselling and tracking. |
1 Placebo A sachet (3g) + 1 scoop of Placebo B (8g) both mixed
in 200ml of water for 90 days in the Evening (Between 5 to 6 pm). |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and females aged 30-45 years (both inclusive).2. Participants with BMI greater than or equal to 27.5 kg/m2, with significant weight gain (at least 10 kg) in the last three years.3. Participants with at least three of the following metabolic syndrome criteria (NCEP ATP III) – serum triglycerides greater than or equal to 150 mg/dL, HDL cholesterol: less than or equal to 40 mg/dL in men, less than or equal to 50 mg/dL in women, blood pressure: greater than or equal to 130 mmHg systolic or greater than or equal to 85 mmHg diastolic, fasting blood glucose greater than or equal to 100 mg/dL, Abdominal obesity, waist circumference: Men greater than 90 cm; Women greater than 80 cm.4. Participants with the absence of any diet or medication that might interfere with metabolic homeostasis and gut microbiota, especially oral/IV antibiotics and/or probiotics 3 months before recruitment.5. Participants providing voluntary, written informed consent to participate in the study |
|
| ExclusionCriteria |
| Details |
1. Participants with BMI values less than or equal to 27.5 and greater than or equal to 40 kg/m2
2. Participants with fasting blood glucose greater than 180 mg/dL, postprandial blood glucose greater than 250 mg/dL, triglycerides greater than 500 mg/ dL, TSH levels less than 0.5 & greater than 4.5 mIU/L and blood pressure greater than 155/100 mmHg
3. Participants with comorbidities including but not limited to Type 1 (insulin-dependent) diabetes, polycystic ovary syndrome (PCOS), vascular disease, neurological disease, chronic pain, etc.
4. Participants engaging in frequent strenuous exercise (e.g., marathon running/heavy weight lifting)
5. Participants who have undergone surgery in the last 6 months including but not limited to angioplasty, abdominal surgeries (including weight loss surgery) or partial/complete resection of stomach or bowel
6. Participants with the presence or history of psychiatric illnesses, including eating disorders
7. Participants using medications such as high doses of vitamin D, fiber supplements known to affect hunger/satiety/appetite/gut microbiome or currently using blood thinners
8. Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study
9. Participants with a history of substance abuse or heavy use of alcohol and drugs or tobacco use, where participants smoke more than 1/2 pack per day
10. Participants with a significant change in usual diet and/or weight loss of more than 4.5 kg in the last 2 months
11. Participants with chronic bowel diseases, severe immunosuppression
12. Participants enrolled in another obesity treatment program and those who, in the investigator’s opinion, are unable to complete the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Anthropometric parameters including body weight (kg), basal
metabolic rate (BMR), BMI, waist and hip circumference, along with
skeletal muscle mass and body fat percentage using bioelectric impedance analysis (BIA) |
At screening, and at day 30, 60, and end of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Biochemical parameters - HbA1c, fasting glucose, post prandial blood glucose and
lipid profile - total cholesterol, triglycerides, LDL cholesterol, and HDL cholesterol will be assessed
2. Digestive health symptoms - acidity, bloating, bowel movements,
cravings, hunger and satiety as per self-assessment questionnaire score
using a 4-point ordinal scale and 11-point numerical rating scale
3. Impact of Weight on Quality of Life-Lite (IWQOL-Lite) score
4. Perceived stress scale-10 (PSS-10) score
5. Metabolic Syndrome Severity Z Score (MetZ score)
6. Thyroid stimulating hormone (TSH) level
7. Clinical global impression–improvement scale |
1. At screening and the end of the study.
2. At screening, day 30, 60, and end of the study
3. At screening and end of the study
4. At screening, and end of the
5. At screening and end of the study (Day 90)
6. At screening and the end of the study
7. At the end of the study |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
29/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The rationale for conducting the proposed study on the efficacy and safety of probiotic and fiber supplementation in obese individuals stems from several key factors: There is growing evidence suggesting that alterations in the gut microbiota composition, known as dysbiosis, may play a role in the development and progression of obesity. Studies have identified differences in the gut microbiota between obese and lean individuals, with specific microbial profiles associated with metabolic health.
Probiotics, which are beneficial microorganisms that confer health benefits when consumed, alongside dietary fiber, known for its role in promoting gut health, have both been implicated in modulating the gut microbiota and potentially influencing metabolic outcomes. However, the specific effects of probiotic and fiber supplementation in obese individuals warrant further investigation.
While dietary interventions are a cornerstone of obesity management, achieving long-term success remains a challenge for many individuals who struggle to sustain weight loss or experience weight regain over time. Therefore, exploring adjunct therapies such as probiotic and fiber supplementation could offer additional strategies for improving weight management outcomes.
Overall, conducting a randomized, placebo-controlled clinical trial to investigate the efficacy and safety of probiotic and fiber supplementation in obese individuals addresses an important gap in the current understanding of obesity management and has the potential to provide valuable insights into optimizing treatment approaches for this prevalent and complex condition.
|