| CTRI Number |
CTRI/2025/03/082130 [Registered on: 11/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
study of Capsule in the weight management of lactating women. |
|
Scientific Title of Study
|
A clinical evaluation of the safety of a Metabolically Lean Postpartum capsule for weight management in postpartum lactating women. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/24-25/036 Version 1.00; dated 14 Oct 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amitkumar Patil |
| Designation |
Principal Investigator |
| Affiliation |
Sangvi Multispeciality Hospital Pvt. Ltd |
| Address |
Room No (OPD) - 01 Sr no 17/1/2/189 city survey no 2387 Krushna Chowk Krushna Nagar New Sangvi
-
Pune
MAHARASHTRA
411027
India |
| Phone |
9689020590 |
| Fax |
- |
| Email |
dramitpatil.sangvihospital@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjana Sawant |
| Designation |
New Product Development Lead |
| Affiliation |
Seven Turns Pvt. Ltd. |
| Address |
The Good Bug 204 Naman Midtown Tower A Senapati Bapat Marg Prabhadevi West Mumbai
-
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 |
The Good Bug 204 Naman Midtown Tower A Senapati Bapat Marg Prabhadevi West Mumbai
-
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 Amitkumar Patil |
Sangvi Multispeciality Hospital Pvt. Ltd |
Sr no 17/1/2/189 city survey no 2387 Krushna Chowk Krushna Nagar New Sangvi
Pune
MAHARASHTRA |
9689020590
-
dramitpatil.sangvihospital@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sangvi Multispeciality Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z391||Encounter for care and examinationof lactating mother, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Metabolically Lean Postpartum capsule |
One Metabolically Lean Postpartum capsule is to be taken orally once daily after lunch with a glass of water for 90 days. |
| Comparator Agent |
Not Applicable |
NIL |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Healthy lactating females aged between 21 to 40 years both inclusive 2.Participant with a BMI between 30 to 35 kg per m² both inclusive 3.Participant with waist circumference greater than 31.5 inches or 80 cm 4.Women who are within the postpartum period specifically 16 to 20 weeks after delivering a full term infant 5.Providing voluntary written informed consent to participate in the study 6.Participants without comorbidity.
|
|
| ExclusionCriteria |
| Details |
1.Non-lactating or pregnant women
2.Women currently receiving or who have received weight loss medications or supplements within the past 3 months
3.History of or current diagnosis of type 1 diabetes mellitus (T1DM), type 2 diabetes mellitus (T2DM), and gestational diabetes mellitus (GDM), or hypothyroidism
4.Presence of significant medical conditions or contraindications that would interfere with participation in the study or affect the safety of the investigational product
5.Women who experienced significant pregnancy related complications that could impact weight or health status like severe preeclampsia major postpartum hemorrhage, hemorrhoids
6.Women who have undergone major surgery within the last 3 months except for delivery
7.Participants with heavy alcohol consumption or smoking or tobacco consumption
8.Participation in other clinical trials in the last 90 days prior to screening
9.Any condition that could in the opinion of the investigator, preclude the participants ability to complete the study or that may confound study outcomes.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of changes in hematological and biochemical parameters [complete blood count (CBC), liver function test (LFT), renal function test (RFT), lipid profile]
Assessment of compliance and tolerability of the investigational product.
Assessment of adverse events profile in mother and infant (sleep disturbances, incidences of crying, & stool pattern).
|
1.At screening, day 30, day 60, and day 90.
2.At day 30, day 60, and day 90.
3.At day 1, day 30, day 60, and day 90.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Assessment of changes in anthropometric parameters such as body weight (kg), and BMI
2.Assessment of changes in waist measurement (loss in inches) .
3.Assessment of changes in body weight and height of infant
4.Assessment of changes in the Edinburgh Postnatal Depression. Scale (EPDS) score .
5.Assessment of changes in Hamilton Anxiety Rating Scale (HAM-A) score .
6.Assessment of changes in Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) scale score |
1.At screening, day 30, day 60, and day 90.
2.At screening, day 30, day 60, and day 90.
3.At screening, day 30, day 60, and day 90.
4.At screening and day 90
5.At screening and day 90.
6.At screening and day 90.
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
24/03/2025 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Postpartum weight retention is a common concern for many women, particularly those who are lactating. Hormonal changes and the physical demands of caring for a newborn can complicate weight management during this period. Excessive weight gain can lead to long-term health issues, including obesity, diabetes, and cardiovascular diseases . Conventional dietary interventions often fall short in achieving long-term weight management, as challenges such as hormonal changes, lifestyle adjustments, and breastfeeding demands can complicate weight loss efforts. Recent studies suggest that probiotics and dietary fiber play critical roles in gut health and may support metabolic function. The Metabolically Lean Postpartum capsule aims to leverage the synergistic effects of these components to enhance weight management outcomes while ensuring safety and effectiveness for lactating women.Given that probiotics can improve gut microbiota balance and promote satiety and digestive health, this combination may address common barriers to weight loss during the postpartum period. Evaluating the safety of the Metabolically Lean Postpartum capsule is essential, as lactating women require assurance that any supplement will not adversely affect their health or milk production. |