A clinical evaluation of the safety of a Metabolically Lean Postpartum capsule for weight management in postpartum lactating women.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assessment of changes in hematological and biochemical parameters [complete blood count (CBC), liver function test (LFT), renal function test (RFT), lipid profile]
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Assessment of changes in hematological and biochemical parameters [complete blood count (CBC), liver function test (LFT), renal function test (RFT), lipid profile]
时间窗: 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.
Assessment of compliance and tolerability of the investigational product.
时间窗: 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.
Assessment of adverse events profile in mother and infant (sleep disturbances, incidences of crying, & stool pattern).
时间窗: 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.
次要结局
- 1.Assessment of changes in anthropometric parameters such as body weight (kg), and BMI(2.Assessment of changes in waist measurement (loss in inches) .)
研究者
Dr Amitkumar Patil
Sangvi Multispeciality Hospital Pvt. Ltd