A randomized, parallel, two-arm clinical trial to evaluate the efficacy and safety of a Meal Replacement regime for weight reduction and maintenance in Obese adults.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 217
- 试验地点
- 2
研究概览
简要总结
The present research is a holistic treatment measure aimed at both the acute weight loss and weight maintenance in the long-term by a well-constructed two-stage treatment program.
The justification of this study is founded on a number of major considerations:
• Phase I - Weight Reduction Phase: The first three months phase aims at realizing clinically significant weight loss by the use of a structured meal replacement program with SlimSEB supplementation and nutritional counseling. This method will satisfy the urgent demand to have effective weight loss but will also provide the behavioral patterns that will prove to be sustainable. The meal replacement method is backed up by massive evidence that depicts that it is more effective in contrast to traditional dietary methods.
• Phase II - Weight Maintenance Phase: The next three-month maintenance period is directly aimed at overcoming the problem of weight loss maintenance by the further SlimSEB supplementation and lifestyle support. This step fills the very important gap in obesity treatment, in which majority of interventions do not perfectly support weight maintenance in the long-run.
• Comprehensive Outcome Assessment: The study protocol will involve the use of several assessment instruments that have been proven to measure the entire range of intervention outcomes such as anthropometric measurements, metabolic parameters, body composition analysis, and quality of life indicators. It is a holistic method that allows assessing the effectiveness and safety of interventions and gives some understanding of how effective weight control works.
• Multi-center Design and Clinical Relevance: The multi-center design increases the extrapolation of the results and facilitates the application of the research results into clinical practice. The research aims to focus on people who are already obese with Class II (BMI 35-45 kg/m 2), a group of people who are already at high risk of obesity related comorbidities and would greatly need effective weight management interventions.
The two-phase design of the study deals with the acute problem of meaningful weight loss and the chronic problem of the maintenance of weight loss with time. The proposed study will advance the study of meal replacement techniques as well as the introduction of new supplementation interventions and support systems to help patients with weight-related health problems and healthcare providers in managing obesity. The strong emphasis on safety tracking, outcome measures, and length-of-follow follow-up qualifies this study to be of great importance in our knowledge of effective weight management strategies and its application in clinical practices. The results of this study could be used in clinical practice, regulatory practices, and eventually lead to the betterment of the lives of obese people in the global community.
This study comprises of two parts
- Study 1A
- Study 1B
Blinding
- Study 1A - This part is open-labelled.
- Study 1B - This part is double blinded.
Sample Size
- Study 1A - Total 130 subjects.
- Study 1B - Total 87 subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Self reported healthy adults between 18 to 65 years
- •Individuals with a BMI ranging from 35 to 45 kg/m2, inclusive
- •Able to give free, informed and express consent to participate
- •Individuals seeking to consult a nutritionist for personalized weight-loss diet plan
- •Participants should be in overall good physical and mental health, not regularly using any medications or dietary supplements, and must be willing to discontinue probiotic supplements probiotic enriched products and fibre supplements if applicable for at least the last 2 months prior to enrolment.
- •They should also commit to maintaining a consistent dietary pattern throughout the study period.
- •Individuals judged appropriate for the study by the attending physician.
- •Willingness to complete all study visits, assessment questionnaires, and diaries.
- •Eligible individuals from study 1A who have lost greater than or equal to 5% of their body weight in last 3 months due to IP
- •Willing to sign ICF.
排除标准
- •Diagnosed with a general physical or mental health problem e.g. peptic ulcer, inflammatory bowel disease, depression, anxiety, insomnia, acute metabolic complications, endocrine diseases, hypoglycaemia, etc.
- •or systemic disease that may pose a safety risk, interfere with the dietary intake of the investigational product, or impact the assessment of study outcomes.
- •Cardiovascular diseases or medical conditions unsuitable for exercise, hypertension, metabolic disorders or concurrent dietary supplement use.
- •Taking weight or appetite affecting medications or drugs like selective serotonin reuptake inhibitors SSRIs, GLP-1 receptor agonists and steroids and gastrointestinal motility-affecting medications.
- •Liver function damage, Urinary or reproductive system infection, renal dysfunction.
- •Individuals likely to develop an allergy to the test substance like milk products and lactose intolerant.
- •Participants must not be currently enrolled in another clinical trial or planning to enroll in one during the study period and must comply with the required exclusion period following participation in any prior study.
- •Chronic alcohol/drugs/tobacco dependency/addicted.
- •Pregnant women, women desiring to become pregnant, or lactating women.
- •History of any surgery in the past 3 months.
- •Individuals judged inappropriate for the study by the attending physician Study 1B
- •Participants with side effect to the IP.
研究者
Dr Dayanand Balappa Yaligar
Sri Laxmi Hospital