To evaluate the efficacy and safety of Weight Management Program in Overweight/Obese Individuals: A 4 Arm open label randomized controlled clinical study
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- To evaluate number & percentage of subjects demonstrating reduction in BMI/ weight between inter & intra arms from baseline to the end of the maintenance phase.
研究概览
简要总结
Overweight and obesity are defined as abnormal or excessive fat accumulation that may impair health. This illness is a global pandemic with a high prevalence in western societies but also fast spreading across developing countries. According to one study, it is predicted that the prevalence of overweight will be more than double among Indian adults aged 20–69 years between 2010 and 2040, while the prevalence of obesity will triple. It is a major risk factor for several lifestyle conditions such as metabolic syndrome, Diabetes, hypertension, CVDs, atherosclerosis and sleep disorders. A wide variety of obesity management strategies are presently practiced including lifestyle changes in terms of diet and physical activity; behavioral treatment strategies to improve adherence to lifestyle interventions; pharmacological and herbal dietary products-based strategies and bariatric surgery for treating extreme cases. The science and philosophy behind a healthy weight management program is to provide a multifaceted support focusing on lifestyle modification with inclusion of the essential components of nutrition, physical activity and even product interventions as weight control measures. Many studies have demonstrated the use of meal replacements as an effective and proven solution in structured weight loss. Similarly, amount and timing of consumption of nutrients like protein and fiber has also been an established evidence in successful weight loss strategies. To add on to the benefit, the gut reset component has been a crucial aspect as well. Trillions of bacteria residing in intestine are known as gut microbiome. These microbes digest the complex carbohydrates and release short chain fatty acids which are known to play crucial role in various metabolic functions including glucose metabolism. Imbalanced diet, sedentary lifestyle, lack of sleep, antibiotics can cause an imbalance in the gut microbial ecosystem. This, in turn, is closely associated with weight gain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female subjects age between 20 to 45 years Non-pregnant and non-lactating BMI (kg/m2)- ≥ 23 (considered overweight/obese as per the ethnicity cut off values for Asian Indians) Following stable eating habits Not on any medication that can affect Lipid profile, body composition or weight Nonalcoholic and non- smoker Subjects who are willing to sign the informed consent and comply with study requirement of meal replacements strictly.
- •Women in the reproductive age group- should be agreeing to follow standard contraceptive measures Individuals who are seriously motivated to lose weight and willing to be part of any one of the interventions where Protein drink with buttermilk, skimmed milk or water OR 1 Meal replacement OR 2 Meal replacement would be given.
排除标准
- •On medication/ HRT (Hormone Replacement Therapy) -Suffering from endocrine hypothalamic- pituitary disease, women with PCOS, adrenal disorder, hypothyroidism, -Subjects with Diabetes type 1 or 2 to be excluded -Women in the reproductive age group not willing to use standard contraceptive measures.
- •Other conditions like CKD, stones, liver dysfunction (with elevated enzyme levels), history of cancer, eating disorders, chronic gastrointestinal disorders (IBD or celiac), metabolic disorders like hypertension, CVDs- that might impair the outcomes -Malignancy which is currently active or in remission for less than five years after last treatment -Unstable weight (± 5 % fluctuation in their body weight for past 8-weeks at study entry) -Have undergone gastroplasty or weight reducing surgery -Subjects who have participated in another clinical study within the past 30 days prior to screening or are likely to simultaneously participate in another clinical study.
- •Practicing any structured commercial weight management program/ intermittent fasting or any diet regime in the last 30 days prior to screening.
- •Patients who are doubtful to comply with study procedures for mental, psychological or social reasons.
结局指标
主要结局
To evaluate number & percentage of subjects demonstrating reduction in BMI/ weight between inter & intra arms from baseline to the end of the maintenance phase.
时间窗: Intensive phase (Day 1 to Day 30) | During the intensive phase, all the intervention arms will be followed up on daily basis with | -Daily Telephonic calls | -Weekly once on-site visit | Maintenance Phase (Day 31 to Day 60) | During the maintenance phase, all the intervention arms will be followed up on weekly basis with | -Weekly Telephonic call & | -Biweekly once on-site visit
Gut reset (-10 to Day 0) phase (except control arm): Will precede intensive and maintenance phase.
时间窗: Intensive phase (Day 1 to Day 30) | During the intensive phase, all the intervention arms will be followed up on daily basis with | -Daily Telephonic calls | -Weekly once on-site visit | Maintenance Phase (Day 31 to Day 60) | During the maintenance phase, all the intervention arms will be followed up on weekly basis with | -Weekly Telephonic call & | -Biweekly once on-site visit
To evaluate the number & percentage of subjects demonstrating reduction in BMI/ weight between inter & intra arms from baseline to the end of the intensive phase.
时间窗: Intensive phase (Day 1 to Day 30) | During the intensive phase, all the intervention arms will be followed up on daily basis with | -Daily Telephonic calls | -Weekly once on-site visit | Maintenance Phase (Day 31 to Day 60) | During the maintenance phase, all the intervention arms will be followed up on weekly basis with | -Weekly Telephonic call & | -Biweekly once on-site visit
次要结局
- To assess the number of subjects between inter and intra arms maintaining the lost weight after intensive phase.(Day 31 to Day 60)
- To evaluate the reduction in skinfold thickness and WHR among subjects between inter and intra arms(Day 1 and Day 90)
- To evaluate the changes in Body fat percentage among subjects between inter and intra arms(Day 1 and Day 90)
- To assess the number and percentage of subjects demonstrating improvement in lipid profile between inter and intra arms(Day 1 and Day 90)
- To assess the number and percentage of subjects demonstrating improvement in parameters assessed by Body composition analyzer(Day 1, Day 7, Day 15, Day 22, Day 30, Day 45, Day 60, Day 75 and Day90)
- Changes in the quality of life using WHOQOL- BREF between inter and intra arms(Day 1 and Day 90)
- Incidence of any adverse events during study in each arm(Day 1 and Day 90)
- Compliance to the study(Day 7, 15, 22, 30, 37, 45,52, 60, 67, 75 and Day 82)
- Changes in the clinical parameters between inter and intra arms(Day 1 and Day 90)