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
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Change in Body Weight
研究概览
简要总结
This is an open-label, four-arm, randomized, controlled clinical study designed to evaluate the efficacy and safety of a structured Weight Management Program (WMP) in overweight and obese adults with a body mass index (BMI) ≥ 23 kg/m² (Asian Indian ethnicity cut-off). A total of 140 subjects will be enrolled and randomized equally into four arms: one control arm and three intervention arms with varying levels of nutritional intervention.
The Weight Management Program comprises three sequential phases: a pre-engagement gut-reset phase (10 days), an intensive intervention phase (30 days), and a maintenance phase (60 days). The intervention arms will receive combinations of meal replacements, protein supplements, fiber supplements, probiotics, and multivitamin-multimineral supplements, along with nutritional and behavioral counseling, calorie-deficit diet plans, and prescribed physical activity. The control arm will follow a free-living lifestyle without intervention.
The primary efficacy outcome is the proportion of subjects demonstrating a reduction in body weight and/or BMI from baseline to the end of the intensive phase. Secondary outcomes include changes in body weight and BMI at the end of the maintenance phase, maintenance of weight loss, changes in body composition, waist circumference, waist-hip ratio, lipid profile, metabolic parameters, physical activity, quality of life, and safety outcomes including adverse events.
The study aims to generate evidence on the effectiveness and safety of a holistic, lifestyle-based weight management program incorporating nutritional supplementation, dietary modification, physical activity, and behavioral support in overweight and obese individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Male and female subjects age between 20 to 45 years
- •Non-pregnant and non-lactating
- •Body Mass Index (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.
研究组 & 干预措施
Arm I (Control group)
Arm II (PRP-02 before all the meals)
干预措施: Arm II (Dietary Supplement)
Arm III (1 meal replacement)
干预措施: Arm III (Dietary Supplement)
Arm IV (2 Meal replacement)
干预措施: Arm IV (Dietary Supplement)
结局指标
主要结局
Change in Body Weight
时间窗: Baseline (Day 1) to end of intensive phase (Day 30)
To assess the number and percentage of subjects demonstrating a reduction in body weight from baseline to the end of the intensive phase across intervention and control arms.
次要结局
- Change in Body Fat Percentage(Baseline (Day 1) to end of study (Day 90))
- Change in Waist Circumference(Baseline (Day 1) to end of study (Day 90))
- Change in Total Cholesterol(Baseline (Day 1) to end of study (Day 90))
- Incidence of Adverse Events(From baseline (Day 1) to end of study (Day 90))
- Change in Muscle Mass(Baseline (Day 1) to End of Study (Day 90))
- Change in Fat-Free Mass(Baseline (Day 1) to End of Study (Day 90))
- Change in Visceral Fat Level(Baseline (Day 1) to End of Study (Day 90))
- Change in Waist-to-Hip Ratio(Baseline (Day 1) to End of Study (Day 90))
- Change in Skinfold Thickness(Baseline (Day 1) to End of Study (Day 90))
- Change in Triglycerides(Baseline (Day 1) to End of Study (Day 90))
- Change in High-Density Lipoprotein (HDL) Cholesterol(Baseline (Day 1) to End of Study (Day 90))
- Change in Low-Density Lipoprotein (LDL) Cholesterol(Baseline (Day 1) to End of Study (Day 90))
- Change in Fasting Blood Glucose(Baseline (Day 1) to End of Study (Day 90))
- Change in Glycated Hemoglobin (HbA1c)(Baseline (Day 1) to End of Study (Day 90))
- Change in Serum Insulin(Baseline (Day 1) to End of Study (Day 90))
- Change in Quality of Life(Baseline (Day 1) to end of study (Day 90))
- Change in BMI During Maintenance Phase(Baseline (Day 1) to end of study (Day 90))