A Randomized, Double-blinded, Placebo-controlled, Single-Centre, Comparative, Clinical Safety and Efficacy Study in Subjects With Overweight or Obese Class - I, to Evaluate the Degree of Significant Weight Loss by Regular Intake of Phaseolean (White Kidney Bean Standardized Extract).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change in Weight (Unit: Kg)
研究概览
简要总结
A randomized, double-blinded, placebo-controlled, single-centre, clinical safety and efficacy study in subjects with overweight or Obese Class - I, to evaluate the degree of significant weight loss by regular intake of Phaseolean (White Kidney Bean Standardized Extract).
This study is dose-response study to evaluate effectiveness of two different dosage i.e. 1500 mg Versus 3000 mg.
22 subjects will be enrolled per test treatment to complete 20 subjects per test treatment.
详细描述
A randomized, double-blinded, placebo-controlled, single-centre, clinical safety and efficacy study in subjects with overweight or Obese Class - I, to evaluate the degree of significant weight loss by regular intake of Phaseolean (White Kidney Bean Standardized Extract).
This study is dose-response study to evaluate effectiveness of two different dosage i.e. 1500 mg Versus 3000 mg.
22 subjects will be enrolled per test treatment to complete 20 subjects per test treatment.
The potential subjects will be screened as per the inclusion & exclusion criteria only after obtaining written informed consent from the subjects. The subjects will be instructed to visit the facility as per the below visits.
- Visit 01 (Within 30 Days): Screening, Baseline evaluations
- Visit 02 (Day 01): Enrolment & Treatment phase start
- Visit 03 (Day 21): Treatment Period, Evaluations
- Visit 04 (Day 45): Treatment Period, Evaluations & End of Study Visit
- Telephonic follow-up will be taken thrice a week (Monday, Wednesday and Friday) during an entire study to check compliance with the diet plan and study treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
Subjects will be randomly assigned in a 1:1:1 ratio to receive either treatment A or B or C. The randomization code will be generated by NovoBliss Research. The randomization schedule will be maintained under controlled access. Double Blind will be followed.
The Investigator/Evaluator will be blinded to the randomization schedule. The sequence number as per the randomization schedule will be used as Randomization ID.
Subjects will be randomly allocated to one of the three treatment groups, as per the randomization code. Neither the subject nor the Investigator/Evaluator shall be aware of the treatment allocation (Double Blind). To maintain blinding, the study staff who involves in treatment dispensing and distribution will not be involved in any other study-related activities.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject must fulfil all of the following inclusion criteria to be eligible for participation in the study unless otherwise specified.
- •Age: 18 to 50 years (both inclusive) at the time of consent.
- •Sex: Healthy non-pregnant/non-lactating females and Males.
- •Female of childbearing potential must have a reported negative pregnancy during screening and the end of the study.
- •Subject is generally in good health and willing to reduce weight.
- •Overweight to Obese Class - I, BMI between or equal to 25 to 35 kg/m2, or total fat percentage reaching: men > 25% and women > 30% using Karada Scan.
- •Willing to observe dietetic plan in accordance with dietitian evaluation,
- •Able and willing to participate in the study by complying with the protocol procedures.
- •Subject is willing to forgo liposuction procedures or any weight loss therapy 3 months prior to and for the duration of the study.
- •Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
- •If the female subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
- •If currently using hormonal contraception, has been using this form of contraception for at least 6 months and agrees to continue using the same contraception for the duration of the study.
- •Subject is willing to participate in exercise program (Daily, 45 mins brisk walking for consecutive 45 Days of treatment period) and recording to subject diary card.
- •Subject is willing to come in fasting state for every study visit.
- •Subject is agree to consume a vegetarian/non-vegetarian diet of approximately 2000 kcal/day (14% protein, 25%Fat and 61% carbohydrate).
- •Subject is willing to give written informed consent and are willing to follow the study procedure
排除标准
- •Subjects must not be enrolled in the study if they meet any one of the following criteria:
- •Subject has a history of allergy or sensitivity to the test treatments ingredients.
- •Subject who has a history of allergy with products containing beans, white kidney beans.
- •Subjects BMI is between less than 25 and greater than 35 kg/m
- •Subjects having past or present history or clinically significant findings indicating cardiovascular disease, type 2 diabetes mellitus, hypertension, endocrine, pulmonary, neurological or psychological disorders, hypo or hyperthyroidism and renal disorders.
- •Subjects having drug and alcohol abuse.
- •Smokers and tobacco users.
- •Subjects having more than 5 kg variation in body weight within 3 months before study entry.
- •Subjects using other weight loss medications, as well as stimulants, laxatives or diuretics taken solely for the purpose of weight loss.
- •Undergone surgery before 30 days of screening or planning to undergo surgery within the study period.
- •Subjects having chronic diarrhoeal disorders, cancer, hepatic dysfunction, and human immunodeficiency virus (HIV) infection.
- •Participation in other drugs, investigational medicinal product, any herbal products and/or cosmetics intended to weight loss clinical trials within 3 months before enrolment in this trial.
- •Any other diseases/co-morbidity that is considered by the Investigator as an exclusion.
- •With severe hepatic and/or renal impairment, liver enzyme level (ALT and/or AST) is greater than 2.5 times the upper normal limit.
- •Taking antibiotic therapy, anti-depressant treatment or treatment related to anxiety in the month preceding the study,
- •Taking anti-depressant treatment or treatment related to anxiety Subject in a state of depression.
- •Non-stable weight during the last 6 months (>5% change in total weight)
- •Consuming food supplements or functional foods known to have an influence on weight management in the month preceding the inclusion and/or likely to take during the test
- •Following or having followed a hypocaloric diet (energy intake <1,500 kCal/day) in the month preceding inclusion and/or likely to undertake this diet during the test.
- •Diagnosed eating disorders (bulimia, anorexia nervosa, vomiting),
- •Using topical anti-cellulite treatments
- •Pregnant or breastfeeding or planning to become pregnant during the study period.
- •Subject has a history of chronic illness which may influence the cutaneous state.
- •Subjects participating in other similar nutraceuticals, food, supplemental or therapeutic trials within the last four weeks.
- •Any other condition which could warrant exclusion from the study, as per the Investigator's discretion
结局指标
主要结局
Change in Weight (Unit: Kg)
时间窗: Day 1 (inclusion) to 45 Days
Mean percentage change in Body Weight in the overweight and Obese Class - I population (Males and Females) between the treatment and placebo group
Change in BMI (Unit: Kg/m2)
时间窗: Day 1 (inclusion) to 45 Days
Mean percentage change in BMI in the overweight and Obese Class - I population (Males and Females) between the treatment and placebo group
次要结局
- Change in random blood sugar(From baseline (i.e. Day 1) to Day 21, Day 45)
- Change in HbA1C(From baseline (i.e. Day 1) to Day 45)
- Change in Hip, Waist, and Thigh Circumference(From baseline (i.e. Day 1) to Day 21, Day 45)
- Change in Electrocardiogram (P wave, QRS interval, QT interval, PR interval)(From baseline (i.e. Day 1) to Day 45)
- Change in Lipoprotein lipids (HDL, LDL, Triglyceride, and Cholesterol)(From baseline (i.e. Day 1) to Day 45)
- Change in Serum Amylase(From baseline (i.e. Day 1) to Day 45)
- Change in AST and ALT levels(From baseline (i.e. Day 1) to Day 45)
- Improvement in Maximum Oxygen Consumption (VO2)(From baseline (i.e. Day 1) to Day 45)
- Percentage of subjects loosing weight(From baseline (i.e. Day 1) to Day 21, Day 45)
- Change in total Body fat(From baseline (i.e. Day 1) to Day 21, Day 45)
- Change in Serum Creatinine(From baseline (i.e. Day 1) to Day 45)
- Change in blood biochemical parameters (Serum Albumin, Total Protein, Blood Urea Nitrogen (BUN), Uric Acid, Random Insulin(From baseline (i.e. Day 1) to Day 45)
- Change in BMI(From baseline (i.e. Day 1) to Day 21, Day 45)
- Test treatment perception and consumer feedback on weight reduction, feeling of the light weight of the body, reduction of hip and waist circumference, reduction in skinfold fat thickness, hunger feeling, satiety level.(From baseline (i.e. Day 1) to Day 21, Day 45)
- Change in Heart rate(From baseline (i.e. Day 1) to Day 21, Day 45)
- Change in Blood Pressure (Both)(From baseline (i.e. Day 1) to Day 21, Day 45)
研究者
Dr Nayan Patel
Principal Investigator - Medical Director
NovoBliss Research Pvt Ltd