An Open Label, Prospective, Non-Randomised, Non-Comparative, Single Arm Clinical Study to Evaluate the Effectiveness, Safety and Tolerability of “Minvitein†of Essen Fooddies India Pvt. Ltd. as a Nutritional Supplement in Adult Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1. Strength : Stair Climbing : Increase of 20% from baseline
研究概览
简要总结
Study Design : Open Label, Prospective, Non-Randomised, Non-Comparative, Single Arm Clinical Study
Indication : Nutritional Supplement for Clinically Healthy Adults
Investigational Product Details Name : Minvitein Route of Administration : Oral Formulation : Powered Nutritional Formulation Dose : 50g (5 scoops) in 150ml lukewarm water Dosage : OD for 3 months
Subject Population : Clinically healthy adult subjects between the ages of 18 and 65 years (both ages and all genders inclusive)
Treatment Arms : One. Non Comparative Single Arm Study
Number of Subjects : 50 Subjects
Efficacy Assessments: 1. Strength : Stair Climbing : Day 1, Day 45, Day 90 2. Controls Hunger : Daily EATS Questionnaire : Day 1, Day 45, Day 90 3. Satiety : Daily EATS Questionnaire : Day 1, Day 45, Day 90 4. Patient’s Global Impression Scale : Day 90
Safety Assessments: 1. Clinical Safety : CBC, Serum Biochemistry 2. Monitoring of Adverse Events
Background of the study: A nutritional state resulting from an inadequate intake ofnutrients, particularly in energy (though also protein and micronutrients), leadsto reduced mass, reduced requirement, reduced work, physiologic and metabolicchanges, changes in body composition, and loss of tissue reserve. Oral nutritionalsupplements can be prescribed to supply one or more nutrient deï¬ciencies andrestore the proper development and function of the body. The aim of suchproducts is to supplement everyday diet with nutrients in an effort to elevatethe health status in adults.
Purpose of the Study : Minvitein is a nutritional supplement designed by Essen Fooddies India Pvt. Ltd with key ingredients that have been researched in improving general health in clinically healthy adults. This clinical study is designed as an open label, prospective, non-randomised, non- comparative, single arm clinical study to evaluate the efficacy, safety and tolerability of “Minvitein†as a nutritional supplement for clinically healthy adults.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Clinically healthy adult subjects between the ages of 18 and 65 years (both ages and all genders inclusive).
- •2.Subjects who are willing to abstain from use of herbal, allopathic or other nutritional supplements that are indicated at improving general health.
- •3.Subjects who are not on rapid weight loss programs such as but not limited to keto, paleo, warrior, caveman diets.
- •Intermittent fasting is permitted.
- •5.Subjects who are willing to give informed consent for participation, able to comprehend and understand the responsibilities during screening and treatment period.
- •6.Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
排除标准
- •1.Subjects with known hypersensitivity to the ingredients of the investigational product.
- •2.Subjects who are diagnosed with Galactosemia.
- •3.Subjects who have an active infection, disease or disorder that will prevent them from fully satisfying the responsibilities of the study.
- •4.Subjects with history of seizures, uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc.
- •5.Subjects on remission from cancer of any type less than 5 years at the time of screening.
- •6.Subjects who are planning a pregnancy and/or currently breastfeeding.
- •7.Subjects who have participated in a clinical study less than 1 month before screening.
- •8.Any significant medical condition (e.g., significant psychiatric or neurological disorders , active alcohol/drug abuse, etc.), any medical condition that is unstable/poorly controlled or other factor (e.g., planned relocation) that the Investigator felt would interfere with study evaluations and study participation.
- •9.Subjects who are mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
- •10.Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.
结局指标
主要结局
1. Strength : Stair Climbing : Increase of 20% from baseline
时间窗: 1. Strength : Stair Climbing : Day 1, Day 45, Day 90 | 2. Controls Hunger : Daily EATS Questionnaire : Day 1, Day 45, Day 90 | 3. Satiety : Daily EATS Questionnaire : Day 1, Day 45, Day 90 | 4. Patient’s Global Impression Scale : Day 90
2. Controls Hunger : Daily EATS Questionnaire : Decrease of 10 total score
时间窗: 1. Strength : Stair Climbing : Day 1, Day 45, Day 90 | 2. Controls Hunger : Daily EATS Questionnaire : Day 1, Day 45, Day 90 | 3. Satiety : Daily EATS Questionnaire : Day 1, Day 45, Day 90 | 4. Patient’s Global Impression Scale : Day 90
4. Patient’s Global Impression Scale : Score of 4 at end of study.
时间窗: 1. Strength : Stair Climbing : Day 1, Day 45, Day 90 | 2. Controls Hunger : Daily EATS Questionnaire : Day 1, Day 45, Day 90 | 3. Satiety : Daily EATS Questionnaire : Day 1, Day 45, Day 90 | 4. Patient’s Global Impression Scale : Day 90
3. Satiety : Daily EATS Questionnaire : Increase of 2 scores from baseline
时间窗: 1. Strength : Stair Climbing : Day 1, Day 45, Day 90 | 2. Controls Hunger : Daily EATS Questionnaire : Day 1, Day 45, Day 90 | 3. Satiety : Daily EATS Questionnaire : Day 1, Day 45, Day 90 | 4. Patient’s Global Impression Scale : Day 90
次要结局
未报告次要终点