Clinical validation of NRL/2019/NMP with micronutrient fortification to assess the efficacy and safety in promoting health and wellbeing in healthy adults - Randomized placebo controlled trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Changes mean in total General Health Questionnaire-28 (GHQ-28) score.
研究概览
简要总结
The purpose of the research is evaluating safety and efficacy of protein supplement NRL/2019/NMP for improving health and wellbeing in healthy individuals. The product is composed of plant based proteins, micronutrients like vitamins, minerals and probiotics like Bifidobacterium, Lactobacillus together with some specialized natural ingredients like Colostrum, Omega 3 DHA, Aloe Vera and Zeaxanthin etc. By virtue of the selection of the ingredients, NRL/2019/NMP may provide health benefits to improve quality of life, energy, endurance and digestive behavior.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 25.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age group: 25-45 years 2.BMI in the range of 20-26 3.Subjects in good physical condition and sound mental status.
- •4.In the judgment of the Principal Investigator, able to comply with protocol requirements.
- •5.Subjects willing to sign written informed consent 6.Willingness to abstain from use of vitamin or mineral supplements, nutritional supplements and or medical foods if applicable.
排除标准
- •1.Allergies to ingredients in product/ milk 2.Subjects with uncontrolled and complicated diabetes (HbA1C NMT 5.7% and blood pressure NMT 140/90 mm hg) may or may not be on prescription.
- •3.Subjects with past history of addiction abuse and rehabilitation 4.Subject more than 2 events of alcohol consumption per week 5.Subjects with current medical history of any major illness such as cancer, heart disease, COPD , Asthma etc.
- •in the past 6.Subjects with history of any acute or chronic illness that may affect the patient’s participation in the study 7.Use of prescription medications and/or nonprescription medications for weight loss.
- •8.Subjects with acute illness or history of major or minor surgery in the past one year.
- •9.Female subjects who are currently pregnant and/or breast feeding 10.Subjects not willing to participate in study 11.Subjects with deranged LFT and KFT as per investigator discretion.
结局指标
主要结局
Changes mean in total General Health Questionnaire-28 (GHQ-28) score.
时间窗: Screening Baseline Day 30 Day 60 Day 90
Changes in mean serum total protein, and albumin to globulin ratio.
时间窗: Screening Baseline Day 30 Day 60 Day 90
Changes in mean BMI, fat %, skeletal muscle %, through impedance studies for body composition along with waist and hip circumferences.
时间窗: Screening Baseline Day 30 Day 60 Day 90
Changes in mean calculated VO2 max by 6-minute walk test.
时间窗: Screening Baseline Day 30 Day 60 Day 90
次要结局
- Changes in % responders (subjects showing reduction of 25% of low energy scores in 30 days’ time) on daily energy questionnaire.(Changes in mean total digestive behavior score.)