Clinical validation of NRL/2019/NMP with micronutrient fortification to assess the efficacy and safety in promoting health and well-being in healthy adults-Randomized controlled trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Anthropometric analysis
研究概览
简要总结
By taking in to consideration the need of good protein supplementfor both male and female, the netsurf communication has designed and developedthe NRL/2019/NMP protein supplement with micronutrient fortification for bothmale and female to help to manage health and quality of life. The current research is undertaken to assess the efficacy andsafety of the NRL/2019/NMP with micronutrient fortification to promote healthand wellbeing in healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group 18 years to 65 years BMI in the range of 20 to 26 Subjects in good physical condition and sound mental status In the judgment of the Principal Investigator able to comply with protocol requirements Subjects willing to sign written informed consent Willingness to abstain from use of vitamin or mineral supplements, nutritional supplements and or medical foods if applicable.
排除标准
- •Allergies to ingredients in product/ milk Subjects with uncontrolled and uncomplicated diabetes (HbA1C NMT 7.0 percentage and blood pressure NMT 140/90 mm hg) may or may not be on prescription.
- •Subjects with past history of addiction abuse and rehabilitation Subject more than 2 events of alcohol consumption per week Subjects with current medical history of any major illness such as cancer, heart disease, COPD ,Asthma etc.
- •in the past Subjects with history of any acute or chronic illness that may affect the patient’s participation in the study Use of prescription medications and/or nonprescription medications for weight loss.
- •Subjects with acute illness or history of major or minor surgery in the past one year Female subjects who are currently pregnant and/or breast feeding Subjects not willing to participate in study.
结局指标
主要结局
Anthropometric analysis
时间窗: Baseline, day 30, 60 and 90.
Daily energy questionnaire Endurance levels by VO2 max Perceived stress levels
时间窗: Baseline, day 30, 60 and 90.
Immunity via number of events of recurrent UTI/RTI etc.
时间窗: Baseline, day 30, 60 and 90.
Regulation of lipid levels
时间窗: Baseline, day 30, 60 and 90.
HbA1c and glycemic profile ie blood sugar levels
时间窗: Baseline, day 30, 60 and 90.
次要结局
- Quality of life (Physical, mental and social) General Health Questionnaire-28 (GHQ-28)(Changes in digestive behavior assessment)