Effect of NRL/2019/5PNV to promote health and wellbeing in healthy adults

Phase 2

Recruitment & Eligibility

Inclusion Criteria

Age group: 18 years - 65 years

BMI in the range of 20-26

Subjects will be incorporated as per 75% male and 25% female ratio

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.

Exclusion Criteria

Allergies to ingredients in product/ milk

Subjects with uncontrolled and uncomplicated diabetes (HbA1C NMT 7.0 % 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 patientâ??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

Primary Outcome Measures

Name	Time	Method
Changes in Daily activity questionnaire <br/ ><br>Changes in Endurance levels (steppers test) <br/ ><br>Changes in Perceived stress levels <br/ ><br>Changes in Immunity via number of events of recurrent UTI/RTI etc. <br/ ><br>Changes in Anthropometric analysis <br/ ><br>Changes in HbA1c and glycemic profile ie blood sugar levels <br/ ><br>Changes in Regulation of lipid levels <br/ ><br>Timepoint: From baseline to end of study

Secondary Outcome Measures

Name	Time	Method
Changes in Quality of life (Physical, mental and social) General Health Questionnaire-28 (GHQ-28) <br/ ><br>Changes in digestive behavior assessment <br/ ><br>Changes in mood behavior <br/ ><br>Changes in Safety parameters by LFT, RFT and thyroid profile etc. <br/ ><br>Changes in Assessment of Overall Improvement by subject and investigator <br/ ><br>Changes in Adverse events <br/ ><br>Changes in sleep quality questionnaire <br/ ><br>Changes in Palatability with dosage compliance of test product <br/ ><br>Timepoint: From baseline to end of study