Clinical trial of NRL/2019/NMP in promoting health and well-being in healthy adults

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.

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/06/025696

Enrollment

100

Registered

2020-06-08

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: NRL/2019/NMP: 10 gm protein supplement with 150 ml milk Control Intervention1: Marketed product: 10 gm Protein supplement with 150 ml milk

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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 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

Design outcomes

Primary

Measure	Time frame
Daily energy questionnaire Endurance levels by VO2 max Perceived stress levels Immunity via number of events of recurrent UTI/RTI etc. Anthropometric analysis HbA1c and glycemic profile ie blood sugar levels Regulation of lipid levelsTimepoint: Baseline, day 30, 60 and 90.	—

Secondary

Measure	Time frame
Quality of life (Physical, mental and social) General Health Questionnaire-28 (GHQ-28) Changes in digestive behavior assessment Changes in mood behavior Safety profiling by LFT, RFT and thyroid profile etc. Assessment of Overall Improvement by subject and investigator Adverse events Changes in sleep quality questionnaire Palatability with dosage compliance of test productTimepoint: Baseline, day 30, 60 and 90.	—

Measure

Time frame

Quality of life (Physical, mental and social) General Health Questionnaire-28 (GHQ-28) Changes in digestive behavior assessment Changes in mood behavior Safety profiling by LFT, RFT and thyroid profile etc. Assessment of Overall Improvement by subject and investigator Adverse events Changes in sleep quality questionnaire Palatability with dosage compliance of test productTimepoint: Baseline, day 30, 60 and 90.

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Countries

India

Contacts

Public ContactOmkar Kulkarni

Netsurf Research Labs Pvt Ltd

omkar.kulkarni@nrl.net.in09922435119

Outcome results