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

Randomized control trial to assess the efficacy and safety of NRL/2019/5PNV with micronutrient fortification to promote health and wellbeing in healthy adults - Nil

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/10/021716

Enrollment

100

Registered

2019-10-18

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/2019/5PNV: Protein supplement with micro nutrient fortification Control Intervention1: Marketed product: Protein supplement with micro nutrient fortification

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactDr Priya Khare

Netsurf Research Labs Pvt Ltd

omkar.kulkarni@nrl.net.in

Outcome results