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

After Ethics committee’sapproval, clinical study will be registered on CTRI website. Both male andfemale subjects of age between 18 to 65 years of age (both inclusive) attendingoutpatient department of study site(s) will be screened for eligibilitycriteria. The recruitment will be done in ratio of 75:25% Male to femalerespectively.

On screening visit, awritten informed consent will be obtained from subjects for their participationin the study. Subject’s demographic details will be taken. Subject will undergoclinical examination. Subject’s medical, surgical and treatment history will betaken. Subject’s current medication if any will be noted in the case recordfrom (CRF). Subject’s vitals will be recorded. The subject will be consideredfor further evaluation as per the inclusion and exclusion criteria.

Subject’s blood sample will be collected at therespective study centers for laboratory testing i.e. CBC, ESR, Hb%, Thyroidfunction test, Liver Function Tests, Lipid Profile, Renal Function test, Randomsugar, HbA1c. Urine Routine testswill be done. During screening visit and the entire study duration subjectswill be advised to refrain from antioxidant agents, vitamins,anti-inflammatory    drugs,    hormones,   Nutraceutical,Ayurvedic,    Siddha,    Unani,  herbal /homeopathic medicines.

On baseline visit, subject will be recruited inthe study if he or she meets all the inclusion criteria. Subjects will then berandomized to one of the two study groups as per the computer generatedrandomization list. Subjects will be asked for occurrence of any adverse eventduring screening period. Subject will undergo clinical examination. Subject’svitals will be recorded. Subject’s Daily activity, Endurance levels, Perceivedstress levels and number of events of recurrent UTI/RTI etc. will be recorded.Subject’s Anthropometric analysis will be performed. Following questionnaireswill be assessed like Quality of life (Physical, mental and social) GeneralHealth Questionnaire-28 (GHQ-28), digestive behavior assessment, mood behavior,sleep quality questionnaire.

At baselinevisit and at every follow up visit (except last follow up visit), as percomputer generated randomization list, subjects will be provided withcontainers each containing 350 gms (300 gms for 30 days + additional 50 gms foruse if follow up is delayed maximum up to 5 days) of either ‘Protein Supplement’ or Standard. Subjectwill be advised to consume given supplement in a dose of 10gms in the morningwith 150 ml milk for 3 months. Subject will be advised to continue her concomitantmedication other than antioxidant agents, weight loss management, vitamins,anti-inflammatory drugs, hormones, Nutraceutical, Ayurvedic, Siddha, Unani,herbal /homeopathic medicines etc. The record of concomitant medicationwill be kept in the CRF.

Subjects will be called at respectivestudy sites for follow up visits after every month up to 3 months after thebaseline visit. On every follow up visit, Subject will undergo clinicalexamination. Subject’s vitals will be recorded. Subject’s Daily activity,Perceived stress levels and number of events of recurrent UTI/RTI etc. will berecorded. Subject’s Anthropometric analysis will be performed. Followingquestionnaires will be assessed like Quality of life (Physical, mental andsocial) General Health Questionnaire-28 (GHQ-28), digestive behaviorassessment, mood behavior, sleep quality questionnaire.

On third follow up visit (i.e. Day 90)Subject’s Daily activity, Endurance levels (steppers test), Perceived stresslevels and number of events of recurrent UTI/RTI etc. will be recorded.Subject’s blood sample will be collected at the respective study centers forlaboratory testing i.e. CBC, ESR, Hb%, Thyroid function test, Liver FunctionTests, Lipid Profile, Renal Function test, Random sugar, HbA1c. Urine Routine tests will be done.Subject’s Anthropometric analysis will be performed. Subject will be assessedfor applicable biochemical analysis and safety parameters. Followingquestionnaires will be assessed like Quality of life (Physical, mental and social)General Health Questionnaire-28 (GHQ-28), digestive behavior assessment, moodbehavior, sleep quality questionnaire. Subject’s safety biochemical parametersalong with the clinical examination will be performed. Adverse events will becritically evaluated. After completion of 3 months of study treatment, all thesubjects will be asked to stop trial medications and take advice ofinvestigator for further treatment.

Global assessment of overall improvementwill be done by subjectand investigator on last follow up visit.  Palatability with dosagecompliance will be assessed by the investigator and by subject of test productfrom baseline to end of the study.All the subjects will be closely monitored for any adverse event starting frombaseline visit till the end of the study visit.