Effect of NRL/2019/5PNW to promote health and well being in woman in fertile age

Phase 2

Recruitment & Eligibility

Inclusion Criteria

Fertile Women Aged 18 - 50 years

BMI in the range of 20-26 Kg/m2 should be incorporated

Subjects having 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

Willing to abstain from use of additional 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.

Presence of any major illness such as cancer, heart disease, COPD, Asthma etc.

Subjects with 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.

Subjects with history of hysterectomy, IUI and IVF

Subjects with PCOS and or on any hormone replacement therapy

Subjects on oral hormonal contraceptive

Primary Outcome Measures

Name	Time	Method
Changes in Daily energy levels <br/ ><br>Changes in Menstrual regulation <br/ ><br>Changes in biochemical parameters like-Serum Iron, Serum Calcium, Ferritin, TIBC <br/ ><br>Changes in Immunity assessed by number of events of recurrent UTI/RTI <br/ ><br>Changes in hormonal profile- FSH, LH, Prolactin, Testosterone, Serum Insulin <br/ ><br>Change in Anthropometric parameters <br/ ><br>Change in HbA1c and glycaemic profile (blood sugar levels)Timepoint: from baseline to end of study

Secondary Outcome Measures

Name	Time	Method
Change in Quality of life (Physical, mental and social) General Health Questionnaire-28 (GHQ-28) <br/ ><br>Changes in mood behavior <br/ ><br>Sleep quality questionnaire <br/ ><br>Perceived stress questionnaire <br/ ><br>Safety profiling by LFT, RFT, TFT and lipid profile <br/ ><br>Assessment of Overall Improvement by subject and investigator <br/ ><br>Palatability with dosage compliance of test product <br/ ><br>Percentage of participants with adverse events <br/ ><br>Changes in the vitals <br/ ><br>Tolerability of study supplements <br/ ><br>Changes in laboratory parametersTimepoint: from baseline to end of study