None listed
Conditions
Interventions
Intervention1: NRL/2019/5PNW: Protein supplement with micro nutrient fortification
Control Intervention1: Marketed product: Protein supplement with micro nutrient fortification
Sponsors
Netsurf Communications Pvt Ltd
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Daily energy levels Changes in Menstrual regulation Changes in biochemical parameters like-Serum Iron, Serum Calcium, Ferritin, TIBC Changes in Immunity assessed by number of events of recurrent UTI/RTI Changes in hormonal profile- FSH, LH, Prolactin, Testosterone, Serum Insulin Change in Anthropometric parameters Change in HbA1c and glycaemic profile (blood sugar levels)Timepoint: from baseline to end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Quality of life (Physical, mental and social) General Health Questionnaire-28 (GHQ-28) Changes in mood behavior Sleep quality questionnaire Perceived stress questionnaire Safety profiling by LFT, RFT, TFT and lipid profile Assessment of Overall Improvement by subject and investigator Palatability with dosage compliance of test product Percentage of participants with adverse events Changes in the vitals Tolerability of study supplements Changes in laboratory parametersTimepoint: from baseline to end of study | — |
Countries
India
Contacts
Public ContactDr Priya Khare
Netsurf Research Labs Pvt Ltd
Outcome results
None listed