None listed
Conditions
Interventions
Intervention1: NRL/2019/NMP: 20 g in 200 ml milk once a day for 90 days
Control Intervention1: placebo: 20 g in 200 ml milk once a day for 90 days.
Sponsors
Netsurf Communications Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age group: 25-45 years 2.BMI in the range of 20-26 3.Subjects in good physical condition and sound mental status. 4.In the judgment of the Principal Investigator, able to comply with protocol requirements. 5.Subjects willing to sign written informed consent 6.Willingness to abstain from use of vitamin or mineral supplements, nutritional supplements and or medical foods if applicable.
Exclusion criteria
Exclusion criteria: 1.Allergies to ingredients in product/ milk 2.Subjects with uncontrolled and complicated diabetes (HbA1C NMT 5.7% and blood pressure NMT 140/90 mm hg) may or may not be on prescription. 3.Subjects with past history of addiction abuse and rehabilitation 4.Subject more than 2 events of alcohol consumption per week 5.Subjects with current medical history of any major illness such as cancer, heart disease, COPD , Asthma etc. in the past 6.Subjects with history of any acute or chronic illness that may affect the patientââ?¬•s participation in the study 7.Use of prescription medications and/or nonprescription medications for weight loss. 8.Subjects with acute illness or history of major or minor surgery in the past one year. 9.Female subjects who are currently pregnant and/or breast feeding 10.Subjects not willing to participate in study 11.Subjects with deranged LFT and KFT as per investigator discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes mean in total General Health Questionnaire-28 (GHQ-28) score. Changes in mean serum total protein, and albumin to globulin ratio. Changes in mean calculated VO2 max by 6-minute walk test. Changes in mean BMI, fat %, skeletal muscle %, through impedance studies for body composition along with waist and hip circumferences.Timepoint: Screening Baseline Day 30 Day 60 Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in % responders (subjects showing reduction of 25% of low energy scores in 30 daysââ?¬â?¢ time) on daily energy questionnaire. Changes in mean total digestive behavior score. Changes in mean total sleep quality score. Changes in mean Bone Mineral content, Bone mineral density, fat content analyzed by DXA scanning for body composition.Timepoint: Screening Baseline Day 30 Day 60 Day 90 | — |
Countries
India
Contacts
Public ContactDr Pranit Ambulkar
Netsurf communication pvt ltd
Outcome results
None listed