Health Condition 1: E648- Sequelae of other nutritional deficiencies
Conditions
Interventions
None listed
Sponsors
DXN Manufacturing India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants aged 18-60 years (both sex). 2. Participants who are determined to be at risk for malnutrition based on the Malnutrition Screening Tool for adults and presenting with any one of the co morbidities like Systemic hypertension or Diabetes Mellitus or Hyperlipidemia.
Exclusion criteria
Exclusion criteria: 1. Participants presenting with fever and acute infections, will be excluded. 2. History of heart, liver or kidney failure. 3. Allergy or intolerance to the individual constituents in test product. 4. Patients with history of thyroid abnormalities. 5. Patients with history of any malignancy 6. History of any Neurodegenerative disease 7. Organ transplantation 8. Allergy to fungi 9. Subjects who are pregnant and lactating mothers, or with any serious disease condition limiting full adhesion to the protocol. 10. Participation in an investigational drug trial in the 30 days prior to the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Improvement in the nutritional status based on Malnutrition screening tool, Mini Nutritional assessment & DETERMINE Your nutritional health checklist. [Baseline, week 4] 2. Improvement in Cognitive function by using Montreal Cognitive Assessment [Baseline, week 4]Timepoint: Day 0 and 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Improvement in BMI and mid arm circumference and Various hematological and biochemical blood parameter will be monitored 2. Adverse event monitoringTimepoint: Day 0 and 28 | — |
Countries
India
Contacts
Public ContactDr Sakthi Balan MD
Ki3, CRO
Outcome results
None listed