None listed
Conditions
Interventions
Intervention1: Good Monk Healthy H50+: 2.3g of proprietary premix formulation of micronutrients, probiotics, essential amino acids and herbs to be consumed orally twice daily with food for 120 days.
I
Sponsors
Superfoods Valley Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male or female subjects in the age group of 50-70 yrs. with a Body Mass Index (BMI) between 18 to 29.9 kg/m2. 2. Subjects who meet at least any of the two important micronutrient deficiency (Vit.B12, Vit.D, Iron) and/or a gut related dysfunction or the combination of both. 3. Subjects, who are in good health conditions at the time of enrolment into the study as determined from medical history, physical examination and clinical judgment of the investigator. 4. Diabetic and Hypertensive subjects who are stable with the normal diet and regular concomitant medication and considered otherwise healthy by the treating Investigator.
Exclusion criteria
Exclusion criteria: 1. Subjects with the current habit or history of cigarette smoking and alcohol consumption. 2. Subjects with any known significant systemic disease/ disorder, i.e. hepatic, renal, oesophageal, gastrointestinal, cardiovascular, psychological, neurological etc. other than diabetes and hypertension. 3. Subjects on any seizure medication. 4. Subjects with a known history of any malignant disease. 5. Subjects with known history of autoimmune disease and other systemic diseases related to immune system or on any medication known to reduce immunoglobulin levels or with known chronic immune diseases like HIV, HBsAg, HCV, etc. 6. Subjects treated with the following medications: a) Antibiotics less than one week before the study b) Any vaccination less than 4 weeks before the study c) Concomitant immunosuppressive or immune-stimulating therapy 3 months before the study start. d) Concomitant medication/ therapy for gut related disorder/s. e) Concomitant medication/ therapy for micronutrient supplementation. 7. Subjects who participated in another clinical trial less than 3 months prior to this study. 8. Subjects with the history of consumption of any recreational drugs (such as cocaine, methamphetamine, marijuana, etc). 9. Subjects who are scheduled for any surgery within 3 months period of completing the study. 10. Subjects with inability or unwillingness to abide by the requirements of the protocol. 11. Subjects who are incompetent to sign an Informed Consent Form. 12. Any criteria, which in the opinion of the Investigator, suggests that the subject would not be compliant with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects showing improvement at the end of the study compared to the baseline through energy & mobility tests, gut health parameters, immunity and inflammatory biomarkers.Timepoint: 0 Day, 30 Day, 60 day, 90 Day and 120 Day | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects showing improvement at the end of the study compared to the baseline by assessing through micronutrient levels, mental & stress assessment tests and safety laboratory testsTimepoint: 0 Day, 30 Day, 60 day, 90 Day and 120 Day | — |
Countries
India
Contacts
Public ContactDr Shovan Ganguli
Superfoods Valley Private Limited
Outcome results
None listed