Health Condition 1: E11- Type 2 diabetes mellitus Health Condition 2: E139- Other specified diabetes mellituswithout complications Health Condition 3: E66- Overweight and obesity Health Condition 4: O992- Endocrine, nutritional and metabolic diseases complicating pregnancy, childbirth and the puerperium Health Condition 5: E282- Polycystic ovarian syndrome Health Condition 6: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention1: Whey Protein: 5g of whey protein to be dissolved in 100 mL of water to be consumed within 2 hours of preparation for twice daily
Control Intervention1: Standard Care of Treatment: N/AP
Sponsors
Crest Innovations
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients with metabolic issues like Obesity, Diabetes, Gestational Diabetes, Pre-diabetes, Poly Cystic Ovarian Disease and Non-Alcoholic Fatty liver 2.Selected patients will have insulin resistance irrespective of the condition that they clinically exhibit, therefore all of them will be assessed for HOMA-IR 3.HOMA-IR cut off values for each of the metabolic disease Type 2 Diabetes with greater than or equals to 2.4 of HOMA IR cut off value, Obesity with 2.5 of HOMA IR cut off value, PCOS with greater than 3 and plus or minus of 1.7 ,Gestational Diabetes greater than or equal to 1.8 to 1.9,Non-Alcoholic Fatty Liver Disease greater than or equals to 2.0 4.Patients with obesity will be selected on measurements of BMI, hip to waist ration, weight 5.The subject should have the means and willingness to follow the diet plan and the exercise regime (only workable diet plans with the consensus of the subjects and exercise regimes that would be easy to do will be prescribed)
Exclusion criteria
Exclusion criteria: 1.Subjects who have lactose intolerance 2.Subjects should not be on a course of insulin as part of their treatment regimen 3.Subjects with IBS 4.Patients with migraine (PCOD is often associated with migraines and such patients would have difficulties in following the diet and exercise program prescribed. 5.Subjects who smoke or drink more than 3 drinks a week 6.Subjects with other chronic ailments like osteoporosis. 7.Subjects with Gastroenteritis 8.Subjects who could suffer from cancer, benign growth etc. 9.Subjects with diabetic complications 10.Subjects with long-term diabetes. 11.COPD/asthma or other lung conditions that require steroid administration. 12.Any condition that requires long term steroid administration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in HOMA-IR from initial observed value at the end of studyTimepoint: Initial value before participation and final observed value at the end of 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety of product administrationTimepoint: entire study period of 16 weeks | — |
Countries
India
Contacts
Public ContactHilda Nirmala Kumari
Maaruthi Medical Centre and Hospital
Outcome results
None listed