None listed
Conditions
Interventions
Intervention1: Horlicks Protein Plus and Horlicks Strength Plus: Product A (30 g of Horlicks Protein Plus) will be administered with 200 ml low fat milk
Product B (30 g of Horlicks Strength Plus) will
Sponsors
Dr Deepti Khanna
Eligibility
Inclusion criteria
Inclusion criteria: Participants fulfilling all inclusion criteria below will be considered for the study. 1. Healthy adult male or female participants aged greater than or equal to 25 and less than or equal to 60 years, will be considered. 2. Participants having a Body Mass Index (BMI) in the range 20.0 to 30.0 kg/m2 (both inclusive) and weight of at least 50 kg will be considered. 3. Participant with normoglycemia which means fasting plasma glucose (FPG) less than 100mg/dl (as per ADA guidelines) will be considered. 4. Women in the reproductive age group if non-lactating and having negative test for pregnancy will be considered for the study, 5. Participant should not have taken part in a clinical trial in the last 3 months. 6. Participant should be able to read and understand and ready to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.Participants having resting hypotension i.e., BP less than 90 and 60 or hypertension BP more than 139 and 89 will be excluded. 2.Participants having pulse rate below 50 per min. and above 99 per min will be excluded. 3.Participants with known medical history of any of the conditions listed below, will be excluded. A. food allergy including lactose intolerance. B. drug abuse or alcoholism i.e., alcohol consumption more than 2 units per day or 10 units per week one unit of alcohol 50 ml spirit or 200 ml wine or 500ml beer. C. smoking or tobacco consumption. D. diabetes and hyperglycaemia. E. intake or administered protein supplements or any drugs or over the counter or prescribed medications including any enzyme modifying drugs in the last 14 days prior to the study. F. illness or has been hospitalized in the last 4 weeks preceding the start of the study. G. gastrointestinal, liver or kidney disease, or presence active peptic ulceration or a history of peptic ulceration or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects. 4.Potential participants who are related e.g., husband and wife or brother and sister or persons living in the same household e.g., tenants sharing a household cannot be recruited together in the study one of participants will be excluded. 5.Participants following any protein-rich dietary regime, muscle toning or body building program and not willing to discontinue such regime or program during the conduct of study will be excluded. 6.Any potential participant who is an employee of Sponsor, or the site CRO conducting the study will be excluded. The participants must also not be related to any personnel conducting the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of Protein Supplements on the Essential Amino Acid (EAA) Levels in healthy adultsTimepoint: There are a total of three visits scheduled on Day 1, Day 9, and Day 17. During each visit, samples will be collected at predose and at 15, 30, 60, and 90 minutes after the administration of the product. | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in the level of each TSAA, post supplementation between the arms will be considered for significance i.e., change between the arms Arm1 with Placebo & Arm 2 with Placebo.Timepoint: There are a total of three visits scheduled on Day 1, Day 9, and Day 17. During each visit, samples will be collected at predose and at 15, 30, 60, and 90 minutes after the administration of the product. | — |
Countries
India
Contacts
Public ContactDr Deepti Khanna
Auriga Research Private Limited
Outcome results
None listed