A Prospective, Open label, Randomized, Controlled, Three-Arm, Comparative Study toDetermine the Effect of high protein supplement on muscle strength, muscle mass andphysical function in elderly population. - Nil

Hindustan Unilever Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年5月27日

试验速览

暂无简介。

•1.Physically independent mobile men and post menopausal women above or equal to 60 years of age who are able to rise from a seated position to standing will be considered
•2.All participants below the cutoff for 30 second Chair Stand test 30CST will be included in the study 30SCST cutoffs more than 9 for men and more than 8 for women to be considered
•3.Participants having normal resting blood pressure or stage I hypertension systolic blood pressure BP greater than or equal to greater than or equal to 130 to 139 mmHg diastolic BP greater than or equal 80 to 89 mmHg will be considered
•4.Participants having BMI 20 to 32.5 kg per m2 will be considered
•5.Participants or diabetics on stable doses of oral hypoglycemic agents OHA for at least the last 3 months with glycated hemoglobin HbA1C less than or equal to 8 percent will be considered
•6.Participants with a normal liver function and or kidney function and CBC or abnormal values which are considered clinically non significant as per investigator
•7.The potential participant should not be on any structured resistance or aerobic exercise training program in the previous 6 months
•8.Participants should be willing and able to follow the study protocol and protocol related procedures to participate in the study
•9.Participants who can understand and provide written informed consent to participate in the study

•1. Participants who have had significant weight loss or gain in the past 6 months.
•2. Participants having history of having cancer, infectious diseases, unstable cardiac, and/or gastrointestinal disease or poorly controlled diabetes or on insulin injections for diabetes or having alterations of dosages of OHA in the last 3 months.
•3. Participants who regularly uses non-steroidal anti-inflammatory drugs or anticoagulants.
•4. Participant with any known food allergy (particularly milk) or intolerance to any food or beverages.
•5. Any participant who has taken part in a clinical trial in the past 90 days.
•6. Participants on an unusual diets or special diet, for whatever reason e.g., keto diet or any other high protein diet, low sodium diet, for two weeks prior to receiving any test product and throughout his/her participation in the study will be excluded.
•7. Participants who have had any surgery in the past 6 months will be excluded.
•8. 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 this study; one of them will be excluded.
•9. The participant is an employee of the Sponsor, or site (CRO) conducting the study. The participant(s) must also not be related to any personnel conducting the study.
•10. Participants consuming non-vegetarian foods (more than 2 a week) in their habitual diet.

发起方