CTRI/2024/03/064441RecruitingPhase 4
A Prospective, Open label, Randomized, Controlled, Three-Arm, Comparative Study to Determine the Effect of high protein supplement on muscle strength, muscle mass and physical function in elderly population.
Hindustan Unilever Limited3 sites in 1 country120 target enrollmentStarted: March 28, 2024Last updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Hindustan Unilever Limited
- Enrollment
- 120
- Locations
- 3
- Primary Endpoint
- To determine the effect of a protein supplement with lifestyle counselling versus lifestyle counselling alone on muscle strength or physical function on elderly participants after a 12 week period of consumption.
Study Overview
Brief Summary
The study is a randomized, open label, controlled, parallel, three arm study. One twenty adults men and women aged greater than or equal to 60 years or above with body mass index BMI between 20.0 and 32.5 kg/m2 will be included in the study. Each arm will have 40 participants. The protein supplementation will be given for 24 weeks post randomization. Participants will be divided into 3 equal groups comprising 40 participants each. The 3 groups will be assigned to either of the 3 arms (1, 2, 3) sequenced according to the randomization schedule and subject has to visit at site on Day 1, Day 28, Day 56, Day 84, Day 112, Day 140 and Day 168 .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 60.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •Participants who have had significant weight loss or gain in the past 6 months.
- •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.
- •Participants who regularly uses non-steroidal anti-inflammatory drugs or anticoagulants.
- •Participant with any known food allergy (particularly milk) or intolerance to any food or beverages.
- •Any participant who has taken part in a clinical trial in the past 90 days.
- •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.
- •Participants who have had any surgery in the past 6 months will be excluded.
- •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.
- •The participant(s) must also not be related to any personnel conducting the study.
- •Participants consuming non-vegetarian foods (more than 2 a week) in their habitual diet.
Outcomes
Primary Outcomes
To determine the effect of a protein supplement with lifestyle counselling versus lifestyle counselling alone on muscle strength or physical function on elderly participants after a 12 week period of consumption.
Time Frame: Subject will visit at site on Day 1, Day 28, Day 56, Day 84, Day 112, Day 140 and Day 168
Secondary Outcomes
- 1. To determine the effect of a protein supplement with lifestyle counselling versus lifestyle counselling alone on muscle strength or physical function on elderly participants after a 24 week & period of consumption.(2. To determine the effect of a protein supplement with lifestyle counselling versus lifestyle counselling alone on muscle mass on elderly participants after 12- & 24-week of consumption.)
Investigators
Dr Sanjay Mishra
Rumedic Hospital
Study Sites (3)
Loading locations...
Similar Trials
Not yet recruiting
Phase 3 4
A Clinical Study to assess efficacy and safety of Green-Lipped Mussel Oil on joint health in older adults.CTRI/2024/06/068625Great HealthWorks, Inc.210
Recruiting
Phase 3
Study on Beta Glucan as a nutritional supplement in children undergoing chemotherapyCTRI/2024/10/075871MediNippon Healthcare Pvt Ltd40
Recruiting
Phase 3 4
To Study the Effect and Safety of Raktamrut Vati Along with Standard Treatment in People with Hemophilia.CTRI/2025/07/090910Dr. Shubham Ramnarayan Dhoot100
Recruiting
Phase 3
Effectiveness and safety study of Inj. Pembrolizumab in patients with Lung cancerCTRI/2025/07/090716Hetero Biopharma Limited228
Recruiting
Not Applicable
The Liquid Embolic Agent for the Treatment of Brain Arteriovenous MalformationArteriovenous FistulaNCT07314047MicroPort NeuroTech Co., Ltd.116