None listed
Conditions
Brief summary
Aging is associated with loss of muscle mass and this accelerates after 60 years of age, even in healthy individuals. This is undesirable, as loss of muscle mass is strongly associated with sarcopenia, increased morbidity and mortality and lower quality of life. Sarcopenia is the age related degenerative loss of skeletal muscle mass, quality, and strength. The cause of sarcopenia with aging is multifactorial, with declines in physical activity and poor nutrition, neuromuscular decline, hormonal changes, systemic inflammation and chronic illness, all being implicated. Interventions to enhance and maintain muscle mass are urgently needed. This study is a 16 week, randomised controlled trial for adults aged 65 years and over, who are at risk of sarcopenia due to a low protein intake and sedentary lifestyle. Participants complete a home based resistance exercise training programme as well as consume either a high or low dose protein based nutritional drink. The aim of this study is to determine the efficacy of the combined nutritional and exercise approach in improving: • Body composition • Bone mineral density • Muscle strength and function • Muscle protein synthesis markers • Systemic protein markers • Systemic inflammation • Systemic gene expression of inflammatory/ muscle protein synthesis pathways We hypothesise that In an older population at risk of sarcopenia, greater improvements in fat free mass, bone mineral content, muscle strength and function can be achieved when a resistance exercise programme is combined with a high dose versus low dose protein based nutritional supplement drink.
Interventions
Participants will complete a resistance training home exercise programme 4 days per week for 16 weeks (see below) combined with a high dose protein drink:
250ml skim milk (can be lactose free or full cream milk, though must be cow’s milk) mixed with one whole sachet (37.5g) of the study nutritional supplement powder (Juice Plus+® Complete, French Vanilla Blend) , twice daily (after breakfast and after evening meal).
The study drink (skim milk ± study supplement) is to be consumed in addition t
Participants will complete a resistance training home exercise programme 4 days per week for 16 weeks (see below) combined with a high dose protein drink: 250ml skim milk (can be lactose free or full cream milk, though must be cow’s milk) mixed with one whole sachet (37.5g) of the study nutritional supplement powder (Juice Plus+® Complete, French Vanilla Blend) , twice daily (after breakfast and after evening meal). The study drink (skim milk ± study supplement) is to be consumed in addition to the normal background diet. No other changes will be made to the participant’s diet, they will be advised to continue usual intake at mealtimes and snacks. Resistance Training Programme: Participants will be prescribed a home-based upper and lower limb resistance training programme by a physiotherapist during their initial study visits. The exercise programme will be completed at home independently by the participant between study visits. The participant will return on a monthly basis for review of the programme with the physiotherapist, which will take approximately 1 hour to complete. The exercises will be completed 4 days per week and will take approximately 30-40 minutes to complete each time. Participants will be asked to complete RT exercises in the afternoon, an hour before their evening meal if possible. Specific exercises will include shoulder press, one arm dumbbell row, wall or floor level push ups, calf raisers, sit to stands or squats or lunges. Any musculoskeletal limitations to exercise will be assessed and considered in the prescription of the exercise programme. Load will be prescribed according to the participant’s 10-15 repetition maximum, equivalent to the highest weight the participant is able to lift through the full range of motion of the specified exercise 10-15 times, providing there is no pain reported, which will be re-assessed on a monthly basis during the face to face physiotherapist visits. Resistance will be in the form of hand weights. Progression of load will be advised based on the re-assessed 10-15 repetition maximum weight achieved. The load will only be upgraded under supervision monthly. Progression of the exercise may also involve increasing the effect of gravity for example wall push ups may be progressed towards floor level push ups. The participants will complete 3 sets of 10-15 repetitions. Participants will be advised to complete a diary of the home exercise programme to document what days the programme is completed. Juice Plus+® Complete, French Vanilla Blend, is classified as a Formulated Supplementary Food and is listed on the front of the label as this. The IP contains a fine, granular powder mainly consisting of protein, fibre and other carbohydrates. Adherence Adherence to the study intervention will be monitored and assessed at each visit through sachet countback and review of study diaries. Participants will be asked to fill out the diary each day by recording consumption of the study drink (skim milk ± study supplement) and completion of the home exercises four times per week. Telephone calls and monitoring of muscles mass by BIA during the intervention will be used to help improve adherence to the intervention.
Sponsors
The University of Newcastle
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Males and females; age 65 years or more
Exclusion criteria
BMI >40kg/m2 Usual dietary protein intake >1.0 g/kg BW/day Participation in resistance exercise (>1 wk), moderate-intensity exercise greater than or equal to 150 min/wk and/or vigorous exercise greater than or equal to 60 min/wk over the past 3 months Unwilling or unable to undertake resistance training exercise programme (eg severe osteoarthritis) Unwilling or unable to consume the study drink or cow’s milk Allergies or intolerance to soy (self-reported) Regular (>3 times per week) protein supplement (eg. Sustagen) use Medical conditions requiring a specialised dietary plan (eg insulin dependent diabetes) Current smokers (smoked within past 6 months) Abnormal blood chemistry panel at screening Chronic or excessive alcohol consumption (as evidenced by abnormal liver function tests) Significant weight loss (>5% BW) in the past 6 months Current use of systemic anti-inflammatory or immunosuppressant medications (eg corticosteroids) Current use of medication that may affect muscle metabolism (eg corticosteroids or thyroxine) Unstable cardiac condition Diagnosis of renal (eGFR<30) or hepatic failure; terminal illness, human immunodeficiency virus (HIV) or cognitive impairment (Mini mental state exam score <24). Any other medical condition which may interfere with the participant’s ability to participate in the intervention. For example a diagnosis of osteoporosis and a history of recent multiple non-trauma fractures.
Outcome results
None listed