An interventional study of Resistance Exercise and Protein supplementation in Sarcopenia, Dietary Protein and Resistance Exercise, sponsored by University of Birmingham. Completed at 1 site in United Kingdom. Open to participants aged 50 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-01.
Sponsored by University of Birmingham · Not applicable, Interventional, and Basic science
Dietary proteins potently augment muscle protein synthesis. Because of poorer anabolic sensitivity with ageing, studies and guidelines recommend higher dietary protein intake for older adults. Although higher doses would benefit skeletal muscle remodelling, large protein consumption is not feasible for many older adults. To circumvent, high-protein quality which possesses a high amino acid profile and digestibility appears to have an emergent role for supporting anabolism. Since currently the best line of defence against age related muscle loss is resistance exercise training and regular protein consumption, emphasising high-quality protein ingestion, such as whey protein, within meals may be feasible and efficacious in supporting musculoskeletal remodelling in older adults, without requirement for large protein doses.
The investigators propose that at low doses, high quality protein will have additive benefit to muscle protein synthesis compared to low-quality protein. Further, combining high-quality protein diets with resistance exercise training will have more profound benefits for muscle protein synthesis and muscle remodelling more so than low-quality protein diets.
Participants will be randomly assigned to a 10-day dietary intervention consuming primarily animal proteins (high-quality condition) or primarily plant proteins (low-quality condition). In both conditions, participants will undertake supervised single-leg resistance exercise training every other day, amassing five days resistance exercise sessions during the study. The groups will aim to be matched and counterbalanced for gender. Equally for unilateral exercise randomisation for leg dominance will aim to be counterbalanced within both groups.
Preliminary assessments:
5 days preceding the start of the dietary intervention, participants will report to the University of Birmingham, Sport, Exercise and Rehabilitation Science for the following:
2 days preceding the start of the dietary intervention, participants will report to the University of Birmingham, Sport, Exercise and Rehabilitation Science for the following:
Dietary intervention each day throughout 10-day intervention participants will provide a saliva sample and then consume a top up dose of D2O, continue wearing an activity tracker and keep a diet diary to record eating times of provided meals.
Meals will be individualised to body weight for each individual to achieve a moderate protein intake of which will then consist of primarily higher quality or lower quality proteins.
Day 0 (first day of diet), participants will report to the University of Birmingham, Sport, Exercise and Rehabilitation Science at 0800h after fasting >10 hours the night prior for the following:
After consuming specified breakfast on this visit, participants will continue to eat meals given to them according to their random allocation of either higher or lower quality protein diets.
Day 1, 3, 5, 7, 9
Participants will report to the University of Birmingham, Sport, Exercise and Rehabilitation Science to undergo single-leg resistance exercise on a knee extension machine. Eight sets will be completed on the machine at each visit at 75% of 1RM (determined during preliminary visits and will be supervised).
On day 9, the participant will be given a urine collection tub to collect urine over the next 24-hours.
Day 10 (Diet finishing during this visit), participants will report to the University of Birmingham, Sport, Exercise and Rehabilitation Science at 0800h after fasting >10 hours the night prior for the following assessments:
1,242 studies on the registry are indexed under Sarcopenia; 405 are open to participants now.
This study's enrollment of 30 is below the median of 60 across 793 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →University of Birmingham is the lead sponsor of 182 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
Participants will consume four high-quality protein containing meals per day (amounting to 1g/kg/day of protein) over a 10-day period. Each meal will contain 75:25 animal:plant protein with most of the animal protein from supplemental high-quality protein powder.
Other: Resistance Exercise · Dietary Supplement: Protein supplementation
Participants will consume four low-quality protein containing meals per day (amounting to 1g/kg/day of protein) over a 10-day period. Each meal will contain 25:75 animal:plant protein with most of the plant protein from supplemental low-quality protein powder.
Other: Resistance Exercise · Dietary Supplement: Protein supplementation
Supervised single-leg (unilateral) exercise will be undertaken every other day throughout the dietary intervention
Also known as: Single-leg resistance exercise
Participants will consume a protein supplement alongside a provided diet to control protein amount and quality.
Muscle protein synthesis using muscle biopsies and deuterated water enrichment.
Muscle protein synthesis will be assessed during the high-quality and low-quality intervention and compared between exercised and controlled leg.
Time frame: 0-10 days
Leg Strength using dynamometry
Evaluating change in leg strength, of trained leg, pre- and post-intervention with high-quality and low-quality protein condition
Time frame: 0-10 days
Neural activation using interpolated twitch
Assessing change in neural activation via non-invasive interpolated twitch technique of between exercised legs pre-and post intervention in both protein quality conditions
Time frame: 0-10 days
Muscle architecture using ultrasound
Using non-invasive ultrasound to determine change of muscle structure with training between protein quality conditions.
Time frame: 0-10 days
Appetite regulation using questionnaires
Assessing perceived hunger using a validated, 8 question, 100mm visual analogue scales.
Time frame: 0-10 days (3 hours postprandial)
Appetite regulation, blood
Assessing the secretion of hunger and appetite hormones within the blood after meals which contain high-quality versus low-quality protein.
Time frame: 0-10 days (3 hours postprandial)
Metabolic rate, metabolic cart
Evaluating alterations in energy expenditure before and after high-quality or low-quality protein containing meal using a metabolic cart.
Time frame: 0-10 days
Nitrogen balance from urine and dietary protein intake
Evaluating change in nitrogen balance between adhering to high-quality or low-quality protein diets over a 10-day period
Time frame: 0-10 days (24-hour urine collection)
Body composition using Duel- energy x-ray absorptiometry (DXA) scan.
Change in body composition (muscle mass, fat mass, bone mineral density) will be evaluated using a DXA scanner before and after adhering to single leg resistance exercise paired with either high-quality or low-quality protein diet.
Time frame: 0-10 days
Muscle fibre specific analysis using immunofluorescence microscopy.
Evaluate changes in fibre specific differences in the distribution and localisation of key anabolic markers between trained and untrained legs for both protein quality conditions.
Time frame: 0-10 days
Intramuscular signalling using western blotting
Evaluate changes in protein content and phosphorylation from the start to the end of the intervention.
Time frame: 0-10 days
Physical activity levels using accelerometery and pedometer
Monitoring of habitual and habitual physical activity to evaluate if intensity and duration of activity is similar between habitual and intervention.
Time frame: -5-10 days
Ran from Nov 2021 to primary completion in Dec 2023, 25 months.
Of 474 non-industry interventional studies with no phase under Sarcopenia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 34. This study's 25 months is above that.
Counting every sponsor, half of 485 studies reached it within 18 months; a quarter within 8 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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