None listed
Conditions
Brief summary
There has been a recent growing interest in the use of protein supplementation in type 2 diabetes (T2DM) therapy. Dietary amino acids are potent stimulators of vascular and skeletal muscle adaptations that have been associated with improved cardiovascular health and metabolic flexibility. Previous studies have typically derived these dietary amino acids from dairy sources; alternatively, keratin- derived protein (KDP) is uniquely rich in the amino acid cysteine and has high levels of selenium — both key components in glutathione, a critical agent in cellular antioxidant processes. Preliminary findings suggest that KDP supplementation may aid the attenuation of oxidative stress in diseased (e.g. T2DM) skeletal muscle leading to attenuation in muscle-degradative stress and fibrosis. Therefore, the current study will determine whether chronic KDP supplementation enhances the effects of 12 weeks exercise training on systemic glucose disposal and insulin signalling in middle-aged adults with T2DM. The findings may provide a new simple and practical direction for improving diabetic rehabilitation.
Interventions
Participants will be randomly allocated to 1 of 3 dietary supplementation groups: 1) wool derived protein, 2) whey protein, or 3) placebo. The study duration will be 17 weeks, which includes an initial two testing weeks, 14 weeks of exercise and protein supplementation co-intervention and a final testing week.. For the 2 week familiarisation, all participants will consume the placebo. The supplement will only be consumed during weekdays, to coincide with the exercise sessions.
Supplement: will
Participants will be randomly allocated to 1 of 3 dietary supplementation groups: 1) wool derived protein, 2) whey protein, or 3) placebo. The study duration will be 17 weeks, which includes an initial two testing weeks, 14 weeks of exercise and protein supplementation co-intervention and a final testing week.. For the 2 week familiarisation, all participants will consume the placebo. The supplement will only be consumed during weekdays, to coincide with the exercise sessions. Supplement: will be delivered in the form of health bars and capsules, to be consumed 2 times per day (post-exercise, 1 hour prior to bedtime), separated by at least 3 hours. The total daily protein dose in each treatment arm will be 40 gram: a) 17 g KDP+23 g whey, b) 40 g whey, or c) placebo - no added protein. The placebo bars will have the supplemental protein energy content replaced with gluten free flour and refined carbohydrate (maltodextrin, glucose) and fat to match energy and minimize protein content. Exercise: Exercise Physiologists will supervise 5 days/week intermittent high-intensity mixed-mode, group-based exercise program designed to achieve a fixed-rate 2% gain in exercise load/week. Each training session will be approximately 60 minutes in duration, including: a. Warm-up:10 min light cardio machine exercise and stretching b. Days 1, 2, 4, 5: aerobic (stationary cycle) exercise, comprising a mix of continuous exercise and anaerobic intervals (70-90% of peak power and recovery at 40-50% of peak power). Exercise intensity will be standardised by having all sessions conducted on calibrated ergometers c. Day 3: standardised circuit resistance training (10-30% of the exercise 1 repetition maximum) emphasising the legs d. Cool-down: 5-10 minutes of stretching to cool down Subjects will be required to attend a minimum of 60 sessions over the 14 weeks, and will be provided with the opportunity to complete any missed sessions on weekends. To ensure adherence to exercise the participants will be supervised. The participants will be required to complete a 3-day dietary recall each time they visit the laboratory for testing, and a text message will be sent to remind the participant to consume the evening dose.
Sponsors
Massey University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
35 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Thirty-six men and women with non-insulin dependent Type-2 diabetics (diagnosed for a minimum of 1 year), aged 35-70, BMI 25-40, HbA1c >48 mmol/mol, stable weight and not having participated in regular exercise in the past 6 months
Exclusion criteria
Exclusion criteria will include; use of beta-blockers, moderate to severe retinopathy, nephropathy and neuropathy, history of cerebrovascular or cardiovascular diseases, current smoker or having smoked 6 months prior.
Outcome results
None listed