None listed
Conditions
Brief summary
Skeletal muscle in Type 2 Diabetics (T2DM) exhibits a number irregularities which may act as barriers to insulin signalling and glucose handling, including: decreased skeletal muscle mass, oxidative stress, decreased microvascular blood flow, and decreased mitochondrial content. Dietary amino acids stimulate vascular and skeletal muscle adaptations that have been associated with improved metabolic flexibility. Previous studies have typically derived these dietary amino acids from dairy sources; alternatively, wool derived protein (WDP) is rich in selenium and in precursor amino acids found in glutathione, both critical agents in cellular antioxidant processes. Preliminary findings in rats suggest that WDP supplementation attenuates oxidative stress and improves metabolic flexibility. Therefore, the current study will determine whether chronic WDP supplementation enhances the effects of exercise training on systemic glucose disposal and insulin signaling. Further, we will investigate mechanic pathways, including antioxidant capacity and free-radical stress, microvascular blood flow and capillarity, and mitochondrial respiratory function. These findings may support a novel, cost-effective and practical intervention for T2DM rehabilitation.
Interventions
Longitudinal clinical trial, utilizing a randomized double-blind cross-over design. The study duration will be 22 weeks, consisting of:
Weeks 1-4: normalization (exercise + placebo)
Week 4-5: baseline testing (no exercise / no supplementation)
Week 5-13: Block 1: 8 week exercise plus supplement (placebo or wool derived protein) intervention
Week 13-14: 1 week washout period for testing (no exercise / no supplementation)
Week 14-22: Block 2: 8 week exercise plus supplement (placebo or wool deri
Longitudinal clinical trial, utilizing a randomized double-blind cross-over design. The study duration will be 22 weeks, consisting of: Weeks 1-4: normalization (exercise + placebo) Week 4-5: baseline testing (no exercise / no supplementation) Week 5-13: Block 1: 8 week exercise plus supplement (placebo or wool derived protein) intervention Week 13-14: 1 week washout period for testing (no exercise / no supplementation) Week 14-22: Block 2: 8 week exercise plus supplement (placebo or wool derived protein) intervention Week 22: post-intervention testing Normalization: Participants will commence the exercise programme during this period, and all participants will consume the placebo supplement before and after each exercise sessions, and again mid-afternoon. On week 4 all primary (glucose infusion rate) and secondary outcome measurements will be taken, and used as the pre-intervention time-point Randomization: participants will be allocated to begin the study with either WDP or placebo using the Minimisation method of randomisation. Supplement: The supplement will be delivered as a chocolate-milk like drink and health bar, to be consumed 3 times per day (pre-training, post-training, mid-afternoon). Each serving of the protein supplement will contain 18 g wool derived protein, 10-25 g carbohydrate, 2-4 g fat. To ensure adherence the participants will be required to complete a 3-day dietary recall each time the visit the laboratory for testing. The supplement will only be consumed on the exercise days, and not during non-exercise days. Exercise: Exercise Physiologists will supervise 5 days/week intermittent high-intensity mixed-mode, group-based exercise program designed to achieve a fixed-rate 1% gain in exercise load/week. Each training session will be approximately 60 minutes in duration, including: Warm-up:10 min light cardio machine exercise and stretching Days 1,3, 5: aerobic (stationary cycle) exercise, comprising 10 x 1-min intervals (70-90% of peak power) Days 2, 4: circuit training (10-30% of the exercise 1 repetition maximum) emphasising the legs Cool-down: 5-10 minutes of stretching to cool down Subjects will be required to attend a minimum of 36 sessions over the 8 weeks, and will be provided with the opportunity to complete any missed sessions on weekends. Compliance: The participants will be asked to wear an accelerometer for 7 days, and complete 3-day diet diaries on at baseline (week 4), block 1 (weeks 9 and 13), block 2 (weeks 18 and 22).
Sponsors
Massey University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
35 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
BMI 25-40, HbA1c 7-9%, stable weight and not having participated in regular exercise in the past 6 months
Exclusion criteria
use of beta-blockers, moderate to severe retinopathy, nephropathy and neuropathy, history of cerebrovascular or cardiovascular diseases.
Outcome results
None listed