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Effects of 12-week dairy-derived nutritional supplementation combined with physical activity on health and physical function in healthy middle aged women after a 2-week period of reduced activity

Effects of 12-week dairy-derived nutritional supplementation combined with physical activity on health and physical function on healthy middle aged women after a 2-week period of reduced activity

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001714471
Acronym
NExT
Enrollment
92
Registered
2016-12-14
Start date
2016-01-27
Completion date
2016-09-02
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

After the age of approximately 40 years there is a progressive decline in physical function as well as bone, muscle and general health. Recent evidence indicates that some of these changes might be slowed or reversed with appropriate intake of nutrients such as proteins, calcium and vitamin D. However, whilst the effects of these nutrients have been quantified in older individuals (e.g. >65 years of age), no research has determined whether effects are present in younger (e.g. 40 - 60 years of age) individuals. Dairy foods such as milk contain these essential nutrients, and the processing of milk allows for the development of nutritional supplements with higher levels of them. Our hypothesis is that a dairy-derived supplement (fortified milk product, FMP) that is high in protein, calcium and vitamin D will improve physical function as well as bone, muscle and general health in 40 - 60 year-old women. Because the combination of dietary supplements with exercise, which normally forms part of a healthy lifestyle, has been shown to improve health outcomes after supplementation, we will compare the effects of the FMP supplement to a placebo powder (PLA) when taken twice daily during a 12-week period while completing prescribed exercise sessions four times a week. Additionally, because periods of physical inactivity are common in this age group (e.g. due to work and family commitments or short-term illness), we will first impose a 2-week period of reduced physical activity before introducing the exercise (i.e. healthy lifestyle) program and supplementation or placebo.

Interventions

Participants will be randomised into 2 treatment groups and progress through 2 phases (Phase 1 = 2 wk reduced activity; Phase 2 = 12 wk exercise + supplementation intervention). In Phase 1 the participants will aim to reduce their physical activity to below 1500 steps per day. During this period the participants will: (1) spend the majority of their day engaged in sedentary behaviour (i.e. activities with energy expenditure close to the resting level of 1.0-1.5 metabolic equivalent units (METs)

Participants will be randomised into 2 treatment groups and progress through 2 phases (Phase 1 = 2 wk reduced activity; Phase 2 = 12 wk exercise + supplementation intervention). In Phase 1 the participants will aim to reduce their physical activity to below 1500 steps per day. During this period the participants will: (1) spend the majority of their day engaged in sedentary behaviour (i.e. activities with energy expenditure close to the resting level of 1.0-1.5 metabolic equivalent units (METs), including activities such as sleeping, sitting, lying down, watching television, and other forms of screen-based entertainment, (2) spend less than 90 min per day engaged in light activity (energy expenditure of 1.6-2.9 METs, including activities such as slow walking, cooking food and washing dishes), and (3) refrain from moderate and high intensity activity. Steps will be recorded each day using a pedometer to assess compliance. To determine energy expenditure across this period an accelerometer will also be worn daily (attached to the waist belt), and 7-day IPAQ questionnaires will be completed. A 3-day weighed diet record will also be completed, and testing will be completed, before and after this 2-week phase of reduced activity. In Phase 2, commencing immediately after Phase 1, the participants will begin supplementation with a fortified milk powder (FMP) or a placebo (PLA), and complete a 12-week structured physical activity (i.e. healthy lifestyle) programme that will include four training sessions a week: two university-based (strength, balance and flexibility training done in a group/social environment) sessions completed in small groups of up to 8 participants as well as two home-based (calisthenics, balance and flexibility training) sessions performed individually. The exercise programme will include elements of traditional strength and flexibility training programmes alongside aspects taken from yoga, Pilates, body balance and other popular forms of exercise. For the university-based gymnasium exercise program, the participants will complete 50 min of broad-based exercise training including muscle stretching, balance, muscle strength and physical fitness/endurance exercises. The sessions will commence with mobility and muscle stretching exercises (15 min). Fitness and muscle strength training will then follow, and the session will conclude with a short (5 min) stretch and warm-down period. Strengthening exercises (20 min) focusing on a holistic approach, but targeting the lower limb, will be incorporated into all sessions; examples include body-weight squat and lunge movements, although leg extension exercises performed on a machine will be incorporated. The strengthening exercises will be completed as a circuit format with 45 seconds work to 15 seconds of rest. Within those 45 seconds, 10-15 reps will be performed at an intensity of 14-15/20 RPE. For the fitness/endurance component (8 min per session), participants will perform stair climbing (4 and 3 min bouts with 1 min rest) or cycling, rowing and/or walking/running at a ‘moderate intensity’ in intervals with a 1:3 high- vs. low-intensity work ratio (e.g. cycle 15 s on level 12 then 45 s at level 4). All trainers will have a minimum of a degree level qualification in Exercise and Sport Science. At home the participants will perform a basic 20 - 30 min session that mirrors the movements and exercises performed in the gymnasium but which can be achieved without supervision or equipment. A reference sheet with photographic explanations will also be supplied as further reference. They will begin with a 10 minute warm up of active range of motion exercises, and then perform ~10 minutes bodyweight-resistance exercises. These resistance exercises cover 4 different movements. One set of each is to be completed to be completed to as many repetitions as possible. The intensity of these body weight exercises will therefore begin very light and then peak with a final repetition around 17-20/RPE. During Phase 2, the participants will also complete at least 3000 steps per day on ‘non-exercise’ days. In this phase of the project we will determine whether daily supplementation with a dairy-derived nutritional supplement provides greater health, mobility/physical function and vitality outcomes than physical activity alone, and thus whether this nutritional strategy might be adopted in 40 – 60 year-old women seeking to improve their health and well-being. The participants will be tested after 6 and 12 weeks of the programme. Phase 2 treatment arms: 1. Fortified Milk Powder, 30 g dose, 2 x per day; total dose 60 g/day [FMP]. The FMP supplement is largely comprised of milk powder (skim and whole), vitamins, minerals, complex milk lipids, maltodextrin and a small amount of hydrolysed fish collagen. It also contains low levels of Vitamins B12, B6, E and C. 2. Placebo, 30 g dose, 2 x per day; total dose 60 g/day [PLA] - see 'Comparator / Control treatment' for details. Assessment of compliance to supplementation The participants will receive their supplement (FMP or PLA) sachets in four installments, with a new batch every 3 weeks. The first group of sachets (along with ingestion guidelines) will be dispensed to the participants at the first testing session prior to Phase 2. To ensure supplementation compliance, the participants will be required to return all used and unused sachets every 3 weeks. A log of the sachets dispensed (out) and sachets returned (in) will be kept for each participant and the balance calculated.

Sponsors

Anthony Blazevich
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
40 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

1. age = 40-60 y 2. Female 3. BMI (18 -35 kg/m2) 4. Sedentary to moderately active 5. Healthy

Exclusion criteria

1. Previous negative reaction to milk or dairy proteins 2. Previous negative reaction to fish 3. Currently perform structured physical activity in their occupation 4. Baseline protein above 1.2 g/kg/day 5. Calcium intake of > 750 mg/day 6. Alcohol > 14 drinks per week (average) 7. Smoking (or only having stopped smoking within the last 2 years) 8. T-score bone mineral density (BMD) at either the hip or lumbar spine < -2.5 9. Have any fixations (i.e. spine or femoral rods, hip replacements) 10. Irregular menstrual cycle (not within 20-35 days); lack of cycle is not a criterion 11. Using hormone replacement therapy 12. Planning to become pregnant or currently breastfeeding 13. Using supplements such as vitamin D (>400 IU), calcium, bone/joint assistants (glucosamine, chondroitin), or antacids containing calcium carbonate, and not willing to stop for at least 6 weeks prior to, and throughout, the duration of the trial. 14. Anti-inflammatory use (including aspirin, ibuprofen, omega 3) 15. Rheumatoid arthritis 16. Use of beta blockers or ACE inhibitors 17. Metabolic bone disease (including osteoporosis, osteomalacia, osteogenesis imperfect and Paget’s disease) 18. Endocrine disorders (including hyper- or hypo-thyroidism, parathyroid disease, diabetes mellitus and Cushing’s syndrome) 19. Cancer (including cervical, ovarian, uterine, breast, liver and of the gastrointestinal system) 20. Other medical conditions impacting on digestion, including diseases of the gastrointestinal tract, or previous operations such as gastrectomy or intestinal resection, or the liver (i.e. cirrhosis). 21. Any chronic muscle disease, disorder or injury 22. Asthma that is not controlled or other respiratory diseases 23. Self-reported personal or family history of deep vein thrombosis or similar clotting disorders

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026