Healthy
Conditions
Brief summary
The aim of the present study is to investigate effects of milk on body composition and muscle strength, inflammation, appetite, DNA damage/repair and PBMC whole genome transcriptomics in elderly subjects.
Interventions
DIETARY_SUPPLEMENTMilk
4 dl milk will be consumed daily with breakfast and supper for 12 weeks
DIETARY_SUPPLEMENTPlacebo
Sponsors
The Research Council of Norway
Tine
Oslo Metropolitan University
Norwegian School of Sport Sciences
University of Oslo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* ≥ 70 years of age * reduced gait speed or * reduced five times sit to stand test or * reduced timed step stair test or * reduced grip strength * Stable body weight (last 3 months) * Mini Nutritional Assessment (MNA®) score ≥ 17 * Mini-mental status (MMSE-NR) score: ≥ 24 * Willing to participate according to the protocol
Exclusion criteria
* Allergy/intolerance to milk/dairy products * High intake of milk and yoghurt * Physical active subjects * Known diabetes type I or II, or HbA1c ≥ 6,5% * Recent events of acute cardiovascular disease including stroke * Rapidly evolving diseases (active malignancy) or history of cancer (malignant tumors) last 3 years. * Severe inflammation-related diseases such as e.g. Crohn disease and arthritis * Chronic obstructive pulmonary disease * Increased blood pressure * High intake of alcohol * Reduced kidney function (GFR \< 45 ml/min) * Increased hsCRP, ASAT, ALAT * Increased or suppressed TSH * Hormone therapy * Systemic use of glucocorticosteroids (anti-inflammatory steroid hormones). Use of spray and inhalator use is not exclusion. * Disability preventing physical tests * Using medications known to affect protein metabolism
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in muscle mass, strength and performance | Measured at baseline and after 12 weeks (end-of-study visit) | Change in muscle is mass measured by DXA. Muscle strength and performance are measured by several physical tests such as repeated chair stands, handgrip strength, step stair test and strength in legs and torso and gait speed and are considered as the clinical relevant outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in levels of inflammatory markers | Measured at baseline and after 12 weeks (end-of-study visit) | Changes in levels of inflammatory markers in circulation and at PBMC gene Expression Level such as i.e. CRP, IL-6, TNFa, IL-8, IL-18, ICAM, VCAM. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Effect on PBMC whole genome transcriptomics | Measured at baseline and after 12 weeks (end-of-study visit) | Measurement of PBMC Whole genome transcriptomics will be performed. |
| Changes in body composition (including bone mineral density) | Measured at baseline and after 12 weeks (end-of-study visit) | Changes in body composition are measured by DXA. |
| Changes in the level of appetite regulatory hormones | Measured at baseline and after 12 weeks (end-of-study visit) | Changes in the level of appetite regulatory hormones such as i.e. adiponectin, glucagon-like protein (GLP-1), gastric inhibitory polypeptide (GIP), ghrelin, Peptide YY (PYY) and cholecystokinin (CCK) |
| Changes in the Lymphocyte DNA damage and repair system | Measured at baseline and after 12 weeks (end-of-study visit) | Changes will be measured using Whole blood and PBMC. |
Countries
Norway
Outcome results
None listed