Health Effects of Milk Proteins in Elderly Subjects

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Milk Proteins on Body Composition, Muscle Strength, Inflammation and Bone Health in Elderly Subjects

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Milk
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control drink<br>An isocaloric drink to milk | Dietary Supplement: Placebo<br> <br> * Other names: Isocaloric drink;|
| Experimental: Milk<br>Protein enriched milk (Styrk) | Dietary Supplement: Milk<br>* 4 dl milk will be consumed daily with breakfast and supper for 12 weeks<br>* Other names: TINE Styrk milk;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscle mass, strength and performance | 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. | Measured at baseline and after 12 weeks (end-of-study visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in levels of inflammatory markers | 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. | Measured at baseline and after 12 weeks (end-of-study visit) |