Health Effects of Milk Proteins in Elderly Subjects

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Milk; Dietary Supplement: Placebo

• Registration Number: NCT02218333
• Lead Sponsor: University of Oslo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-11
• Study First Submitted QC: 2014-08-15
• Study First Posted: 2014-08-18
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-15
• Last Update Posted: 2015-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Milk	Milk	Protein enriched milk (Styrk)
Control drink	Placebo	An isocaloric drink to milk

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Oslo; 🇳🇴 Oslo, Post box 1046, Blindern, Norway