Health Effects of Milk Proteins in Elderly Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 26 October 2015
• Main ID: NCT02218333
• Date of registration: 11/08/2014
• Prospective Registration: No
• Primary sponsor: University of Oslo
• Public title: Health Effects of Milk Proteins in Elderly Subjects
• Scientific title: Effect of Milk Proteins on Body Composition, Muscle Strength, Inflammation and Bone Health in Elderly Subjects
• Date of first enrolment: August 2014
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02218333
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Norway

Contacts

• Name: Kirsten Holven, Professor
• Affiliation: Institute of Basic Medical Sciences, Faculty of medicine, University of Oslo

Key inclusion & exclusion criteria

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



Age minimum: 70 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Dietary Supplement: Milk

Dietary Supplement: Placebo

Primary Outcome(s)

Change in muscle mass, strength and performance [Time Frame: Measured at baseline and after 12 weeks (end-of-study visit)]

Secondary Outcome(s)

Changes in levels of inflammatory markers [Time Frame: Measured at baseline and after 12 weeks (end-of-study visit)]

Secondary ID(s)

2014/150/REK sør-øst C

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The Research Council of Norway

Norwegian School of Sport Sciences

Oslo and Akershus University College of Applied Sciences

Tine