Health Effects of Milk Proteins in Elderly Subjects

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02218333
• Other study ID #: 2014/150/REK sør-øst C
• Status: Completed
• Phase: N/A
• First received: August 11, 2014
• Last updated: October 15, 2015
• Start date: August 2014
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Milk
4 dl milk will be consumed daily with breakfast and supper for 12 weeks
• Placebo

Locations

Country	Name	City	State
Norway	University of Oslo	Oslo	Post box 1046, Blindern

Sponsors (5)

Lead Sponsor	Collaborator
University of Oslo	Norwegian School of Sport Sciences, Oslo and Akershus University College of Applied Sciences, The Research Council of Norway, Tine

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Effect on PBMC whole genome transcriptomics	Measurement of PBMC Whole genome transcriptomics will be performed.	Measured at baseline and after 12 weeks (end-of-study visit)	No
Other	Changes in body composition (including bone mineral density)	Changes in body composition are measured by DXA.	Measured at baseline and after 12 weeks (end-of-study visit)	No
Other	Changes in the level of appetite regulatory hormones	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)	Measured at baseline and after 12 weeks (end-of-study visit)	No
Other	Changes in the Lymphocyte DNA damage and repair system	Changes will be measured using Whole blood and PBMC.	Measured at baseline and after 12 weeks (end-of-study visit)	No
Primary	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)	No
Secondary	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)	No