Clinical trial NCT02218333: Health Effects of Milk Proteins in Elderly Subjects
Official title: Effect of Milk Proteins on Body Composition, Muscle Strength, Inflammation and Bone Health in Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
name: Tine
name: Oslo Metropolitan University
name: Norwegian School of Sport Sciences
First posted: 2014-08-18
Enrollment: 50
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in muscle mass, strength and performance
timeFrame: Measured at baseline and after 12 weeks (end-of-study visit)
Secondary outcomes:
measure: Changes in levels of inflammatory markers
timeFrame: Measured at baseline and after 12 weeks (end-of-study visit)
Other outcomes:
measure: Effect on PBMC whole genome transcriptomics
timeFrame: Measured at baseline and after 12 weeks (end-of-study visit)
measure: Changes in body composition (including bone mineral density)
timeFrame: Measured at baseline and after 12 weeks (end-of-study visit)
measure: Changes in the level of appetite regulatory hormones
timeFrame: Measured at baseline and after 12 weeks (end-of-study visit)
measure: Changes in the Lymphocyte DNA damage and repair system
timeFrame: Measured at baseline and after 12 weeks (end-of-study visit)
Locations:
city: Oslo
country: Norway
facility: University of Oslo
state: Post box 1046, Blindern
Study officials:
affiliation: Institute of Basic Medical Sciences, Faculty of medicine, University of Oslo
name: Kirsten Holven, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gjevestad GO, Holven KB, Rundblad A, Flatberg A, Myhrstad M, Karlsen K, Mutt SJ, Herzig KH, Ottestad I, Ulven SM. Increased protein intake affects pro-opiomelanocortin (POMC) processing, immune function and IGF signaling in peripheral blood mononuclear cells of home-dwelling old subjects using a genome-wide gene expression approach. Genes Nutr. 2019 Nov 28;14:32. doi: 10.1186/s12263-019-0654-6. eCollection 2019.
citation: Ottestad I, Lovstad AT, Gjevestad GO, Hamarsland H, Saltyte Benth J, Andersen LF, Bye A, Biong AS, Retterstol K, Iversen PO, Raastad T, Ulven SM, Holven KB. Intake of a Protein-Enriched Milk and Effects on Muscle Mass and Strength. A 12-Week Randomized Placebo Controlled Trial among Community-Dwelling Older Adults. J Nutr Health Aging. 2017;21(10):1160-1169. doi: 10.1007/s12603-016-0856-1.