Health Effects of Milk Proteins in Elderly Subjects
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|ClinicalTrials.gov Identifier: NCT02218333|
Recruitment Status : Completed
First Posted : August 18, 2014
Last Update Posted : October 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Dietary Supplement: Milk Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Milk Proteins on Body Composition, Muscle Strength, Inflammation and Bone Health in Elderly Subjects|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
Placebo Comparator: Control drink
An isocaloric drink to milk
Dietary Supplement: Placebo
Other Name: Isocaloric drink
Protein enriched milk (Styrk)
Dietary Supplement: Milk
4 dl milk will be consumed daily with breakfast and supper for 12 weeks
Other Name: TINE Styrk milk
- Change in muscle mass, strength and performance [ Time Frame: 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.
- Changes in levels of inflammatory markers [ Time Frame: 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.
- Effect on PBMC whole genome transcriptomics [ Time Frame: Measured at baseline and after 12 weeks (end-of-study visit) ]Measurement of PBMC Whole genome transcriptomics will be performed.
- Changes in body composition (including bone mineral density) [ Time Frame: Measured at baseline and after 12 weeks (end-of-study visit) ]Changes in body composition are measured by DXA.
- Changes in the level of appetite regulatory hormones [ Time Frame: Measured at baseline and after 12 weeks (end-of-study visit) ]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)
- Changes in the Lymphocyte DNA damage and repair system [ Time Frame: Measured at baseline and after 12 weeks (end-of-study visit) ]Changes will be measured using Whole blood and PBMC.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02218333
|University of Oslo|
|Oslo, Post box 1046, Blindern, Norway, 0317|
|Principal Investigator:||Kirsten Holven, Professor||Institute of Basic Medical Sciences, Faculty of medicine, University of Oslo|