Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Health Effects of Milk Proteins in Elderly Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02218333
Recruitment Status : Completed
First Posted : August 18, 2014
Last Update Posted : October 19, 2015
Sponsor:
Collaborators:
The Research Council of Norway
Tine
Oslo and Akershus University College of Applied Sciences
Norwegian School of Sport Sciences
Information provided by (Responsible Party):
Kirsten Holven, 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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Milk Dietary Supplement: Placebo Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Casein

Arm Intervention/treatment
Placebo Comparator: Control drink
An isocaloric drink to milk
Dietary Supplement: Placebo
Other Name: Isocaloric drink

Experimental: Milk
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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)

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
Layout table for location information
Norway
University of Oslo
Oslo, Post box 1046, Blindern, Norway, 0317
Sponsors and Collaborators
University of Oslo
The Research Council of Norway
Tine
Oslo and Akershus University College of Applied Sciences
Norwegian School of Sport Sciences
Investigators
Layout table for investigator information
Principal Investigator: Kirsten Holven, Professor Institute of Basic Medical Sciences, Faculty of medicine, University of Oslo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Kirsten Holven, Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT02218333     History of Changes
Other Study ID Numbers: 2014/150/REK sør-øst C
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: October 19, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Layout table for MeSH terms
Caseins
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action