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Completed

NCT Number: NCT02218333

Health Effects of Milk Proteins in Elderly Subjects

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.

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Key information

Conditions

Healthy

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oslo

Oslo, Post Box 1046, Blindern, 0317, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Milk

Dietary Supplement

4 dl milk will be consumed daily with breakfast and supper for 12 weeks

Other names: TINE Styrk milk

Placebo

Dietary Supplement

Other names: Isocaloric drink

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

  • Norwegian School of Sport Sciences
  • Oslo Metropolitan University
  • The Research Council of Norway
  • Tine

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 18, 2014
Registry last updated
Oct 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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