Health Effects of Milk Proteins in Elderly Subjects

October 15, 2015 updated by: Kirsten Holven, University of Oslo

Effect of Milk Proteins on Body Composition, Muscle Strength, Inflammation and Bone Health 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Post box 1046, Blindern
      • Oslo, Post box 1046, Blindern, Norway, 0317
        • University of Oslo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control drink
An isocaloric drink to milk
Dietary supplement: Placebo
Other Names:
  • 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 Names:
  • TINE Styrk milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured at baseline and after 12 weeks (end-of-study visit)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured at baseline and after 12 weeks (end-of-study visit)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured at baseline and after 12 weeks (end-of-study visit)
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.
Measured at baseline and after 12 weeks (end-of-study visit)
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)
Measured at baseline and after 12 weeks (end-of-study visit)
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.
Measured at baseline and after 12 weeks (end-of-study visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oslo

Collaborators

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

Investigators

  • Principal Investigator: Kirsten Holven, Professor, Institute of Basic Medical Sciences, Faculty of medicine, University of Oslo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

August 11, 2014

First Submitted That Met QC Criteria

August 15, 2014

First Posted (Estimate)

August 18, 2014

Study Record Updates

Last Update Posted (Estimate)

October 19, 2015

Last Update Submitted That Met QC Criteria

October 15, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 2014/150/REK sør-øst C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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