NCT02218333

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 18, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

October 19, 2015

Status Verified

October 1, 2015

Enrollment Period

1.1 years

First QC Date

August 11, 2014

Last Update Submit

October 15, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Change in muscle mass, strength and performance

    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 Outcomes (1)

  • Changes in levels of inflammatory markers

    Measured at baseline and after 12 weeks (end-of-study visit)

Other Outcomes (4)

  • Effect on PBMC whole genome transcriptomics

    Measured at baseline and after 12 weeks (end-of-study visit)

  • Changes in body composition (including bone mineral density)

    Measured at baseline and after 12 weeks (end-of-study visit)

  • Changes in the level of appetite regulatory hormones

    Measured at baseline and after 12 weeks (end-of-study visit)

  • +1 more other outcomes

Study Arms (2)

Control drink

PLACEBO COMPARATOR

An isocaloric drink to milk

Dietary Supplement: Placebo

Milk

EXPERIMENTAL

Protein enriched milk (Styrk)

Dietary Supplement: Milk

Interventions

MilkDIETARY_SUPPLEMENT

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

Also known as: TINE Styrk milk
Milk
PlaceboDIETARY_SUPPLEMENT
Also known as: Isocaloric drink
Control drink

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • 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
  • Disability preventing physical tests
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oslo

Oslo, Post Box 1046, Blindern, 0317, Norway

Location

Related Publications (2)

  • 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.

    PMID: 31798754DERIVED

  • 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.

    PMID: 29188875DERIVED

MeSH Terms

Interventions

Milk

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • Kirsten Holven, Professor

    Institute of Basic Medical Sciences, Faculty of medicine, University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 11, 2014

First Posted

August 18, 2014

Study Start

August 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

October 19, 2015

Record last verified: 2015-10

Locations

NO(1)