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Health Effects of Milk Proteins in Elderly Subjects

U

University of Oslo

Status

Completed

Conditions

Healthy

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Milk

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02218333
2014/150/REK sør-øst C

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

70+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

50 participants in 2 patient groups, including a placebo group

Control drink
Placebo Comparator group
Description:
An isocaloric drink to milk
Treatment:
Dietary Supplement: Placebo
Milk
Experimental group
Description:
Protein enriched milk (Styrk)
Treatment:
Dietary Supplement: Milk

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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