Health Effects of Milk Proteins in Elderly Subjects

NCT ID: NCT02218333

Last Updated: 2015-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control drink

An isocaloric drink to milk

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Milk

Protein enriched milk (Styrk)

Group Type EXPERIMENTAL

Milk

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Milk

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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TINE Styrk milk Isocaloric drink

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Research Council of Norway

OTHER

Sponsor Role collaborator

Tine

INDUSTRY

Sponsor Role collaborator

Oslo Metropolitan University

OTHER

Sponsor Role collaborator

Norwegian School of Sport Sciences

OTHER

Sponsor Role collaborator

University of Oslo

OTHER

Sponsor Role lead

Responsible Party

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Kirsten Holven

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kirsten Holven, Professor

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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University of Oslo

Oslo, Post Box 1046, Blindern, Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 31798754 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29188875 (View on PubMed)

Other Identifiers

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2014/150/REK sør-øst C

Identifier Type: -

Identifier Source: org_study_id

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