HealthyNCT02218333
Health Effects of Milk Proteins in Elderly Subjects
A study testing Milk in people with Healthy, run by University of Oslo at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- ≥ 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)
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- Mini Nutritional Assessment (MNA®) score ≥ 17
- Mini-mental status (MMSE-NR) score: ≥ 24
- Willing to participate according to the protocol
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Milk, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MilkDietary supplement
Also called TINE Styrk milk
4 dl milk will be consumed daily with breakfast and supper for 12 weeks
PlaceboDietary supplement
Also called Isocaloric drink
| Study group | Role | What they receive |
|---|---|---|
| Control drink | Placebo comparator | An isocaloric drink to milk Receives: Dietary Supplement: Placebo |
| Milk | Experimental | Protein enriched milk (Styrk) Receives: Dietary Supplement: Milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at baseline and after 12 weeks (end-of-study visit)
Secondary outcomes (1)
Changes in levels of inflammatory markers
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: Measured at baseline and after 12 weeks (end-of-study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway, Tine, Oslo Metropolitan University, Norwegian School of Sport Sciences
- Responsible party
- Principal investigator, Kirsten Holven, University of Oslo
- Investigators
- Kirsten Holven, Professor, Principal investigator, Institute of Basic Medical Sciences, Faculty of medicine, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218333
- Sponsor's protocol ID
- 2014/150/REK sør-øst C
- Status last verified
- Oct 2015
- First submitted
- 11 Aug 2014
- Last updated
- 19 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31798754Ottestad 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.
PubMed 29188875
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Milk Proteins on Body Composition, Muscle Strength, Inflammation and Bone Health in Elderly Subjects
- ClinicalTrials.gov ID
- NCT02218333
- Acronym / sponsor ID
- 2014/150/REK sør-øst C
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- The Research Council of Norway, Tine, Oslo Metropolitan University, Norwegian School of Sport Sciences
- Study start
- Aug 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 18 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control drink | Placebo comparator | Dietary Supplement: PlaceboAn isocaloric drink to milk |
| Milk | Experimental | Dietary Supplement: MilkProtein enriched milk (Styrk) |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- ≥ 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MilkAlso: TINE Styrk milk4 dl milk will be consumed daily with breakfast and supper for 12 weeks | Dietary supplement | Milk |
| PlaceboAlso: Isocaloric drink | Dietary supplement | Control drink |
Primary outcome
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.
1 secondary outcome
Changes in levels of inflammatory markers
Time frame: Measured at baseline and after 12 weeks (end-of-study visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2015.
- Derived from this study: PubMed 31798754Gjevestad 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.
- Derived from this study: PubMed 29188875Ottestad 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten Holven, Professor principal investigator
Institute of Basic Medical Sciences, Faculty of medicine, University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk in people with Healthy, run by University of Oslo at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in muscle mass, strength and performance (time frame: Measured at baseline and after 12 weeks (end-of-study visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02218333, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2015.