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Oxidative StressNCT03821116

Milk and Soured Milk (filmjölk) Intervention on Oxidative Stress and Inflammation

A study testing Milk and Soured milk (filmjölk) in people with Oxidative Stress and Inflammation, run by Uppsala University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluates a high intake of milk compared with a high intake of soured milk (Swedish filmjölk) on markers of oxidative stress and inflammation in a randomized crossover intervention study. Read more about this study

Who is it for?
Ages 40 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Oxidative Stress, Inflammation
What is being tested?
Milk and Soured milk (filmjölk)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteSweden
Study dates
7 Jan 2019to 9 Jun 2020
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 40 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Tolerates both a low and a high intake of milk and soured milk
  • Agrees to comply with study protocol

Who cannot join

  • Inflammatory bowel disease
  • Major gastric tract operation
  • Pregnancy
  • Eating disorder

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Forskningsmottagning bentäthet, Kirurgiska vetenskaper, Uppsala Universitet

    Uppsala, 75185

Other trials in Sweden

About this study

Official title: Milk and Soured Milk (filmjölk) Intervention on Oxidative Stress and Inflammation: A Randomized Crossover Intervention Study

This study evaluates a high intake of milk compared with a high intake of soured milk (Swedish filmjölk) on markers of oxidative stress and inflammation in a randomized crossover intervention study.

Read the detailed description

A diet rich in antioxidants reduces oxidative stress and inflammation and could potentially improve health and lower the rate of hip fracture. Milk and dairy are also promoted as part of a healthy diet since they contain 18 of 22 essential nutrients including calcium, phosphorous, and vitamin D and have been suggested to be associated with lower risk of cardiovascular disease, especially stroke, type 2 diabetes, and cancer. Meta-analyses of milk and dairy on fracture and mortality risk in cohort studies are, however, inconclusive and show significant heterogeneity between studies. Small intakes may have beneficial effects in comparison to null intake whereas higher intakes may have other effects and non-linear relationships are rarely examined. Frequently, different milk products are considered as one entity in cohort studies. The investigators recently showed that different milk products might have differential effects on disease. A high long-term milk intake was associated with an increased risk of mortality (total, cardiovascular, and cancer mortality) and hip fracture, especially among women, whereas a high long-term intake of fermented milk (soured milk and yogurt or cheese) was associated with a lower risk of mortality and fracture among women. Similar results have been presented for total mortality (Northern Sweden) and humeral fractures (South-Eastern Australia).

Intake of milk and fermented milk is of tradition high in Sweden. The prevalence of lactase persistence is high (around 95%). The range in milk intake from non- and low-consumers to high consumers makes Sweden an appropriate setting for epidemiological and interventional studies.

A common potential mechanism for intake of fruits, vegetables, and different dairy products on risk of disease is their influence on inflammation and oxidative stress. Chronic low-grade inflammation and age-related increase of oxidative stress are suggested pathogenic mechanisms of premature ageing and many diseases including cardiovascular disease, cancer, accelerated bone loss (leading to osteoporosis), and age-related reduction of muscle strength and mass (sarcopenia) with potential impacts on risk of falling and fracture. The lower risk of fractures with a high intake of fermented milk products observed may be due to potential probiotic, antioxidative, and anti-inflammatory effects and effects on gut microbiota. A high intake of milk was not only associated with risk of mortality and fractures but also with increased concentrations of inflammation and oxidative stress markers. An inverse association was seen for intake of soured milk and yogurt [Michaëlsson, 2014]. Fermented milk products with probiotics have been shown to reduce the levels of inflammation markers, other studies have been small to show conclusive effects and results may also be dependent on the probiotic strain. A head-to-head comparison of the effect of regular milk and soured milk (or yogurt) on markers of inflammation and oxidative stress in a randomized intervention study is warranted. The randomized crossover intervention study will be performed among both men and women.

The aim of the study is to examine the potentially different short-term effects of milk and sour milk on markers of oxidative stress and inflammation in a randomized cross-over trial. The research questions are:

  1. In a randomized cross-over trial, what is the effect of a daily intake of at least 500 ml of Swedish milk compared with an intake of at least 500 ml Swedish soured milk (filmjölk) during 3 weeks on markers of oxidative stress and inflammation?
  2. What are the effects of these milk products on a large number of proteins related with inflammation and ageing diseases, assessed with large-scale proteomic analysis?
  3. What are the effects of these milk products on metabolites involved in inflammation and ageing diseases using large-scale metabolomics analysis?
  4. What are the effects of these milk products on the gut microflora (microbiome)?

Changes in proteomics, metabolomics and the gut microbiome are other pre-specified outcome measures but since they are exploratory in nature, we do not specify them under outcomes since it is not possible to exactly specify these outcome measures. Exploratory analyses will include whether effects are different between men and women, dependent on body composition (assessed with whole body dual X-ray absorptiometry, DXA) or long-term dietary intake (assessed by fatty acid composition in subcutaneous fat). Participants will be allowed to consume more than 500 ml of milk/filmjölk during the intervention periods and, if possible, a potential dose-response effect will be evaluated.

Being tested
Milk, Soured milk (filmjölk)
Medical subject headings
Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MilkOther

    Swedish milk from cow.

  • Soured milk (filmjölk)Other

    Swedish soured milk (from cow milk).

Study groups in NCT03821116
Study groupRoleWhat they receive
MilkExperimentalAt least 500 ml of Swedish milk daily for three weeks (crossover). Intervention and crossover preceded by 3 weeks with max 50 ml of milk or soured milk (filmjölk) daily. Fat content of milk and soured milk should be the same: 0.5%, 1.5% or 3%.
Receives: Other: Milk
Soured milk (filmjölk)ExperimentalAt least 500 ml of Swedish soured milk (filmjölk) daily for three weeks (crossover). Intervention and crossover preceded by 3 weeks with max 50 ml of milk or soured milk (filmjölk) daily. Fat content of milk and soured milk should be the same: 0.5%, 1.5% or 3%.
Receives: Other: Soured milk (filmjölk)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in oxidative stress marker

    urinary 8-iso-prostaglandin F2 alpha (8-iso-PGF2alpha)

    Measured: baseline and 3 weeks

  2. Change in oxidative stress marker

    urinary 8-iso-prostaglandin F2 alpha (8-iso-PGF2alpha)

    Measured: 6 weeks and 9 weeks

Secondary outcomes (6)
  1. Change in interleukin-6 (IL-6)

    Inflammation marker, measured in serum

    Measured: baseline and 3 weeks

  2. Change in interleukin-6 (IL-6)

    Inflammation marker, measured in serum

    Measured: 6 weeks and 9 weeks

  3. Change high sensitive C-reactive protein (hs-CRP)

    Inflammation marker, measured in serum

    Measured: baseline and 3 weeks

  4. Change high sensitive C-reactive protein (hs-CRP)

    Inflammation marker, measured in serum

    Measured: 6 weeks and 9 weeks

  5. Change in 15-keto-dihydro-prostaglandin F2 alpha (15-keto-dihydro-PGF2alpha)

    Inflammation marker, a major metabolite of prostaglandin F2alpha, measured in urine

    Measured: baseline and 3 weeks

  6. Change in 15-keto-dihydro-prostaglandin F2 alpha (15-keto-dihydro-PGF2alpha)

    Inflammation marker, a major metabolite of prostaglandin F2alpha, measured in urine

    Measured: 6 weeks and 9 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2019
  2. Study start7 Jan 2019
  3. Primary completion9 Jun 2020
  4. Study completion9 Jun 2020

Resources

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
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03821116
Sponsor's protocol ID
MILK: EPN-Uppsala dnr 2018-328
Status last verified
Nov 2020
First submitted
16 Jan 2019
Last updated
4 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Larsson SC, Crippa A, Orsini N, Wolk A, Michaelsson K. Milk Consumption and Mortality from All Causes, Cardiovascular Disease, and Cancer: A Systematic Review and Meta-Analysis. Nutrients. 2015 Sep 11;7(9):7749-63. doi: 10.3390/nu7095363.

    PubMed 26378576
  • Michaelsson K, Wolk A, Langenskiold S, Basu S, Warensjo Lemming E, Melhus H, Byberg L. Milk intake and risk of mortality and fractures in women and men: cohort studies. BMJ. 2014 Oct 28;349:g6015. doi: 10.1136/bmj.g6015.

    PubMed 25352269
  • Tognon G, Nilsson LM, Shungin D, Lissner L, Jansson JH, Renstrom F, Wennberg M, Winkvist A, Johansson I. Nonfermented milk and other dairy products: associations with all-cause mortality. Am J Clin Nutr. 2017 Jun;105(6):1502-1511. doi: 10.3945/ajcn.116.140798. Epub 2017 May 10.

    PubMed 28490510
  • Holloway KL, Bucki-Smith G, Morse AG, Brennan-Olsen SL, Kotowicz MA, Moloney DJ, Sanders KM, Korn S, Timney EN, Dobbins AG, Pasco JA. Humeral Fractures in South-Eastern Australia: Epidemiology and Risk Factors. Calcif Tissue Int. 2015 Nov;97(5):453-65. doi: 10.1007/s00223-015-0039-9. Epub 2015 Jul 14.

    PubMed 26169198

Questions about this trial

What is this clinical trial studying?

A study testing Milk and Soured milk (filmjölk) in people with Oxidative Stress and Inflammation, run by Uppsala University at 1 site in Sweden.

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 2 inclusion and 4 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 4 Nov 2020. 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 Sweden. 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. 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 oxidative stress marker (time frame: baseline and 3 weeks). The study lists 2 primary outcomes in all. 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 NCT03821116, which also lists 4 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 4 Nov 2020.

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