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.
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
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:
- 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?
- 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?
- What are the effects of these milk products on metabolites involved in inflammation and ageing diseases using large-scale metabolomics analysis?
- 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.
- Conditions
- Oxidative Stress, Inflammation
- 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 group | Role | What they receive |
|---|---|---|
| Milk | Experimental | At 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) | Experimental | At 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.
Change in oxidative stress marker
urinary 8-iso-prostaglandin F2 alpha (8-iso-PGF2alpha)
Measured: baseline and 3 weeks
Change in oxidative stress marker
urinary 8-iso-prostaglandin F2 alpha (8-iso-PGF2alpha)
Measured: 6 weeks and 9 weeks
Secondary outcomes (6)
Change in interleukin-6 (IL-6)
Inflammation marker, measured in serum
Measured: baseline and 3 weeks
Change in interleukin-6 (IL-6)
Inflammation marker, measured in serum
Measured: 6 weeks and 9 weeks
Change high sensitive C-reactive protein (hs-CRP)
Inflammation marker, measured in serum
Measured: baseline and 3 weeks
Change high sensitive C-reactive protein (hs-CRP)
Inflammation marker, measured in serum
Measured: 6 weeks and 9 weeks
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
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.
- First posted29 Jan 2019
- Study start7 Jan 2019
- Primary completion9 Jun 2020
- Study completion9 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Forte
- Responsible party
- Sponsor
- Investigators
- Liisa Byberg, PhD, Principal investigator, Department of Surgical Sciences, Uppsala University
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 26378576Michaelsson 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 25352269Tognon 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 28490510Holloway 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Milk and Soured Milk (filmjölk) Intervention on Oxidative Stress and Inflammation: A Randomized Crossover Intervention Study
- ClinicalTrials.gov ID
- NCT03821116
- Acronym / sponsor ID
- MILK: EPN-Uppsala dnr 2018-328
- Conditions
- Oxidative Stress, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Forte
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 9 Jun 2020 (actual)
- Study completion
- 9 Jun 2020 (actual)
- First posted
- 29 Jan 2019 (actual)
- 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.
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.
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:
- 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?
- 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?
- What are the effects of these milk products on metabolites involved in inflammation and ageing diseases using large-scale metabolomics analysis?
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Milk | Experimental | Other: MilkAt 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%. |
| Soured milk (filmjölk) | Experimental | Other: Soured milk (filmjölk)At 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%. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Tolerates both a low and a high intake of milk and soured milk
- Agrees to comply with study protocol
Key exclusion criteria (4 listed)
- Inflammatory bowel disease
- Major gastric tract operation
- Pregnancy
- Eating disorder
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 |
|---|---|---|
| MilkSwedish milk from cow. | Other | Milk |
| Soured milk (filmjölk)Swedish soured milk (from cow milk). | Other | Soured milk (filmjölk) |
Primary outcome
Change in oxidative stress marker
Time frame: baseline and 3 weeks
urinary 8-iso-prostaglandin F2 alpha (8-iso-PGF2alpha)
Change in oxidative stress marker
Time frame: 6 weeks and 9 weeks
urinary 8-iso-prostaglandin F2 alpha (8-iso-PGF2alpha)
6 secondary outcomes
Change in interleukin-6 (IL-6)
Time frame: baseline and 3 weeks
Change in interleukin-6 (IL-6)
Time frame: 6 weeks and 9 weeks
Change high sensitive C-reactive protein (hs-CRP)
Time frame: baseline and 3 weeks
Change high sensitive C-reactive protein (hs-CRP)
Time frame: 6 weeks and 9 weeks
Change in 15-keto-dihydro-prostaglandin F2 alpha (15-keto-dihydro-PGF2alpha)
Time frame: baseline and 3 weeks
Change in 15-keto-dihydro-prostaglandin F2 alpha (15-keto-dihydro-PGF2alpha)
Time frame: 6 weeks and 9 weeks
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 4 Nov 2020.
- Background: PubMed 26378576Larsson 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.
- Background: PubMed 25352269Michaelsson 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.
- Background: PubMed 28490510Tognon 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.
- Background: PubMed 26169198Holloway 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.
- Individual participant dataSharing planned: No
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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.
Liisa Byberg, PhD principal investigator
Department of Surgical Sciences, Uppsala University
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 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.