Milk and Soured Milk (filmjölk) Intervention on Oxidative Stress and Inflammation
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ClinicalTrials.gov Identifier: NCT03821116 |
Recruitment Status :
Completed
First Posted : January 29, 2019
Last Update Posted : November 4, 2020
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Condition or disease | Intervention/treatment | Phase |
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Oxidative Stress Inflammation | Other: Milk Other: Soured milk (filmjölk) | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 84 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Milk and Soured Milk (filmjölk) Intervention on Oxidative Stress and Inflammation: A Randomized Crossover Intervention Study |
Actual Study Start Date : | January 7, 2019 |
Actual Primary Completion Date : | June 9, 2020 |
Actual Study Completion Date : | June 9, 2020 |
Arm | Intervention/treatment |
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Experimental: Milk
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%.
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Other: Milk
Swedish milk from cow. |
Experimental: 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%.
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Other: Soured milk (filmjölk)
Swedish soured milk (from cow milk). |
- 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)
- Change in interleukin-6 (IL-6) [ Time Frame: baseline and 3 weeks ]Inflammation marker, measured in serum
- Change in interleukin-6 (IL-6) [ Time Frame: 6 weeks and 9 weeks ]Inflammation marker, measured in serum
- Change high sensitive C-reactive protein (hs-CRP) [ Time Frame: baseline and 3 weeks ]Inflammation marker, measured in serum
- Change high sensitive C-reactive protein (hs-CRP) [ Time Frame: 6 weeks and 9 weeks ]Inflammation marker, measured in serum
- Change in 15-keto-dihydro-prostaglandin F2 alpha (15-keto-dihydro-PGF2alpha) [ Time Frame: baseline and 3 weeks ]Inflammation marker, a major metabolite of prostaglandin F2alpha, measured in urine
- Change in 15-keto-dihydro-prostaglandin F2 alpha (15-keto-dihydro-PGF2alpha) [ Time Frame: 6 weeks and 9 weeks ]Inflammation marker, a major metabolite of prostaglandin F2alpha, measured in urine

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Ages Eligible for Study: | 40 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Tolerates both a low and a high intake of milk and soured milk
- Agrees to comply with study protocol
Exclusion Criteria:
- Inflammatory bowel disease
- Major gastric tract operation
- Pregnancy
- Eating disorder

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821116
Sweden | |
Forskningsmottagning bentäthet, Kirurgiska vetenskaper, Uppsala Universitet | |
Uppsala, Sweden, 75185 |
Principal Investigator: | Liisa Byberg, PhD | Department of Surgical Sciences, Uppsala University |
Responsible Party: | Uppsala University |
ClinicalTrials.gov Identifier: | NCT03821116 |
Other Study ID Numbers: |
MILK: EPN-Uppsala dnr 2018-328 |
First Posted: | January 29, 2019 Key Record Dates |
Last Update Posted: | November 4, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Inflammation Pathologic Processes |