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

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ClinicalTrials.gov Identifier: NCT03821116
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : March 24, 2020
Sponsor:
Collaborator:
Forte
Information provided by (Responsible Party):
Uppsala University

Brief 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.

Condition or disease Intervention/treatment Phase
Oxidative Stress Inflammation Other: Milk Other: Soured milk (filmjölk) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 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
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
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%.
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%.
Other: Soured milk (filmjölk)
Swedish soured milk (from cow milk).




Primary Outcome Measures :
  1. Change in oxidative stress marker [ Time Frame: baseline and 3 weeks ]
    urinary 8-iso-prostaglandin F2 alpha (8-iso-PGF2alpha)

  2. Change in oxidative stress marker [ Time Frame: 6 weeks and 9 weeks ]
    urinary 8-iso-prostaglandin F2 alpha (8-iso-PGF2alpha)


Secondary Outcome Measures :
  1. Change in interleukin-6 (IL-6) [ Time Frame: baseline and 3 weeks ]
    Inflammation marker, measured in serum

  2. Change in interleukin-6 (IL-6) [ Time Frame: 6 weeks and 9 weeks ]
    Inflammation marker, measured in serum

  3. Change high sensitive C-reactive protein (hs-CRP) [ Time Frame: baseline and 3 weeks ]
    Inflammation marker, measured in serum

  4. Change high sensitive C-reactive protein (hs-CRP) [ Time Frame: 6 weeks and 9 weeks ]
    Inflammation marker, measured in serum

  5. 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

  6. 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



Information from the National Library of Medicine

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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
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Liisa Byberg, PhD + 46 70 167 9400 liisa.byberg@surgsci.uu.se
Contact: Erika Olsson +46 72 999 9344 milk@surgsci.uu.se

Locations
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Sweden
Forskningsmottagning bentäthet, Kirurgiska vetenskaper, Uppsala Universitet Recruiting
Uppsala, Sweden, 75185
Contact: Erika Olsson    +46 72 999 9344    milk@surgsci.uu.se   
Contact: Carina Fredriksson    +46 18 611 7196    carina.fredriksson@regionuppsala.se   
Principal Investigator: Liisa Byberg, PhD         
Sponsors and Collaborators
Uppsala University
Forte
Investigators
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Principal Investigator: Liisa Byberg, PhD Department of Surgical Sciences, Uppsala University
Publications:
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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: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes