NCT03821116

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2019

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 29, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

1.4 years

First QC Date

January 16, 2019

Last Update Submit

November 3, 2020

Conditions

Oxidative StressInflammation

Outcome Measures

Primary Outcomes (2)

  • Change in oxidative stress marker

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

    baseline and 3 weeks

  • Change in oxidative stress marker

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

    6 weeks and 9 weeks

Secondary Outcomes (6)

  • Change in interleukin-6 (IL-6)

    baseline and 3 weeks

  • Change in interleukin-6 (IL-6)

    6 weeks and 9 weeks

  • Change high sensitive C-reactive protein (hs-CRP)

    baseline and 3 weeks

  • Change high sensitive C-reactive protein (hs-CRP)

    6 weeks and 9 weeks

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

    baseline and 3 weeks

  • +1 more secondary outcomes

Study Arms (2)

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%.

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%.

Other: Soured milk (filmjölk)

Interventions

MilkOTHER

Swedish milk from cow.

Milk
Soured milk (filmjölk)OTHER

Swedish soured milk (from cow milk).

Soured milk (filmjölk)

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Forskningsmottagning bentäthet, Kirurgiska vetenskaper, Uppsala Universitet

Uppsala, 75185, Sweden

Location

Related Publications (4)

  • 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.

    PMID: 26378576BACKGROUND

  • 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.

    PMID: 25352269BACKGROUND

  • 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.

    PMID: 28490510BACKGROUND

  • 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.

    PMID: 26169198BACKGROUND

MeSH Terms

Conditions

Inflammation

Interventions

Milk

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • Liisa Byberg, PhD

    Department of Surgical Sciences, Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2019

First Posted

January 29, 2019

Study Start

January 7, 2019

Primary Completion

June 9, 2020

Study Completion

June 9, 2020

Last Updated

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)