ClinicalTrials.gg
CompletedNCT01317251MOFFUpdated Sep 5, 2014

Effect of Milk and Cheese on Fecal Fat Excretion and Blood Lipid

An interventional study of Dietary intervention (without dairy products) and Dietary intervention (high milk content) in Obesity, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-09-05.

Sponsored by University of Copenhagen · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study summary

The aim is to study the effect of milk versus cheese on fecal fat excretion and blood lipids. To do this, a randomized crossover intervention study with 3 14-day periods (control diet, milk diet, cheese diet) will be conducted in 16 young males. Fasting blood samples will be collected before and after each period, and fecal samples will be collected for the last 5 days in each period.

02

Conditions studied

  • Obesity

Keywords

  • Obesity prevention
  • appetite regulation
  • hyperlipidemia
03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's enrollment of 15 is below the median of 77 across 5,084 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University of Copenhagen is the lead sponsor of 465 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy males
  • BMI 20-28 mg/m2

Exclusion criteria

Exclusion Criteria:

  • Smoking
  • Medicine use
  • Dietary supplements
  • Lactose intolerance, milk allergy
  • Dislike of dairy products
  • Excessive physical activity (> 10h/wk)
  • Known chronic illnesses
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Control diet

    Diet without dairy products

    Other: Dietary intervention (without dairy products)

  • Experimental
    Milk diet

    Diet with a high content of milk

    Other: Dietary intervention (high milk content)

  • Experimental
    Cheese diet

    Diet with a high content of cheese

    Other: Dietary intervention (high cheese content)

Interventions

  • OtherDietary intervention (without dairy products)

    Control diet without dairy products

  • OtherDietary intervention (high milk content)

    Diet with a high content of milk (\~1200 mg Ca/d from milk)

  • OtherDietary intervention (high cheese content)

    Diet with a high content of cheese (\~1200 mg Ca/d from cheese)

06

What researchers measure

Primary outcomes

  1. Fecal fat excretion

    Total excretion of fecal fat (grams/day)avaraged over five days

    Time frame: During day 10-14 in each period

Secondary outcomes

  1. Total, HDL and LDL cholesterol

    Time frame: Day 1 and 14 in each period

  2. Triglycerides

    Time frame: Day 1 and 14 in each period

  3. Appetite sensation

    Time frame: Assessed on day 1, 8 and 14 in each period

07

Study locations

1 site
  • Department of Human Nutrition, University of Copenhagen
    Frederiksberg C, 1958, Denmark
08

References and documents

Publications

  • Soerensen KV, Thorning TK, Astrup A, Kristensen M, Lorenzen JK. Effect of dairy calcium from cheese and milk on fecal fat excretion, blood lipids, and appetite in young men. Am J Clin Nutr. 2014 May;99(5):984-91. doi: 10.3945/ajcn.113.077735. Epub 2014 Mar 12. PubMed 24622806 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2011, a primary completion of Apr 2012 and a completion of Sep 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 11, 2011
First posted
Mar 17, 2011
Start
Mar 2011
Primary completionActual
Apr 2012
CompletionActual
Sep 2012
Last update
Sep 5, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 5, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01317251
First posted
Mar 17, 2011
Start date
Mar 2011
Primary completion
Apr 2012
Completion
Sep 2012
Last update
Sep 5, 2014

Study contacts

Arne Astrup, Dr med
principal investigator · University of Copenhagen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.

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