The Effects of Dairy Products on Energy Balance (MEPEB)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of Copenhagen.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
The Ministry of Science, Technology and Innovation, Denmark
The Danish Dairy Research Foundation, Denmark
Information provided by (Responsible Party):
AAstrup, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01199835
First received: September 8, 2010
Last updated: February 24, 2012
Last verified: February 2012

September 8, 2010
February 24, 2012
June 2010
December 2012   (final data collection date for primary outcome measure)
  • Fecal fat excretion [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Body weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • body composition [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • baseline fat excretion in feces after freeze drying [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    after freeze drying
  • mid-time fat excretion in feces after freeze drying [ Time Frame: 12 week ] [ Designated as safety issue: No ]
    after freeze drying
  • end-time fat excretion in feces after freeze drying [ Time Frame: 24 week ] [ Designated as safety issue: No ]
    after freeze drying
  • baseline body composition (lean mass, fat mass and bone mass) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    dual energy x-ray absorptiometry (DEXA)
  • mid-time body composition (lean mass, fat mass and bone mass) [ Time Frame: 12 week ] [ Designated as safety issue: No ]
    DEXA
  • end-time body composition (lean mass, fat mass and bone mass) [ Time Frame: 24 week ] [ Designated as safety issue: No ]
    DEXA
Complete list of historical versions of study NCT01199835 on ClinicalTrials.gov Archive Site
  • Resting energy expenditure [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Appetite regulation [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Lipid profile [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Intestinal micro flora [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Metabolomics in urine, feces and blood [ Time Frame: 24 week ] [ Designated as safety issue: No ]
  • calcium excretion [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • bone markers [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • vitamin D status [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • calcium status [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • lipid metabolism [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • baseline resting energy expenditure (REE) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    by ventilated HOOD system
  • baseline blood pressure [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    after 10 min. resting period
  • baseline appetite regulation in 40 subjects after single standard meal [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    by visual analogue scale (VAS)
  • baseline lipid profile [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    in serum
  • baseline intestinal micro flora [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    in feces
  • end-time REE [ Time Frame: 24 week ] [ Designated as safety issue: No ]
    by ventilated HOOD system
  • blood pressure [ Time Frame: 2 week ] [ Designated as safety issue: No ]
    after 10 min. resting period
  • blood pressure [ Time Frame: 4 week ] [ Designated as safety issue: No ]
    after 10 min. resting period
  • blood pressure [ Time Frame: 8 week ] [ Designated as safety issue: No ]
    after 10 min. resting period
  • mid-time blood pressure [ Time Frame: 12 week ] [ Designated as safety issue: No ]
    after 10 min. resting period
  • blood pressure [ Time Frame: 16 week ] [ Designated as safety issue: No ]
    after 10 min. resting period
  • blood pressure [ Time Frame: 20 week ] [ Designated as safety issue: No ]
    after 10 min. resting period
  • end-time blood pressure [ Time Frame: 24 week ] [ Designated as safety issue: No ]
    after 10 min. resting period
  • end-time appetite regulation in 40 subjects after single standard meal [ Time Frame: 24 week ] [ Designated as safety issue: No ]
    by VAS
  • mid-time lipid profile [ Time Frame: 12 week ] [ Designated as safety issue: No ]
    in serum
  • end-time lipid profile [ Time Frame: 24 week ] [ Designated as safety issue: No ]
    in serum
  • mid-time intestinal micro flora [ Time Frame: 12 week ] [ Designated as safety issue: No ]
    in feces
  • end-time intestinal micro flora [ Time Frame: 24 week ] [ Designated as safety issue: No ]
    in feces
Not Provided
Not Provided
 
The Effects of Dairy Products on Energy Balance
The Effects of Dairy Products on Energy Balance

The aim of the study is to investigate the long time effects of high and low intake of dairy products on fecal fat excretion, weight loss, blood pressure, lipid profile, lipid oxidation and appetite regulation in moderately overweight men and women over 24 weeks.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Obesity
Other: High Calcium intake from dairy products
High dietary intake of calcium from dairy products (~1200 mg/d)
  • Experimental: high calcium
    Dietary intake of calcium ~ 1500 mg/ d, including ~1200 mg/d from dairy products
    Intervention: Other: High Calcium intake from dairy products
  • Active Comparator: Low calcium
    Low dietary intake of calcium, i.e. ~ <600 mg/d, including 0-1 portion of dairy products
    Intervention: Other: High Calcium intake from dairy products
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • men and women,
  • medium overweight (body mass index 28-36 kg/m2),
  • 18-60 years old,
  • low habitual calcium intake (<800 mg/d)

Exclusion Criteria:

  • milk allergy, infection diseases and diabetes,
  • intake of dietary supplements,
  • smoking,
  • pregnancy and/or breast feeding,
  • any medications known to affect the outcome measurements,
  • weigh reducing diet,
  • gastrointestinal diseases,
  • participation in other intervention studies
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01199835
B251
Not Provided
AAstrup, University of Copenhagen
University of Copenhagen
  • The Ministry of Science, Technology and Innovation, Denmark
  • The Danish Dairy Research Foundation, Denmark
Not Provided
University of Copenhagen
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP