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The Effects of Dairy Products on Energy Balance (MEPEB)

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ClinicalTrials.gov Identifier: NCT01199835
Recruitment Status : Completed
First Posted : September 13, 2010
Last Update Posted : June 11, 2014
Sponsor:
Collaborators:
The Ministry of Science, Technology and Innovation, Denmark
The Danish Dairy Research Foundation, Denmark
Information provided by (Responsible Party):
Arne Astrup, University of Copenhagen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Other: High Calcium intake from dairy products Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effects of Dairy Products on Energy Balance
Study Start Date : June 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium
U.S. FDA Resources

Arm Intervention/treatment
Experimental: high calcium
Dietary intake of calcium ~ 1500 mg/ d, including ~1200 mg/d from dairy products
Other: High Calcium intake from dairy products
High dietary intake of calcium from dairy products (~1200 mg/d)
Active Comparator: Low calcium
Low dietary intake of calcium, i.e. ~ <600 mg/d, including 0-1 portion of dairy products
Other: High Calcium intake from dairy products
High dietary intake of calcium from dairy products (~1200 mg/d)



Primary Outcome Measures :
  1. Fecal fat excretion [ Time Frame: 24 weeks ]
  2. Body weight [ Time Frame: 24 weeks ]
  3. body composition [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Resting energy expenditure [ Time Frame: 24 weeks ]
  2. Blood pressure [ Time Frame: 24 weeks ]
  3. Appetite regulation [ Time Frame: 24 weeks ]
  4. Lipid profile [ Time Frame: 24 weeks ]
  5. Intestinal micro flora [ Time Frame: 24 weeks ]
  6. Metabolomics in urine, feces and blood [ Time Frame: 24 week ]
  7. calcium excretion [ Time Frame: 24 weeks ]
  8. bone markers [ Time Frame: 24 weeks ]
  9. vitamin D status [ Time Frame: 24 weeks ]
  10. calcium status [ Time Frame: 24 weeks ]
  11. lipid metabolism [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT01199835


Locations
Denmark
Department of Exercise, Nutrition and Sports, Faculty of Sciences, University of Copenhagen
Frederiksberg, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
The Ministry of Science, Technology and Innovation, Denmark
The Danish Dairy Research Foundation, Denmark

Responsible Party: Arne Astrup, Department of Human Nutrition, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01199835     History of Changes
Other Study ID Numbers: B251
First Posted: September 13, 2010    Key Record Dates
Last Update Posted: June 11, 2014
Last Verified: June 2014

Keywords provided by Arne Astrup, University of Copenhagen:
obesity
metabolic syndrome
fecal fat excretion
fecal calcium
weight loss
appetite regulation
intestinal micro flora
lipid profile
energy balance

Additional relevant MeSH terms:
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs