The Effects of Dairy Products on Energy Balance
MEPEB
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Jun 2010
Typical duration for not_applicable obesity
1 active site
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
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 8, 2010
CompletedFirst Posted
Study publicly available on registry
September 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedJune 11, 2014
June 1, 2014
2.3 years
September 8, 2010
June 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Fecal fat excretion
24 weeks
Body weight
24 weeks
body composition
24 weeks
Secondary Outcomes (11)
Resting energy expenditure
24 weeks
Blood pressure
24 weeks
Appetite regulation
24 weeks
Lipid profile
24 weeks
Intestinal micro flora
24 weeks
- +6 more secondary outcomes
Study Arms (2)
high calcium
EXPERIMENTALDietary intake of calcium \~ 1500 mg/ d, including \~1200 mg/d from dairy products
Low calcium
ACTIVE COMPARATORLow dietary intake of calcium, i.e. \~ \<600 mg/d, including 0-1 portion of dairy products
Interventions
High dietary intake of calcium from dairy products (\~1200 mg/d)
Eligibility Criteria
You may qualify if:
- men and women,
- medium overweight (body mass index 28-36 kg/m2),
- years old,
- low habitual calcium intake (\<800 mg/d)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Exercise, Nutrition and Sports, Faculty of Sciences, University of Copenhagen
Frederiksberg, 1958, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Human Nutrition
Study Record Dates
First Submitted
September 8, 2010
First Posted
September 13, 2010
Study Start
June 1, 2010
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
June 11, 2014
Record last verified: 2014-06