The Effects of Dairy Products on Energy Balance

Obesity Clinical Trial

— MEPEB  

Official title:

The Effects of Dairy Products on Energy Balance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01199835
• Other study ID #: B251
• Status: Completed
• Phase: N/A
• First received: September 8, 2010
• Last updated: June 10, 2014
• Start date: June 2010
• Est. completion date: October 2012

Study information

• Verified date: June 2014
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• High Calcium intake from dairy products
High dietary intake of calcium from dairy products (~1200 mg/d)

Locations

Country	Name	City	State
Denmark	Department of Exercise, Nutrition and Sports, Faculty of Sciences, University of Copenhagen	Frederiksberg

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	The Danish Dairy Research Foundation, Denmark, The Ministry of Science, Technology and Innovation, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fecal fat excretion		24 weeks	No
Primary	Body weight		24 weeks	No
Primary	body composition		24 weeks	No
Secondary	Resting energy expenditure		24 weeks	No
Secondary	Blood pressure		24 weeks	No
Secondary	Appetite regulation		24 weeks	No
Secondary	Lipid profile		24 weeks	No
Secondary	Intestinal micro flora		24 weeks	No
Secondary	Metabolomics in urine, feces and blood		24 week	No
Secondary	calcium excretion		24 weeks	No
Secondary	bone markers		24 weeks	No
Secondary	vitamin D status		24 weeks	No
Secondary	calcium status		24 weeks	No
Secondary	lipid metabolism		24 weeks	No