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

Obesity Clinical Trial

— MOFF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01317251
• Other study ID #: B281
• Status: Completed
• Phase: N/A
• First received: March 11, 2011
• Last updated: September 4, 2014
• Start date: March 2011
• Est. completion date: September 2012

Study information

• Verified date: March 2011
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Scientific Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy males

• BMI 20-28 mg/m2

Exclusion Criteria:

• Smoking

• Medicine use

• Dietary supplements

• Lactose intolerance, milk allergy

• Dislike of dairy products

• Excessive physical activity (> 10h/wk)

• Known chronic illnesses

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Dietary intervention (without dairy products)
Control diet without dairy products
• Dietary intervention (high milk content)
Diet with a high content of milk (~1200 mg Ca/d from milk)
• Dietary intervention (high cheese content)
Diet with a high content of cheese (~1200 mg Ca/d from cheese)

Locations

Country	Name	City	State
Denmark	Department of Human Nutrition, University of Copenhagen	Frederiksberg C

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fecal fat excretion	Total excretion of fecal fat (grams/day)avaraged over five days	During day 10-14 in each period	No
Secondary	Total, HDL and LDL cholesterol		Day 1 and 14 in each period	No
Secondary	Triglycerides		Day 1 and 14 in each period	No
Secondary	Appetite sensation		Assessed on day 1, 8 and 14 in each period	No