NCT01317251

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2011

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

September 5, 2014

Status Verified

March 1, 2011

Enrollment Period

1.1 years

First QC Date

March 11, 2011

Last Update Submit

September 4, 2014

Conditions

Obesity

Keywords

Obesity preventionappetite regulationhyperlipidemia

Outcome Measures

Primary Outcomes (1)

  • Fecal fat excretion

    Total excretion of fecal fat (grams/day)avaraged over five days

    During day 10-14 in each period

Secondary Outcomes (3)

  • Total, HDL and LDL cholesterol

    Day 1 and 14 in each period

  • Triglycerides

    Day 1 and 14 in each period

  • Appetite sensation

    Assessed on day 1, 8 and 14 in each period

Study Arms (3)

Control diet

EXPERIMENTAL

Diet without dairy products

Other: Dietary intervention (without dairy products)

Milk diet

EXPERIMENTAL

Diet with a high content of milk

Other: Dietary intervention (high milk content)

Cheese diet

EXPERIMENTAL

Diet with a high content of cheese

Other: Dietary intervention (high cheese content)

Interventions

Dietary intervention (without dairy products)OTHER

Control diet without dairy products

Control diet
Dietary intervention (high milk content)OTHER

Diet with a high content of milk (\~1200 mg Ca/d from milk)

Milk diet
Dietary intervention (high cheese content)OTHER

Diet with a high content of cheese (\~1200 mg Ca/d from cheese)

Cheese diet

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males
  • BMI 20-28 mg/m2

You may not qualify if:

  • Smoking
  • Medicine use
  • Dietary supplements
  • Lactose intolerance, milk allergy
  • Dislike of dairy products
  • Excessive physical activity (\> 10h/wk)
  • Known chronic illnesses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Human Nutrition, University of Copenhagen

Frederiksberg C, 1958, Denmark

Location

Related Publications (1)

  • Soerensen KV, Thorning TK, Astrup A, Kristensen M, Lorenzen JK. Effect of dairy calcium from cheese and milk on fecal fat excretion, blood lipids, and appetite in young men. Am J Clin Nutr. 2014 May;99(5):984-91. doi: 10.3945/ajcn.113.077735. Epub 2014 Mar 12.

    PMID: 24622806DERIVED

MeSH Terms

Conditions

ObesityHyperlipidemias

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDyslipidemiasLipid Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Arne Astrup, Dr med

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 11, 2011

First Posted

March 17, 2011

Study Start

March 1, 2011

Primary Completion

April 1, 2012

Study Completion

September 1, 2012

Last Updated

September 5, 2014

Record last verified: 2011-03

Locations

DK(1)