The Effects of Dairy Products on Energy Balance | NCT01199835

Studies
The Effects of Dairy Products on Energy Balance

NCT01199835

Sponsor

University of Copenhagen

Status

Completed

Last Update Posted

Jun 11, 2014Estimated

Enrollment

80Actual

Phase

Not Applicable

Conditions

Obesity

Interventions

High Calcium intake from dairy products

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Oct 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Sep 8, 2010

First Submission Date that Met QC Criteria

Sep 10, 2010

First Posted Date

Sep 13, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2014

Last Update Posted Date

Jun 11, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Arne Astrup, Department of Human Nutrition, University of CopenhagenPrincipal Investigator

Lead Sponsor

University of CopenhagenOTHER

Collaborators

Name	Class
The Ministry of Science, Technology and Innovation, Denmark	OTHER_GOV
The Danish Dairy Research Foundation, Denmark	OTHER

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High Calcium intake from dairy products	Other	High dietary intake of calcium from dairy products (~1200 mg/d)	Low calcium high calcium

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fecal fat excretion		24 weeks
Body weight		24 weeks
body composition		24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Resting energy expenditure		24 weeks
Blood pressure		24 weeks
Appetite regulation

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Exercise, Nutrition and Sports, Faculty of Sciences, University of Copenhagen		Frederiksberg		1958	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D024821	Metabolic Syndrome
D015431	Weight Loss

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided