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Effect of UHT Treated Milk on Blolipid Profile

This study is currently recruiting participants.
Verified December 2012 by University of Copenhagen
Sponsor:
Collaborators:
Arla Foods
Hoeng Fonden
Bionor Pharma
Information provided by (Responsible Party):
AAstrup, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01753700
First received: December 17, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

The studie are to investigate the effect of ultra heat treated (UHT) versus pasteurised milk on bloodlipid profile


Condition Intervention
To Investigate the Effect of UHT Treated Milk Versus Pasteurised Milk on Bloodlipid Profil
 Dietary Supplement: UHT treated milk

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of UHT Treated Milk on Blolipid Profile

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Blood lipids [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: UHT treated milk
1,5 L of 1,5% UHT milk pr day for 3 weeks (21days)
 Dietary Supplement: UHT treated milk
Placebo Comparator: Paseurised milk
1,5 L 1,5% pasteurised milk pr day for 3 weeks (21 days)
 Dietary Supplement: UHT treated milk

  Eligibility

Ages Eligible for Study:   22 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy men and women
  • 22-50 years of age
  • BMI 25-30
  • non smokers

Exclusion Criteria:

  • lactose intolerance
  • milk allergy or other types of food allergy
  • Intestinal, abdominal or endocrinnologic diseases
  • daily use of dietary supplements incl. vitamins and minerals
  • cronic diseases (diabetes, CVD etc.)
  • user of medicin on perscription that can influence the resuts of the study
  • allergic to paraamino benzoe acid
  • Physical activity > 10 h pr week
  • Blood donor
  • on a diet or change of dietary habits within 3 months
  • body weigh change > 3 kg within the last 3 month
  • special diets
  • concomitant participation on other studies
  • not able to comply with protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753700

Locations
Denmark
Department of Nutrition, Exercise and Sports Recruiting
Copenhagen, Frederiksberg, Denmark, 1958
Contact: Janne Lorenzen, Ass.Prof.     25324572 ext +45     jakh@ife.ku.dk    
Contact: Karina Sorensen, Msc     51680399 ext +45     karvs@ife.ku.dk    
Principal Investigator: Janne K Lorenzen, Ass. Proff.            
Sponsors and Collaborators
University of Copenhagen
Arla Foods
Hoeng Fonden
Bionor Pharma
  More Information

No publications provided

Responsible Party: AAstrup, MD, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01753700     History of Changes
Other Study ID Numbers: B300
Study First Received: December 17, 2012
Last Updated: December 17, 2012
Health Authority: Denmark: The Ethical Comitee of Copenhagen

Keywords provided by University of Copenhagen:
crossover
UHT milk
Pasteurised milk
supplement

ClinicalTrials.gov processed this record on May 22, 2013