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Effect of UHT Treated Milk on Blolipid Profile (UHT)

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ClinicalTrials.gov Identifier: NCT01753700
Recruitment Status : Unknown
Verified December 2012 by AAstrup, University of Copenhagen.
Recruitment status was:  Recruiting
First Posted : December 20, 2012
Last Update Posted : December 20, 2012
Sponsor:
Collaborators:
Arla Foods
Hoeng Fonden
Bionor Pharma
Information provided by (Responsible Party):
AAstrup, University of Copenhagen

Tracking Information
First Submitted Date  ICMJE December 17, 2012
First Posted Date  ICMJE December 20, 2012
Last Update Posted Date December 20, 2012
Study Start Date  ICMJE December 2012
Estimated Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2012)
Blood lipids [ Time Frame: 3 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of UHT Treated Milk on Blolipid Profile
Official Title  ICMJE Effect of UHT Treated Milk on Blolipid Profile
Brief Summary The studie are to investigate the effect of ultra heat treated (UHT) versus pasteurised milk on bloodlipid profile
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE To Investigate the Effect of UHT Treated Milk Versus Pasteurised Milk on Bloodlipid Profil
Intervention  ICMJE Dietary Supplement: UHT treated milk
Study Arms
  • Experimental: UHT treated milk
    1,5 L of 1,5% UHT milk pr day for 3 weeks (21days)
    Intervention: Dietary Supplement: UHT treated milk
  • Placebo Comparator: Paseurised milk
    1,5 L 1,5% pasteurised milk pr day for 3 weeks (21 days)
    Intervention: Dietary Supplement: UHT treated milk
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 17, 2012)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date March 2013
Estimated Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 22 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01753700
Other Study ID Numbers  ICMJE B300
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party AAstrup, University of Copenhagen
Study Sponsor  ICMJE University of Copenhagen
Collaborators  ICMJE
  • Arla Foods
  • Hoeng Fonden
  • Bionor Pharma
Investigators  ICMJE Not Provided
PRS Account University of Copenhagen
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP