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ProSat - Effect of Probiotics on Satiety (ProSat)

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ClinicalTrials.gov Identifier: NCT00826761
Recruitment Status : Completed
First Posted : January 22, 2009
Last Update Posted : June 15, 2012
Sponsor:
Collaborator:
Chr Hansen
Information provided by (Responsible Party):
AAstrup, University of Copenhagen

Tracking Information
First Submitted Date  ICMJE January 21, 2009
First Posted Date  ICMJE January 22, 2009
Last Update Posted Date June 15, 2012
Study Start Date  ICMJE January 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2012)
Glucose; Insulin; GLP-1; CCK; PYY; grehlin; PP; amylin; LPS; TNF-alfa; hsCRP; fibrinogen [ Time Frame: 2013 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 21, 2009)
Glucose; Insulin; GLP-1; CCK; PYY; grehlin; PP; amylin; LPS; TNF-alfa; hsCRP; fibrinogen
Change History Complete list of historical versions of study NCT00826761 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2012)
Subjective appetite measurements; Spontaneous food intake [ Time Frame: 2012 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2009)
Subjective appetite measurements; Spontaneous food intake
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ProSat - Effect of Probiotics on Satiety
Official Title  ICMJE Probiotics and Satiety - Acute Effects and Persistence of Acute Effects
Brief Summary The aim of the ProSat study is to examine the effects of a probiotic capsule containing one of two doses (low and high dose) of Lb. Casei on subjective appetite sensation, ad libitum energy intake, and appetite hormone response in a single meal test and to determine whether the acute effects persist after daily supplementation of the probiotic capsule.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Obesity
  • Appetite Regulation
Intervention  ICMJE
  • Dietary Supplement: probiotic
    One capsule per meal test (high dose or low dose)
  • Dietary Supplement: placebo
    1 capsuel every morning
Study Arms  ICMJE
  • Active Comparator: 1
    High dose Lb. casei
    Intervention: Dietary Supplement: probiotic
  • Active Comparator: 2
    Low dose Lb. Casei
    Intervention: Dietary Supplement: probiotic
  • Placebo Comparator: 3
    Intervention: Dietary Supplement: placebo
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 Completed
Actual Enrollment  ICMJE
 (submitted: January 21, 2009)
22
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy men and women
  • Normal to slight overweight (BMI: 22-28 kg/m2)
  • 20-45 years of age

Exclusion Criteria:

  • Smoking
  • Daily medicine use (oral contraceptives excluded)
  • Use of pre- and probiotic supplements and foods
  • Blood donation 3 months prior to the study
  • Hb<8mmol/l
  • Chronic illnesses such as hyperlipidemia, diabetes inflammatory diseases
  • Pregnancy or breastfeeding
  • Elite athletes (>10 hours hard exercise/week)
  • Vegetarians
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE 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 NCT00826761
Other Study ID Numbers  ICMJE B257
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AAstrup, University of Copenhagen
Study Sponsor  ICMJE University of Copenhagen
Collaborators  ICMJE Chr Hansen
Investigators  ICMJE Not Provided
PRS Account University of Copenhagen
Verification Date June 2012

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