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ProSat - Effect of Probiotics on Satiety (ProSat)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00826761
Recruitment Status : Completed
First Posted : January 22, 2009
Last Update Posted : June 15, 2012
Chr Hansen
Information provided by (Responsible Party):
AAstrup, University of Copenhagen

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.

Condition or disease Intervention/treatment Phase
Obesity Appetite Regulation Dietary Supplement: probiotic Dietary Supplement: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Probiotics and Satiety - Acute Effects and Persistence of Acute Effects
Study Start Date : January 2009
Actual Primary Completion Date : June 2009

Arm Intervention/treatment
Active Comparator: 1
High dose Lb. casei
Dietary Supplement: probiotic
One capsule per meal test (high dose or low dose)

Active Comparator: 2
Low dose Lb. Casei
Dietary Supplement: probiotic
One capsule per meal test (high dose or low dose)

Placebo Comparator: 3 Dietary Supplement: placebo
1 capsuel every morning

Primary Outcome Measures :
  1. Glucose; Insulin; GLP-1; CCK; PYY; grehlin; PP; amylin; LPS; TNF-alfa; hsCRP; fibrinogen [ Time Frame: 2013 ]

Secondary Outcome Measures :
  1. Subjective appetite measurements; Spontaneous food intake [ Time Frame: 2012 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00826761

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Department of Human Nutrition
Frederiksberg, Denmark
Sponsors and Collaborators
University of Copenhagen
Chr Hansen
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Responsible Party: AAstrup, Professor, University of Copenhagen Identifier: NCT00826761    
Other Study ID Numbers: B257
First Posted: January 22, 2009    Key Record Dates
Last Update Posted: June 15, 2012
Last Verified: June 2012