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ProSat - Long Term Effect of Probiotics on Satiety (ProSat)

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ClinicalTrials.gov Identifier: NCT01240018
Recruitment Status : Completed
First Posted : November 15, 2010
Last Update Posted : June 15, 2012
Sponsor:
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 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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 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 : September 2009
Actual Primary Completion Date : June 2011

Arm Intervention/treatment
Placebo Comparator: Placebo Dietary Supplement: Probiotic
Parallel, randomized, controlled 2 arms study.
Active Comparator: High dose Lb. casei Dietary Supplement: Probiotic
Parallel, randomized, controlled 2 arms study.



Primary Outcome Measures :
  1. Glucose, insulin, GLP-1, GLP-2, CCK, PYY, PP, ghrelin, amylin, LPS, TNF-alfa, CRP, fibrinogen. [ Time Frame: June 2011 ]

Secondary Outcome Measures :
  1. Subjective appetite measurements, spontaneous food intake. [ Time Frame: June 2011 ]


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

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 < 7,5mmol/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 ClinicalTrials.gov identifier (NCT number): NCT01240018


Locations
Denmark
University of Copenhagen, Department of Human Nutrition
Frederiksberg, DK, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Investigators
Principal Investigator: Arne Astrup, MD Department of Human Nutrition, Copenhagen University, Denmark

Responsible Party: AAstrup, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01240018     History of Changes
Other Study ID Numbers: B257II
First Posted: November 15, 2010    Key Record Dates
Last Update Posted: June 15, 2012
Last Verified: June 2012