ProSat - Effect of Probiotics on Satiety - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	January 21, 2009
Last Updated Date	January 21, 2009
Start Date ^†	January 2009
Current Primary Outcome Measures ^† (submitted: January 21, 2009)	Glucose; Insulin; GLP-1; CCK; PYY; grehlin; PP; amylin; LPS; TNF-alfa; hsCRP; fibrinogen [ Designated as safety issue: No ]
Original Primary Outcome Measures ^†	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^† (submitted: January 21, 2009)	Subjective appetite measurements; Spontaneous food intake
Original Secondary Outcome Measures ^†	Same as current

Descriptive Information
Brief Title ^†	ProSat - Effect of Probiotics on Satiety
Official Title ^†	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
Study Phase
Study Type ^†	Interventional
Study Design ^†	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment
Condition ^†	Obesity Appetite Regulation
Intervention ^†	Dietary Supplement: probiotic Dietary Supplement: placebo
Study Arms / Comparison Groups	Active Comparator: High dose Lb. casei Active Comparator: Low dose Lb. Casei
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Recruiting
Enrollment ^†	22
Completion Date
Estimated Primary Completion Date	June 2009 (final data collection date for primary outcome measure)
Eligibility 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<8mmol/l Chronic illnesses such as hyperlipidemia, diabetes inflammatory diseases Pregnancy or breastfeeding Elite athletes (>10 hours hard exercise/week) Vegetarians
Gender	Both
Ages	20 Years to 45 Years
Accepts Healthy Volunteers	Yes
Contacts ^††
Location Countries ^†	Denmark
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00826761
Responsible Party
Secondary IDs ^††
Study Sponsor ^†	University of Copenhagen
Collaborators ^††	Chr Hansen A/S
Investigators ^†
Information Provided By	University of Copenhagen
Verification Date	January 2009
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.