ProSat - Long Term Effect of Probiotics on Satiety

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AAstrup, University of Copenhagen

ClinicalTrials.gov Identifier:

NCT01240018

First received: June 25, 2010

Last updated: June 14, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 25, 2010

Last Updated Date

June 14, 2012

Start Date ^ICMJE

September 2009

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Glucose, insulin, GLP-1, GLP-2, CCK, PYY, PP, ghrelin, amylin, LPS, TNF-alfa, CRP, fibrinogen. [ Time Frame: June 2011 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01240018 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Subjective appetite measurements, spontaneous food intake. [ Time Frame: June 2011 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

ProSat - Long Term 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 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

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Obesity
Appetite Regulation

Intervention ^ICMJE

Dietary Supplement: Probiotic

Parallel, randomized, controlled 2 arms study.

Study Arm (s)

Placebo Comparator: Placebo
Intervention: Dietary Supplement: Probiotic
Active Comparator: High dose Lb. casei
Intervention: Dietary Supplement: Probiotic

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

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

June 2011 (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 < 7,5mmol/l
Chronic illnesses such as hyperlipidemia, diabetes inflammatory diseases
Pregnancy or breastfeeding
Elite athletes (>10 hours hard exercise/week)
Vegetarians

Gender

Female

Ages

20 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01240018

Other Study ID Numbers ^ICMJE

B257II

Has Data Monitoring Committee

Responsible Party

AAstrup, University of Copenhagen

Study Sponsor ^ICMJE

University of Copenhagen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Arne Astrup, MD

Department of Human Nutrition, Copenhagen University, Denmark

Information Provided By

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

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