ProSat - Long Term Effect of Probiotics on Satiety | NCT01240018

Studies
ProSat - Long Term Effect of Probiotics on Satiety

NCT01240018

Sponsor

University of Copenhagen

Status

Completed

Last Update Posted

Jun 15, 2012Estimated

Enrollment

66Actual

Phase

Not Applicable

Conditions

Obesity
Appetite Regulation

Interventions

Probiotic

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Jun 2011Actual

Completion Date

Not provided

First Submitted Date

Jun 25, 2010

First Submission Date that Met QC Criteria

Nov 12, 2010

First Posted Date

Nov 15, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2012

Last Update Posted Date

Jun 15, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Dietary Supplement: Probiotic
High dose Lb. casei	Active Comparator		Dietary Supplement: Probiotic

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Probiotic	Dietary Supplement	Parallel, randomized, controlled 2 arms study.	High dose Lb. casei Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glucose, insulin, GLP-1, GLP-2, CCK, PYY, PP, ghrelin, amylin, LPS, TNF-alfa, CRP, fibrinogen.		June 2011

Secondary Outcomes

Measure	Description	Time Frame
Subjective appetite measurements, spontaneous food intake.		June 2011

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arne Astrup, MD	Department of Human Nutrition, Copenhagen University, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Copenhagen, Department of Human Nutrition		Frederiksberg	DK	1958	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019936	Probiotics

Ancestor Terms

ID	Term
D019587	Dietary Supplements
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided