ProSat - Effect of Probiotics on Satiety | NCT00826761

Studies
ProSat - Effect of Probiotics on Satiety

NCT00826761

Sponsor

University of Copenhagen

Status

Completed

Last Update Posted

Jun 15, 2012Estimated

Enrollment

22Actual

Phase

Not Applicable

Conditions

Obesity
Appetite Regulation

Interventions

probiotic
placebo

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

Jan 2009

Primary Completion Date

Jun 2009Actual

Completion Date

Not provided

First Submitted Date

Jan 21, 2009

First Submission Date that Met QC Criteria

Jan 21, 2009

First Posted Date

Jan 22, 2009Estimated

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

Name	Class
Novonesis	INDUSTRY

Description Module

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

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

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	High dose Lb. casei	Dietary Supplement: probiotic
2	Active Comparator	Low dose Lb. Casei	Dietary Supplement: probiotic
3	Placebo Comparator		Dietary Supplement: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
probiotic	Dietary Supplement	One capsule per meal test (high dose or low dose)	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glucose; Insulin; GLP-1; CCK; PYY; grehlin; PP; amylin; LPS; TNF-alfa; hsCRP; fibrinogen		2013

Secondary Outcomes

Measure	Description	Time Frame
Subjective appetite measurements; Spontaneous food intake		2012

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<8mmol/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

All

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Human Nutrition		Frederiksberg			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