ProSat - Effect of Probiotics on Satiety

This study is currently recruiting participants.

Verified by University of Copenhagen, January 2009

First Received: January 21, 2009 No Changes Posted

Sponsors and Collaborators:	University of Copenhagen Chr Hansen A/S
Information provided by:	University of Copenhagen
ClinicalTrials.gov Identifier:	NCT00826761

Purpose

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.

Condition	Intervention
Obesity Appetite Regulation	Dietary Supplement: probiotic Dietary Supplement: placebo

MedlinePlus related topics: Dietary Supplements Diets Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment
Official Title:	Probiotics and Satiety - Acute Effects and Persistence of Acute Effects

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:

Glucose; Insulin; GLP-1; CCK; PYY; grehlin; PP; amylin; LPS; TNF-alfa; hsCRP; fibrinogen [ Designated as safety issue: No ]

Secondary Outcome Measures:

Subjective appetite measurements; Spontaneous food intake

Estimated Enrollment:	22
Study Start Date:	January 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator High dose Lb. casei	Dietary Supplement: probiotic One capsule per meal test (high dose or low dose)
2: Active Comparator Low dose Lb. Casei	Dietary Supplement: probiotic One capsule per meal test (high dose or low dose)
3: Placebo Comparator	Dietary Supplement: placebo

Eligibility

Ages Eligible for Study:	20 Years to 45 Years
Genders Eligible for Study:	Both
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<8mmol/l
Chronic illnesses such as hyperlipidemia, diabetes inflammatory diseases
Pregnancy or breastfeeding
Elite athletes (>10 hours hard exercise/week)
Vegetarians

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826761

Locations

Denmark
Department of Human Nutrition	Recruiting
Frederiksberg, Denmark
Contact: Arne Astrup, Dr. med 45-3533-2476
Contact: Anne Bjerg, MSc 45-3533-2191
Principal Investigator: Arne Astrup, Dr Med

Sponsors and Collaborators

University of Copenhagen

Chr Hansen A/S

More Information

No publications provided

Study ID Numbers:	B257
Study First Received:	January 21, 2009
Last Updated:	January 21, 2009
ClinicalTrials.gov Identifier:	NCT00826761 History of Changes
Health Authority:	Denmark: Ethics Committee

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on May 06, 2009