ProSat - Long Term Effect of Probiotics on Satiety

Not Applicable

Completed

• Conditions: Obesity; Appetite Regulation
• Interventions: Dietary Supplement: Probiotic

• Registration Number: NCT01240018
• Lead Sponsor: University of Copenhagen

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 available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-06-25
• Study First Submitted QC: 2010-11-12
• Study First Posted: 2010-11-15
• Primary Completion: 2011-06
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-14
• Last Update Posted: 2012-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High dose Lb. casei	Probiotic	-
Placebo	Probiotic	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Subjective appetite measurements, spontaneous food intake.	June 2011

Trial Locations

Locations (1)

University of Copenhagen, Department of Human Nutrition; 🇩🇰 Frederiksberg, DK, Denmark