ProSat - Long Term Effect of Probiotics on Satiety

Obesity Clinical Trial

— ProSat  

Official title:

Probiotics and Satiety - Acute Effects and Persistence of Acute Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01240018
• Other study ID #: B257II
• Status: Completed
• Phase: N/A
• First received: June 25, 2010
• Last updated: June 14, 2012
• Start date: September 2009

Study information

• Verified date: June 2012
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Appetite Regulation
• Obesity

Intervention

Dietary Supplement:
• Probiotic
Parallel, randomized, controlled 2 arms study.

Locations

Country	Name	City	State
Denmark	University of Copenhagen, Department of Human Nutrition	Frederiksberg	DK

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose, insulin, GLP-1, GLP-2, CCK, PYY, PP, ghrelin, amylin, LPS, TNF-alfa, CRP, fibrinogen.		June 2011	No
Secondary	Subjective appetite measurements, spontaneous food intake.		June 2011	No