ProSat - 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: NCT00826761
• Other study ID #: B257
• Status: Completed
• Phase: N/A
• First received: January 21, 2009
• Last updated: June 14, 2012
• Start date: January 2009

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• 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<8mmol/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
One capsule per meal test (high dose or low dose)
• placebo
1 capsuel every morning

Locations

Country	Name	City	State
Denmark	Department of Human Nutrition	Frederiksberg

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Chr Hansen A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose; Insulin; GLP-1; CCK; PYY; grehlin; PP; amylin; LPS; TNF-alfa; hsCRP; fibrinogen		2013	No
Secondary	Subjective appetite measurements; Spontaneous food intake		2012	No