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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00826761
Other study ID # B257
Secondary ID
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. completion date
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


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
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