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ProSat - Effect of Probiotics on Satiety

This study has been completed.
Sponsor:
Collaborator:
Chr Hansen A/S
Information provided by (Responsible Party):
AAstrup, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00826761
First received: January 21, 2009
Last updated: June 14, 2012
Last verified: June 2012
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Probiotics and Satiety - Acute Effects and Persistence of Acute Effects

Resource links provided by NLM:

U.S. FDA Resources

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 [ Time Frame: 2013 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective appetite measurements; Spontaneous food intake [ Time Frame: 2012 ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: January 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
High dose Lb. casei
 Dietary Supplement: probiotic
One capsule per meal test (high dose or low dose)
Active Comparator: 2
Low dose Lb. Casei
 Dietary Supplement: probiotic
One capsule per meal test (high dose or low dose)
Placebo Comparator: 3 Dietary Supplement: placebo
1 capsuel every morning

  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
Frederiksberg, Denmark
Sponsors and Collaborators
University of Copenhagen
Chr Hansen A/S
  More Information

No publications provided

Responsible Party: AAstrup, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT00826761     History of Changes
Other Study ID Numbers: B257
Study First Received: January 21, 2009
Last Updated: June 14, 2012
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013