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ProSat - Long Term Effect of Probiotics on Satiety

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AAstrup, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01240018
First received: June 25, 2010
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 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

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, GLP-2, CCK, PYY, PP, ghrelin, amylin, LPS, TNF-alfa, CRP, fibrinogen. [ Time Frame: June 2011 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective appetite measurements, spontaneous food intake. [ Time Frame: June 2011 ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: September 2009
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Dietary Supplement: Probiotic
Parallel, randomized, controlled 2 arms study.
Active Comparator: High dose Lb. casei Dietary Supplement: Probiotic
Parallel, randomized, controlled 2 arms study.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Female
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 < 7,5mmol/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: NCT01240018

Locations
Denmark
University of Copenhagen, Department of Human Nutrition
Frederiksberg, DK, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Investigators
Principal Investigator: Arne Astrup, MD Department of Human Nutrition, Copenhagen University, Denmark
  More Information

No publications provided

Responsible Party: AAstrup, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01240018     History of Changes
Other Study ID Numbers: B257II
Study First Received: June 25, 2010
Last Updated: June 14, 2012
Health Authority: Denmark: Ethical Committee

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

ClinicalTrials.gov processed this record on May 16, 2013