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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014