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CompletedNCT01240018ProSatUpdated Jun 15, 2012

ProSat - Long Term Effect of Probiotics on Satiety

An interventional study of Probiotic in Obesity and Appetite Regulation, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to female participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-06-15.

Sponsored by University of Copenhagen · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Obesity
  • Appetite Regulation
03

In context

Lead sponsor

University of Copenhagen is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy men and women
  • Normal to slight overweight (BMI: 22-28 kg/m2)
  • 20-45 years of age

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
66 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Dietary Supplement: Probiotic

  • Active comparator
    High dose Lb. casei

    Dietary Supplement: Probiotic

Interventions

  • Dietary supplementProbiotic

    Parallel, randomized, controlled 2 arms study.

06

What researchers measure

Primary outcomes

  1. Glucose, insulin, GLP-1, GLP-2, CCK, PYY, PP, ghrelin, amylin, LPS, TNF-alfa, CRP, fibrinogen.

    Time frame: June 2011

Secondary outcomes

  1. Subjective appetite measurements, spontaneous food intake.

    Time frame: June 2011

07

Study locations

1 site
  • University of Copenhagen, Department of Human Nutrition
    Frederiksberg, DK 1958, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01240018
Lead sponsor
University of Copenhagen
Responsible party
AAstrup (Professor, University of Copenhagen) — Principal investigator
First posted
Nov 15, 2010
Start date
Sep 2009
Primary completion
Jun 2011
Last update
Jun 15, 2012

Study contacts

Arne Astrup, MD
principal investigator · Department of Human Nutrition, Copenhagen University, Denmark

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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