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Clinical Trials/NCT00826761
NCT00826761CompletedNot Applicable

Probiotics and Satiety - Acute Effects and Persistence of Acute Effects

University of Copenhagen1 site in 1 country22 target enrollmentStarted: January 1, 2009Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
22
Locations
1
Primary Endpoint
Glucose; Insulin; GLP-1; CCK; PYY; grehlin; PP; amylin; LPS; TNF-alfa; hsCRP; fibrinogen
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 45 Years (Adult)
Sex
All
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

  • •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

Arms & Interventions

3

Placebo Comparator

Intervention: placebo (Dietary Supplement)

1

Active Comparator

High dose Lb. casei

Intervention: probiotic (Dietary Supplement)

2

Active Comparator

Low dose Lb. Casei

Intervention: probiotic (Dietary Supplement)

Outcomes

Primary Outcomes

Glucose; Insulin; GLP-1; CCK; PYY; grehlin; PP; amylin; LPS; TNF-alfa; hsCRP; fibrinogen

Time Frame: 2013

Secondary Outcomes

  • Subjective appetite measurements; Spontaneous food intake(2012)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

AAstrup

Professor

University of Copenhagen

Study Sites (1)

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