NCT01240018

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2010

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 15, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Last Updated

June 15, 2012

Status Verified

June 1, 2012

Enrollment Period

1.7 years

First QC Date

June 25, 2010

Last Update Submit

June 14, 2012

Conditions

ObesityAppetite Regulation

Outcome Measures

Primary Outcomes (1)

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

    June 2011

Secondary Outcomes (1)

  • Subjective appetite measurements, spontaneous food intake.

    June 2011

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Probiotic

High dose Lb. casei

ACTIVE COMPARATOR
Dietary Supplement: Probiotic

Interventions

ProbioticDIETARY_SUPPLEMENT

Parallel, randomized, controlled 2 arms study.

High dose Lb. caseiPlacebo

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Copenhagen, Department of Human Nutrition

Frederiksberg, DK, 1958, Denmark

Location

MeSH Terms

Conditions

Obesity

Interventions

Probiotics

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Arne Astrup, MD

    Department of Human Nutrition, Copenhagen University, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 25, 2010

First Posted

November 15, 2010

Study Start

September 1, 2009

Primary Completion

June 1, 2011

Last Updated

June 15, 2012

Record last verified: 2012-06

Locations

DK(1)