ProSat - Long Term Effect of Probiotics on Satiety

NCT ID: NCT01240018

Last Updated: 2012-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Appetite Regulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Probiotic

Intervention Type DIETARY_SUPPLEMENT

Parallel, randomized, controlled 2 arms study.

High dose Lb. casei

Group Type ACTIVE_COMPARATOR

Probiotic

Intervention Type DIETARY_SUPPLEMENT

Parallel, randomized, controlled 2 arms study.

Interventions

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Probiotic

Parallel, randomized, controlled 2 arms study.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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AAstrup

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arne Astrup, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Human Nutrition, Copenhagen University, Denmark

Locations

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University of Copenhagen, Department of Human Nutrition

Frederiksberg, DK, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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B257II

Identifier Type: -

Identifier Source: org_study_id

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