ObesityProSatNCT00826761
ProSat - Effect of Probiotics on Satiety
A study testing probiotic in people with Obesity and Appetite Regulation, run by University of Copenhagen at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Appetite Regulation
- What is being tested?
- probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2009to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women
- Normal to slight overweight (BMI: 22-28 kg/m2)
- 20-45 years of age
Who cannot join
- Smoking
- 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
Show all 9Show fewer
- Pregnancy or breastfeeding
- Elite athletes (>10 hours hard exercise/week)
- Vegetarians
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Probiotics and Satiety - Acute Effects and Persistence of Acute Effects
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.
- Conditions
- Obesity, Appetite Regulation
- Being tested
- probiotic, placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probioticDietary supplement
One capsule per meal test (high dose or low dose)
placeboDietary supplement
1 capsuel every morning
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | High dose Lb. casei Receives: Dietary Supplement: probiotic |
| 2 | Active comparator | Low dose Lb. Casei Receives: Dietary Supplement: probiotic |
| 3 | Placebo comparator | Not described Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose; Insulin; GLP-1; CCK; PYY; grehlin; PP; amylin; LPS; TNF-alfa; hsCRP; fibrinogen
Measured: 2013
Secondary outcomes (1)
Subjective appetite measurements; Spontaneous food intake
Measured: 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Novonesis
- Responsible party
- Principal investigator, AAstrup, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826761
- Sponsor's protocol ID
- B257
- Acronym
- ProSat
- Status last verified
- Jun 2012
- First submitted
- 21 Jan 2009
- Last updated
- 15 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics and Satiety - Acute Effects and Persistence of Acute Effects
- ClinicalTrials.gov ID
- NCT00826761
- Acronym / sponsor ID
- ProSat / B257
- Conditions
- Obesity, Appetite Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Novonesis
- Study start
- Jan 2009
- Primary completion
- Jun 2009 (actual)
- First posted
- 22 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: probioticHigh dose Lb. casei |
| 2 | Active comparator | Dietary Supplement: probioticLow dose Lb. Casei |
| 3 | Placebo comparator | Dietary Supplement: placebo |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy men and women
- Normal to slight overweight (BMI: 22-28 kg/m2)
- 20-45 years of age
Key exclusion criteria (9 listed)
- Smoking
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| probioticOne capsule per meal test (high dose or low dose) | Dietary supplement | 1, 2 |
| placebo1 capsuel every morning | Dietary supplement | 3 |
Primary outcome
Glucose; Insulin; GLP-1; CCK; PYY; grehlin; PP; amylin; LPS; TNF-alfa; hsCRP; fibrinogen
Time frame: 2013
1 secondary outcome
Subjective appetite measurements; Spontaneous food intake
Time frame: 2012
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2012.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotic in people with Obesity and Appetite Regulation, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose; Insulin; GLP-1; CCK; PYY; grehlin; PP; amylin; LPS; TNF-alfa; hsCRP; fibrinogen (time frame: 2013). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2012.