ObesityNCT01433120
Targeting the Gut Microbiome to Investigate the Pathways of Progression From Obesity to Metabolic Diseases in an At-risk Population.
A study testing Lactobacillus paracasei ssp paracasei F19 and Flax seed fibres in people with Obesity and Insulin Resistance, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Studies of the human gut microbiome have suggested that treatment or prevention aimed at the obese microbiome could influence the development of obesity-associated metabolic disturbances. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Insulin Resistance
- What is being tested?
- Lactobacillus paracasei ssp paracasei F19 and Flax seed fibres
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2011to Aug 2013
- 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 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Post-menopausal
- BMI between 30-45 kg/m2
- Waist circumference > 80 cm
- High leukocyte count
Who cannot join
- Medically-treated Type 2 diabetes or dyslipidaemia
- Use of antibiotics during the last 3 months
- Use of pro- or prebiotic supplements during the last 6 weeks
- Illnesses related to the gastro-intestinal tract
- History of psychiatric diseases (incl. depression)
- Liver disease
- Alcohol abuse
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
Frederiksberg C, 1958
About this study
Studies of the human gut microbiome have suggested that treatment or prevention aimed at the obese microbiome could influence the development of obesity-associated metabolic disturbances.
The objective of this project is to explore if a dietary intervention in 60 obese women with the probiotic Lactobacillus paracasei ssp paracasei F19 or flax seed fibres targeting the gut microbiome, can reduce insulin resistance, low-grade inflammation or dyslipidaemia, and to explore the interaction between the human genome and the gut microbiome.
Read more
The study is based on the following hypotheses:
- Treatment with the probiotic Lactobacillus paracasei ssp paracasei F19 and flax seed fibres will lower the metabolic risk profile in the intervention groups compared with placebo.
- The effect on the metabolic risk markers can be correlated with changes in the gut microbiota (measured in faeces).
After completion of the dietary intervention, the participants are offered a 10-week weight reduction program. Those who participate in the weight-loss program are invited to an optional follow-up visit in connection with the last visit at the clinical dietician, for the purpose of exploring the effect of weight loss on the gut microbiota and obesity-associated metabolic disturbances.
- Conditions
- Obesity, Insulin Resistance
- Being tested
- Lactobacillus paracasei ssp paracasei F19, Flax seed fibres, Maltodextrin (Placebo)
- Keywords
- Obesity, Insulin resistance, Microbiota, Probiotic, Prebiotic
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus paracasei ssp paracasei F19Dietary supplement
10^10 CFU of Lactobacillus paracasei F19 (dissolved in a glass of water once per day)
Flax seed fibresDietary supplement
10 grams of flax seed fibres per day (baked into two breakfast buns)
Maltodextrin (Placebo)Dietary supplement
Maltodextrin is dissolved in a glas of water once per day
| Study group | Role | What they receive |
|---|---|---|
| Probiotic L. casei F19 | Experimental | Not described Receives: Dietary Supplement: Lactobacillus paracasei ssp paracasei F19 |
| Flax seed fibres | Experimental | Not described Receives: Dietary Supplement: Flax seed fibres |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Maltodextrin (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin resistance
3H OGTT (75g glucose)
Measured: Week 0,6
Changes in the gut microbiota
Measured: Week 0,6
Secondary outcomes (3)
Inflammatory markers
Measured: Week 0,4,6
Lipid metabolism
Measured: Week 0,6
Total fat mass and abdominal fat
Measured: Week 0,6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionJun 2012
- Study completionAug 2013
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck Foundation, Arla Foods
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
- Investigators
- Arne Astrup, MD, Professor, Principal investigator, Department of Human Nutrition, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433120
- Sponsor's protocol ID
- B-244 LuCamp
- Status last verified
- Jun 2014
- First submitted
- 9 Sep 2011
- Last updated
- 11 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting the Gut Microbiome to Investigate the Pathways of Progression From Obesity to Metabolic Diseases in an At-risk Population.
- ClinicalTrials.gov ID
- NCT01433120
- Acronym / sponsor ID
- B-244 LuCamp
- Conditions
- Obesity, Insulin Resistance
- Keywords
- Obesity, Insulin resistance, Microbiota, Probiotic, Prebiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Lundbeck Foundation, Arla Foods
- Study start
- Sep 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 13 Sep 2011 (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.
Studies of the human gut microbiome have suggested that treatment or prevention aimed at the obese microbiome could influence the development of obesity-associated metabolic disturbances.
The objective of this project is to explore if a dietary intervention in 60 obese women with the probiotic Lactobacillus paracasei ssp paracasei F19 or flax seed fibres targeting the gut microbiome, can reduce insulin resistance, low-grade inflammation or dyslipidaemia, and to explore the interaction between the human genome and the gut microbiome.
The study is based on the following hypotheses:
- Treatment with the probiotic Lactobacillus paracasei ssp paracasei F19 and flax seed fibres will lower the metabolic risk profile in the intervention groups compared with placebo.
- The effect on the metabolic risk markers can be correlated with changes in the gut microbiota (measured in faeces).
After completion of the dietary intervention, the participants are offered a 10-week weight reduction program. Those who participate in the weight-loss program are invited to an optional follow-up visit in connection with the last visit at the clinical dietician, for the purpose of exploring the effect of weight loss on the gut microbiota and obesity-associated metabolic disturbances.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotic L. casei F19 | Experimental | Dietary Supplement: Lactobacillus paracasei ssp paracasei F19 |
| Flax seed fibres | Experimental | Dietary Supplement: Flax seed fibres |
| Placebo | Placebo comparator | Dietary Supplement: Maltodextrin (Placebo) |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Post-menopausal
- BMI between 30-45 kg/m2
- Waist circumference > 80 cm
- High leukocyte count
Key exclusion criteria (7 listed)
- Medically-treated Type 2 diabetes or dyslipidaemia
- Use of antibiotics during the last 3 months
- Use of pro- or prebiotic supplements during the last 6 weeks
- Illnesses related to the gastro-intestinal tract
- History of psychiatric diseases (incl. depression)
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 |
|---|---|---|
| Lactobacillus paracasei ssp paracasei F1910^10 CFU of Lactobacillus paracasei F19 (dissolved in a glass of water once per day) | Dietary supplement | Probiotic L. casei F19 |
| Flax seed fibres10 grams of flax seed fibres per day (baked into two breakfast buns) | Dietary supplement | Flax seed fibres |
| Maltodextrin (Placebo)Maltodextrin is dissolved in a glas of water once per day | Dietary supplement | Placebo |
Primary outcome
Insulin resistance
Time frame: Week 0,6
3H OGTT (75g glucose)
Changes in the gut microbiota
Time frame: Week 0,6
3 secondary outcomes
Inflammatory markers
Time frame: Week 0,4,6
Lipid metabolism
Time frame: Week 0,6
Total fat mass and abdominal fat
Time frame: Week 0,6
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 11 Jun 2014.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
Arne Astrup, MD, Professor principal investigator
Department of Human Nutrition, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus paracasei ssp paracasei F19 and Flax seed fibres in people with Obesity and Insulin Resistance, 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 4 inclusion and 7 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 11 Jun 2014. 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?
Insulin resistance (time frame: Week 0,6). The study lists 2 primary outcomes in all. 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 11 Jun 2014.