- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01433120
Targeting the Gut Microbiome to Investigate the Pathways of Progression From Obesity to Metabolic Diseases in an At-risk Population.
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Frederiksberg C, Denmark, 1958
- Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Post-menopausal
- BMI between 30-45 kg/m2
- Waist circumference > 80 cm
- High leukocyte count
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Maltodextrin is dissolved in a glas of water once per day
|
Experimental: Probiotic L. casei F19
|
10^10 CFU of Lactobacillus paracasei F19 (dissolved in a glass of water once per day)
|
Experimental: Flax seed fibres
|
10 grams of flax seed fibres per day (baked into two breakfast buns)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insulin resistance
Time Frame: Week 0,6
|
3H OGTT (75g glucose)
|
Week 0,6
|
Changes in the gut microbiota
Time Frame: Week 0,6
|
Week 0,6
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Inflammatory markers
Time Frame: Week 0,4,6
|
Week 0,4,6
|
Lipid metabolism
Time Frame: Week 0,6
|
Week 0,6
|
Total fat mass and abdominal fat
Time Frame: Week 0,6
|
Week 0,6
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arne Astrup, MD, Professor, Department of Human Nutrition, University of Copenhagen
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-244 LuCamp
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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