Clinical trial NCT01433120: Targeting the Gut Microbiome to Investigate the Pathways of Progression From Obesity to Metabolic Diseases in an At-risk Population.
Official title: Targeting the Gut Microbiome to Investigate the Pathways of Progression From Obesity to Metabolic Diseases in an At-risk Population.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Insulin Resistance
Keywords: Obesity
Insulin resistance
Microbiota
Probiotic
Prebiotic
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Lundbeck Foundation
name: Arla Foods
First posted: 2011-09-13
Enrollment: 58
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Insulin resistance
timeFrame: Week 0,6
measure: Changes in the gut microbiota
timeFrame: Week 0,6
Secondary outcomes:
measure: Inflammatory markers
timeFrame: Week 0,4,6
measure: Lipid metabolism
timeFrame: Week 0,6
measure: Total fat mass and abdominal fat
timeFrame: Week 0,6
Other outcomes:
Locations:
city: Frederiksberg C
country: Denmark
facility: Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
Study officials:
affiliation: Department of Human Nutrition, University of Copenhagen
name: Arne Astrup, MD, Professor
role: PRINCIPAL_INVESTIGATOR
References: