Targeting the Gut Microbiome to Investigate the Pathways of Progression From Obesity to Metabolic Diseases in an At-risk Population.

Not Applicable

Completed

• Conditions: Obesity; Insulin Resistance
• Interventions: Dietary Supplement: Lactobacillus paracasei ssp paracasei F19; Dietary Supplement: Flax seed fibres; Dietary Supplement: Maltodextrin (Placebo)

• Registration Number: NCT01433120
• Lead Sponsor: University of Copenhagen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-09
• Study First Submitted QC: 2011-09-10
• Study First Posted: 2011-09-13
• Primary Completion: 2012-06
• Study Completion: 2013-08
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-10
• Last Update Posted: 2014-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic L. casei F19	Lactobacillus paracasei ssp paracasei F19	-
Flax seed fibres	Flax seed fibres	-
Placebo	Maltodextrin (Placebo)	-

Primary Outcome Measures

Name	Time	Method
Insulin resistance	Week 0,6	3H OGTT (75g glucose)
Changes in the gut microbiota	Week 0,6

Secondary Outcome Measures

Name	Time	Method
Lipid metabolism	Week 0,6
Inflammatory markers	Week 0,4,6
Total fat mass and abdominal fat	Week 0,6

Trial Locations

Locations (1)

Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen; 🇩🇰 Frederiksberg C, Denmark