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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01433120
• Other study ID #: B-244 LuCamp
• Status: Completed
• Phase: N/A
• First received: September 9, 2011
• Last updated: June 10, 2014
• Start date: September 2011
• Est. completion date: August 2013

Study information

• Verified date: June 2014
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: August 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Insulin Resistance
• Metabolic Diseases
• Obesity

Intervention

Dietary Supplement:
• Lactobacillus paracasei ssp paracasei F19
10^10 CFU of Lactobacillus paracasei F19 (dissolved in a glass of water once per day)
• Flax seed fibres
10 grams of flax seed fibres per day (baked into two breakfast buns)
• Maltodextrin (Placebo)
Maltodextrin is dissolved in a glas of water once per day

Locations

Country	Name	City	State
Denmark	Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen	Frederiksberg C

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	Arla Foods, Lundbeck Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin resistance	3H OGTT (75g glucose)	Week 0,6	No
Primary	Changes in the gut microbiota		Week 0,6	No
Secondary	Inflammatory markers		Week 0,4,6	No
Secondary	Lipid metabolism		Week 0,6	No
Secondary	Total fat mass and abdominal fat		Week 0,6	No

External Links

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