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

University of Copenhagen

Status: Completed

Conditions: Insulin Resistance; Obesity

Treatments: Dietary Supplement: Maltodextrin (Placebo); Dietary Supplement: Flax seed fibres; Dietary Supplement: Lactobacillus paracasei ssp paracasei F19

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01433120

B-244 LuCamp

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: Female

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 3 patient groups, including a placebo group

Probiotic L. casei F19

Experimental group

Treatment:

Dietary Supplement: Lactobacillus paracasei ssp paracasei F19

Flax seed fibres

Experimental group

Treatment:

Dietary Supplement: Flax seed fibres

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Maltodextrin (Placebo)