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OpenTrials
Completed

NCT Number: 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.

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Key information

Age range

40 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen

Frederiksberg C, 1958, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactobacillus paracasei ssp paracasei F19

Dietary Supplement

10^10 CFU of Lactobacillus paracasei F19 (dissolved in a glass of water once per day)

Flax seed fibres

Dietary Supplement

10 grams of flax seed fibres per day (baked into two breakfast buns)

Maltodextrin (Placebo)

Dietary Supplement

Maltodextrin is dissolved in a glas of water once per day

Primary outcomes

  1. Insulin resistance

    Time frame: Week 0,6

    3H OGTT (75g glucose)

  2. Changes in the gut microbiota

    Time frame: Week 0,6

Secondary outcomes

  1. Inflammatory markers

    Time frame: Week 0,4,6

  2. Lipid metabolism

    Time frame: Week 0,6

  3. Total fat mass and abdominal fat

    Time frame: Week 0,6

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Arla Foods
  • Lundbeck Foundation

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Sep 13, 2011
Registry last updated
Jun 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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