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

Primary Purpose

Obesity, Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Lactobacillus paracasei ssp paracasei F19
Flax seed fibres
Maltodextrin (Placebo)
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Obesity, Insulin resistance, Microbiota, Probiotic, Prebiotic

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Probiotic L. casei F19

Flax seed fibres

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Insulin resistance
3H OGTT (75g glucose)
Changes in the gut microbiota

Secondary Outcome Measures

Inflammatory markers
Lipid metabolism
Total fat mass and abdominal fat

Full Information

First Posted
September 9, 2011
Last Updated
June 10, 2014
Sponsor
University of Copenhagen
Collaborators
Lundbeck Foundation, Arla Foods
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1. Study Identification

Unique Protocol Identification Number
NCT01433120
Brief Title
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

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Lundbeck Foundation, Arla Foods

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Insulin Resistance
Keywords
Obesity, Insulin resistance, Microbiota, Probiotic, Prebiotic

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotic L. casei F19
Arm Type
Experimental
Arm Title
Flax seed fibres
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus paracasei ssp paracasei F19
Intervention Description
10^10 CFU of Lactobacillus paracasei F19 (dissolved in a glass of water once per day)
Intervention Type
Dietary Supplement
Intervention Name(s)
Flax seed fibres
Intervention Description
10 grams of flax seed fibres per day (baked into two breakfast buns)
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin (Placebo)
Intervention Description
Maltodextrin is dissolved in a glas of water once per day
Primary Outcome Measure Information:
Title
Insulin resistance
Description
3H OGTT (75g glucose)
Time Frame
Week 0,6
Title
Changes in the gut microbiota
Time Frame
Week 0,6
Secondary Outcome Measure Information:
Title
Inflammatory markers
Time Frame
Week 0,4,6
Title
Lipid metabolism
Time Frame
Week 0,6
Title
Total fat mass and abdominal fat
Time Frame
Week 0,6

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arne Astrup, MD, Professor
Organizational Affiliation
Department of Human Nutrition, University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
City
Frederiksberg C
ZIP/Postal Code
1958
Country
Denmark

12. IPD Sharing Statement

Links:
URL
http://www.ihe.life.ku.dk
Description
Related Info

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

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