NCT01433120

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

June 11, 2014

Status Verified

June 1, 2014

Enrollment Period

9 months

First QC Date

September 9, 2011

Last Update Submit

June 10, 2014

Conditions

ObesityInsulin Resistance

Keywords

ObesityInsulin resistanceMicrobiotaProbioticPrebiotic

Outcome Measures

Primary Outcomes (2)

  • Insulin resistance

    3H OGTT (75g glucose)

    Week 0,6

  • Changes in the gut microbiota

    Week 0,6

Secondary Outcomes (3)

  • Inflammatory markers

    Week 0,4,6

  • Lipid metabolism

    Week 0,6

  • Total fat mass and abdominal fat

    Week 0,6

Study Arms (3)

Probiotic L. casei F19

EXPERIMENTAL
Dietary Supplement: Lactobacillus paracasei ssp paracasei F19

Flax seed fibres

EXPERIMENTAL
Dietary Supplement: Flax seed fibres

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Maltodextrin (Placebo)

Interventions

Lactobacillus paracasei ssp paracasei F19DIETARY_SUPPLEMENT

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

Probiotic L. casei F19
Flax seed fibresDIETARY_SUPPLEMENT

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

Flax seed fibres
Maltodextrin (Placebo)DIETARY_SUPPLEMENT

Maltodextrin is dissolved in a glas of water once per day

Placebo

Eligibility Criteria

Age40 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Post-menopausal
  • BMI between 30-45 kg/m2
  • Waist circumference \> 80 cm
  • High leukocyte count

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Frederiksberg C, 1958, Denmark

Location

Related Links

MeSH Terms

Conditions

ObesityInsulin Resistance

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Arne Astrup, MD, Professor

    Department of Human Nutrition, University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Professor

Study Record Dates

First Submitted

September 9, 2011

First Posted

September 13, 2011

Study Start

September 1, 2011

Primary Completion

June 1, 2012

Study Completion

August 1, 2013

Last Updated

June 11, 2014

Record last verified: 2014-06

Locations

DK(1)