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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01433120
Enrollment
58
Registered
2011-09-13
Start date
2011-09-30
Completion date
2013-08-31
Last updated
2014-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance, Obesity

Keywords

Obesity, Insulin resistance, Microbiota, Probiotic, Prebiotic

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.

Interventions

DIETARY_SUPPLEMENTLactobacillus paracasei ssp paracasei F19

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

DIETARY_SUPPLEMENTFlax seed fibres

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

DIETARY_SUPPLEMENTMaltodextrin (Placebo)

Maltodextrin is dissolved in a glas of water once per day

Sponsors

Lundbeck Foundation
CollaboratorOTHER
Arla Foods
CollaboratorINDUSTRY
University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Insulin resistanceWeek 0,63H OGTT (75g glucose)
Changes in the gut microbiotaWeek 0,6

Secondary

MeasureTime frame
Inflammatory markersWeek 0,4,6
Lipid metabolismWeek 0,6
Total fat mass and abdominal fatWeek 0,6

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026