Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT01433120
Status:
COMPLETED
Last Update Posted:
2014-06-11
First Post:
2011-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Targeting the Gut Microbiome to Investigate the Pathways of Progression From Obesity to Metabolic Diseases in an At-risk Population.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C008315', 'term': 'maltodextrin'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-10', 'studyFirstSubmitDate': '2011-09-09', 'studyFirstSubmitQcDate': '2011-09-10', 'lastUpdatePostDateStruct': {'date': '2014-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin resistance', 'timeFrame': 'Week 0,6', 'description': '3H OGTT (75g glucose)'}, {'measure': 'Changes in the gut microbiota', 'timeFrame': 'Week 0,6'}], 'secondaryOutcomes': [{'measure': 'Inflammatory markers', 'timeFrame': 'Week 0,4,6'}, {'measure': 'Lipid metabolism', 'timeFrame': 'Week 0,6'}, {'measure': 'Total fat mass and abdominal fat', 'timeFrame': 'Week 0,6'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity', 'Insulin resistance', 'Microbiota', 'Probiotic', 'Prebiotic'], 'conditions': ['Obesity', 'Insulin Resistance']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ihe.life.ku.dk', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nThe study is based on the following hypotheses:\n\n* 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.\n* The effect on the metabolic risk markers can be correlated with changes in the gut microbiota (measured in faeces).\n\nAfter 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Post-menopausal\n* BMI between 30-45 kg/m2\n* Waist circumference \\> 80 cm\n* High leukocyte count\n\nExclusion Criteria:\n\n* Medically-treated Type 2 diabetes or dyslipidaemia\n* Use of antibiotics during the last 3 months\n* Use of pro- or prebiotic supplements during the last 6 weeks\n* Illnesses related to the gastro-intestinal tract\n* History of psychiatric diseases (incl. depression)\n* Liver disease\n* Alcohol abuse'}, 'identificationModule': {'nctId': 'NCT01433120', 'briefTitle': 'Targeting the Gut Microbiome to Investigate the Pathways of Progression From Obesity to Metabolic Diseases in an At-risk Population.', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Targeting the Gut Microbiome to Investigate the Pathways of Progression From Obesity to Metabolic Diseases in an At-risk Population.', 'orgStudyIdInfo': {'id': 'B-244 LuCamp'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic L. casei F19', 'interventionNames': ['Dietary Supplement: Lactobacillus paracasei ssp paracasei F19']}, {'type': 'EXPERIMENTAL', 'label': 'Flax seed fibres', 'interventionNames': ['Dietary Supplement: Flax seed fibres']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: Maltodextrin (Placebo)']}], 'interventions': [{'name': 'Lactobacillus paracasei ssp paracasei F19', 'type': 'DIETARY_SUPPLEMENT', 'description': '10\\^10 CFU of Lactobacillus paracasei F19 (dissolved in a glass of water once per day)', 'armGroupLabels': ['Probiotic L. casei F19']}, {'name': 'Flax seed fibres', 'type': 'DIETARY_SUPPLEMENT', 'description': '10 grams of flax seed fibres per day (baked into two breakfast buns)', 'armGroupLabels': ['Flax seed fibres']}, {'name': 'Maltodextrin (Placebo)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Maltodextrin is dissolved in a glas of water once per day', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1958', 'city': 'Frederiksberg C', 'country': 'Denmark', 'facility': 'Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen'}], 'overallOfficials': [{'name': 'Arne Astrup, MD, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Human Nutrition, University of Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lundbeck Foundation', 'class': 'OTHER'}, {'name': 'Arla Foods', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Professor', 'investigatorFullName': 'Arne Astrup', 'investigatorAffiliation': 'University of Copenhagen'}}}}