Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-01-16 @ 4:56 AM
Study NCT ID:
NCT06587958
Status:
RECRUITING
Last Update Posted:
2025-05-04
First Post:
2024-09-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fermented Plant-based Portfolio Diet 4 Metabolic Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'A three-way randomized controlled crossover study will investigate the effects of fermented plant-based foods, non-fermented plant-based foods and the habitual diet on cardiometabolic risk factors. Each intervention will be ongoing for six weeks with six weeks washout in-between. During the fermented/non-fermented plant-based foods intervention, participants will add several corresponding food products to their habitual diet. The study has been dimensioned based on the estimated effect on hsCRP.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-30', 'studyFirstSubmitDate': '2024-09-05', 'studyFirstSubmitQcDate': '2024-09-05', 'lastUpdatePostDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The metabolome', 'timeFrame': '6 weeks', 'description': 'Investigate if the fecal, blood and urine metabolome differ between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.'}, {'measure': 'Gut microbiome profiles', 'timeFrame': '6 weeks', 'description': 'Investigate if the response to the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet depends on the gut microbiome profile high/low Prevotella.'}, {'measure': 'Transit time', 'timeFrame': '5-days', 'description': 'Investigate if transit time, measured by intake of sweet corn, differs for the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.'}], 'primaryOutcomes': [{'measure': 'C-reactive protein', 'timeFrame': '6 weeks', 'description': 'Investigate if c-reactive protein differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.'}], 'secondaryOutcomes': [{'measure': 'Glucose', 'timeFrame': '6 weeks', 'description': 'Investigate if glucose differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.'}, {'measure': 'Insulin', 'timeFrame': '6 weeks', 'description': 'Investigate if insulin differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.'}, {'measure': 'Liver parameters', 'timeFrame': '6 weeks', 'description': 'Investigate if liver parameters differ between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.'}, {'measure': 'Glycaemic variability', 'timeFrame': '2 weeks', 'description': 'Investigate if glycaemic variability differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.'}, {'measure': 'Mixed meal tolerance test', 'timeFrame': '1-day', 'description': 'Investigate if a mixed meal tolerance test causes different metabolic responses for the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet'}, {'measure': 'Gut microbiome', 'timeFrame': '6 weeks', 'description': 'Investigate if the fecal microbiome differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.'}, {'measure': 'Blood pressure', 'timeFrame': '6 weeks', 'description': 'Investigate if blood pressure differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.'}, {'measure': 'Blood lipid profile', 'timeFrame': '6 weeks', 'description': 'Description: Investigate if c-reactive protein differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metabolic Cardiovascular Syndrome']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the metabolic effects of a high-fiber portfolio diet based on fermented plant-based foods compared to a corresponding non-fermented plant-based diet and a control diet (habitual diet). This will be assessed across gut microbiome profiles (high/low Prevotella), focusing on cardiometabolic risk factors, particularly inflammation.\n\nA total of 100 men and women who meet all inclusion criteria and none of the exclusion criteria will be invited to participate. The study will employ a three-way randomized, controlled cross-over design, featuring six-week interventions separated by six-week washout periods. Participants will attend the clinic on 15 occasions, including screening visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Sign of metabolic syndrome\n\nWaist circumference \\> 102 cm/88 cm M/W and at least one of the following:\n\n* High density lipoprotein (HDL) ≤1.0 mmol/L men / HDL ≤1.3 mmol/L\n* Triglycerides ≥ 1,7 mmol/L\n* Blood pressure ≥130/85 mmHg\n* Fasting glucose ≥5.6 mmol/L\n\nOther inclusion criteria:\n\n* Signed informed consent\n* Willingness to consume the intervention foods\n* Body mass index 25-35 kg/m2\n* Hemoglobin 120-160 g/L\n* Serum thyroid-stimulating hormone (S-TSH) \\<4 mIU/L\n* Serum C-reactive protein (S-CRP) \\<5 mg/L\n* Access to a -18⁰ C freezer\n* Any medication stable for the last 14 days.\n\nExclusion Criteria:\n\n* Blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study.\n* Following any weight reduction program or having followed one during the last 6 months\n* Food allergies or intolerances\n* History of stomach or gastrointestinal conditions (Inflammatory bowel disease, Crohn's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery, Helicobacter infection, Peptic ulcer disease, untreated celiac disease, etc.)\n* Previous major gastrointestinal surgery\n* Pregnant or lactating or wish to become pregnant during the period of the study.\n* Unable to understand written and spoken Swedish\n* Lack of suitability for participation in the trial, for any reason, as judged by the medical doctor or PI.\n* Pharmacological medication with drugs known to affect the microbiota, e.g., antibiotics, within 6 months prior to baseline.\n* Intake of any probiotic pills or foods enriched in probiotics within 6 months prior to baseline.\n* Type I diabetes\n* Small bowel bacterial overgrowth\n* Diarrheal disease\n* Receiving pharmacological treatment for type II diabetes (treatments based on lifestyle interventions are acceptable, as long as it is compatible with the study protocol)\n* Using nicotine products on a daily basis (including chewing gum, patches, snus etc.)\n* History of heart failure or heart attack (TIA) within 1 year prior to screening\n* Thyroid disorder\n* Planned surgery within the next eight months"}, 'identificationModule': {'nctId': 'NCT06587958', 'acronym': 'FermDiHealth', 'briefTitle': 'Fermented Plant-based Portfolio Diet 4 Metabolic Health', 'organization': {'class': 'OTHER', 'fullName': 'Chalmers University of Technology'}, 'officialTitle': 'Fermented Plant-based Portfolio Diet 4 Metabolic Health (FermDiHealth)', 'orgStudyIdInfo': {'id': 'Chalmers-FermDiHealth'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fermented plant-based foods', 'interventionNames': ['Dietary Supplement: Fermented plant-based foods']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-fermented plant-based foods', 'interventionNames': ['Dietary Supplement: Non-fermented plant-based foods']}, {'type': 'OTHER', 'label': 'Habitual diet', 'interventionNames': ['Other: Habitual diet']}], 'interventions': [{'name': 'Fermented plant-based foods', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will daily consume five different types of fermented plant-based foods, in addition to their habitual diet.', 'armGroupLabels': ['Fermented plant-based foods']}, {'name': 'Non-fermented plant-based foods', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will daily consume five different types of non-fermented plant-based foods, in addition to their habitual diet.', 'armGroupLabels': ['Non-fermented plant-based foods']}, {'name': 'Habitual diet', 'type': 'OTHER', 'description': 'Participants will follow their habitual diet.', 'armGroupLabels': ['Habitual diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41346', 'city': 'Gothenburg', 'state': 'Ästra Götaland', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Rikard Landberg, PhD', 'role': 'CONTACT', 'email': 'rikard.landberg@chalmers.se', 'phone': '+46723509386'}], 'facility': 'Sahlgrenska University Hospital, Wallenberg Lab', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'centralContacts': [{'name': 'Elise Nordin, PhD', 'role': 'CONTACT', 'email': 'elise.nordin@chalmers.se', 'phone': '0046-730448420'}, {'name': 'Rikard Landberg, PhD', 'role': 'CONTACT', 'email': 'rikard.landberg@chalmers.se', 'phone': '+46723509386'}], 'overallOfficials': [{'name': 'Rikard Landberg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chalmers Univeristy of Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chalmers University of Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'KU Leuven', 'class': 'OTHER'}, {'name': 'Göteborg University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Rikard Landberg', 'investigatorAffiliation': 'Chalmers University of Technology'}}}}