Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:04 PM
Study NCT ID:
NCT04203758
Status:
COMPLETED
Last Update Posted:
2021-07-19
First Post:
2019-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High Fiber Rye Foods for Body Weight and Body Fat Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 255}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-16', 'studyFirstSubmitDate': '2019-12-13', 'studyFirstSubmitQcDate': '2019-12-17', 'lastUpdatePostDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigate if there is a difference in body weight at week 12', 'timeFrame': '12 weeks', 'description': 'Measured on a scale'}, {'measure': 'Investigate if there is a difference in body fat mass at week 12', 'timeFrame': '12 weeks', 'description': 'Measured by dual energy x-ray absorptiometry'}], 'secondaryOutcomes': [{'measure': 'Investigate if there are differences in subjective appetite ratings', 'timeFrame': '0 weeks, 6 weeks and 12 weeks.', 'description': 'Measured by visual analogue scale (assessing hunger fullness and desire to eat), throughout a whole day (8:00-21:00), at baseline, week 6 and week 12.'}, {'measure': 'Investigate if differences in primary endpoints (body weight) are apparent at week 6', 'timeFrame': '6 weeks', 'description': 'Measured on a scale'}, {'measure': 'Investigate if differences in primary endpoints (fat mass) are apparent at week 6', 'timeFrame': '6 weeks', 'description': 'Measured by dual energy x-ray absorptiometry'}, {'measure': 'Investigate if lean body mass differs between intervention groups after 6 and 12 weeks of intervention', 'timeFrame': '6 weeks and 12 weeks', 'description': 'Measured by dual energy x-ray absorptiometry'}, {'measure': 'Investigate if abdominal fat mass differs between intervention groups after 6 and 12 weeks of intervention', 'timeFrame': '6 weeks and 12 weeks', 'description': 'Measured by dual energy x-ray absorptiometry'}, {'measure': 'Investigate if fasting plasma triglycerides differ between groups', 'timeFrame': '6 weeks and 12 weeks'}, {'measure': 'Investigate if fasting plasma low-density lipoprotein cholesterol differ between groups', 'timeFrame': '6 weeks and 12 weeks'}, {'measure': 'Investigate if fasting plasma high-density lipoprotein cholesterol differ between groups', 'timeFrame': '6 weeks and 12 weeks'}, {'measure': 'Investigate if fasting plasma total cholesterol differ between groups', 'timeFrame': '6 weeks and 12 weeks'}, {'measure': 'Investigate if fasting plasma glucose differ between groups', 'timeFrame': '6 weeks and 12 weeks'}, {'measure': 'Investigate if fasting serum insulin differ between groups', 'timeFrame': '6 weeks and 12 weeks'}, {'measure': 'Investigate if C-reactive protein differ between groups', 'timeFrame': '6 weeks and 12 weeks'}, {'measure': 'Investigate if gut microbiota composition is affected by the intervention', 'timeFrame': '6 weeks and 12 weeks', 'description': 'Gut microbiota composition will be analyzed using 16S ribosomal ribonucleic acid (rRNA) sequencing'}, {'measure': 'Investigate if hip circumference differ between intervention groups', 'timeFrame': '6 weeks and 12 weeks'}, {'measure': 'Investigate if waist circumference differ between intervention', 'timeFrame': '6 weeks and 12 weeks'}, {'measure': 'Investigate if sagittal height differ between intervention groups', 'timeFrame': '6 weeks and 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Overweight']}, 'descriptionModule': {'briefSummary': 'The overall aim of this study is to investigate whether a diet rich in rye fiber from wholegrain rye, compared to refined wheat, as part of a hypo-caloric diet leads to larger weight loss and lower body fat content after 12 weeks of intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women\n* Age 30-70 y\n* BMI 27-35 kg/m2\n* Hemoglobin ≥117g/l for women and for men ≥134g/l\n* Thyroid stimulating hormone (TSH) ≤4.30 mIU/L\n* Low density lipoprotein (LDL) cholesterol ≤5.30 mmol/L\n* Triglycerides ≤2.60 mmol/L\n* Signed informed consent\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* Unable to satisfactorily complete the 3-day weighted food record between screening visits.\n* Unable to lose ≥0.5 kg during the run-in period for men and women not having menstruation during the run-in period\n* Increased body weight, despite reported adherence to dietary intake for women with menstruation during the run-in period.\n* Using nicotine products on a daily basis (incl. chewing gum, patches, snus etc.)\n* Using e-cigarettes (regardless of nicotine content)\n* Following any weight reduction program or having followed one during the last 6 months prior to visit 1.\n* Diastolic blood pressure 105 mmHg or more at visit 1\n* Systolic blood pressure 160 mmHg or more at visit 1\n* History of stomach or gastrointestinal conditions (Inflammatory bowel disease, Crohn's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery etc.)\n* More than 10 hours physical activity per week\n* History of heart failure or heart attack within 1 year prior to screening\n* Having type I diabetes\n* Receiving pharmacological treatment for type II diabetes (treatments based on life style interventions are acceptable, as long as they are compatible with the study protocol)\n* Previous gastrointestinal surgery, with the exception of minor surgeries such removal of appendix or gall bladder at least 6 months prior to screening.\n* Thyroid disorder\n* History of eating disorder\n* History of drug or alcohol abuse\n* Stroke or transient ischemic attack (TIA) within 1 year prior to screening\n* Consumption of drugs aimed at weight management or drugs affecting body weight to a degree that is considered unsuitable for study participation by responsible physician.\n* Pregnant, lactation or planning a pregnancy within the timeframe of the study. Pregnancy must have ended at least 6 months prior to screening, and lactation must have ended at least 1 month prior to screening.\n* Food allergies or intolerances preventing consumption of any products included in the study\n* Strict vegetarian (participants must be able to consume the standardized meals used for appetite assessment)\n* Unable to sufficiently understand written and spoken Swedish to provide written consent and understand information and instructions from the study personal.\n* Lack of suitability for participation in the study, for any reason, as judged by the medical doctor or PI."}, 'identificationModule': {'nctId': 'NCT04203758', 'acronym': 'RyeWeight2', 'briefTitle': 'High Fiber Rye Foods for Body Weight and Body Fat Reduction', 'organization': {'class': 'OTHER', 'fullName': 'Chalmers University of Technology'}, 'officialTitle': 'High Fiber Rye Foods for Body Weight and Body Fat Reduction - The RyeWeight2 Study, a Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'RW2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Wholegrain rye products with a high content of dietary fiber', 'description': 'Cereal products based on wholegrain rye', 'interventionNames': ['Other: Cereal products based on rye']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Refined wheat products with a low content of dietary fiber', 'description': 'Cereal products based on refined wheat', 'interventionNames': ['Other: Cereal products based on wheat']}], 'interventions': [{'name': 'Cereal products based on rye', 'type': 'OTHER', 'description': 'Participants will receive a fixed amount of rye based cereals products, corresponding to approx 650 kcal/day.', 'armGroupLabels': ['Wholegrain rye products with a high content of dietary fiber']}, {'name': 'Cereal products based on wheat', 'type': 'OTHER', 'description': 'Participants will receive a fixed amount of wheat based cereals products, corresponding to approx 650 kcal/day.', 'armGroupLabels': ['Refined wheat products with a low content of dietary fiber']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Chalmers University of Technology', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Rikard Landberg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chalmers University of Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chalmers University of Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Rikard Landberg', 'investigatorAffiliation': 'Chalmers University of Technology'}}}}