Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-26 @ 8:05 AM
Study NCT ID:
NCT03444233
Status:
COMPLETED
Last Update Posted:
2018-02-23
First Post:
2018-02-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Short-term Fructose-enriched Diet on Serum Metabolome by Normal- and Over-weighed Women.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2009-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-16', 'studyFirstSubmitDate': '2018-02-16', 'studyFirstSubmitQcDate': '2018-02-16', 'lastUpdatePostDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'metabolite concentration', 'timeFrame': 'Participants will be followed for the time of four weeks.', 'description': 'The primary endpoint is the change of metabolite concentration after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.'}], 'secondaryOutcomes': [{'measure': 'fatty liver index', 'timeFrame': 'Participants will be followed for the time of four weeks.', 'description': 'Change in fatty liver index after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.'}, {'measure': 'Non-alcoholic fatty liver disease (NAFLD)', 'timeFrame': 'Participants will be followed for the time of four weeks.', 'description': 'Change in the classification of non-alcoholic fatty liver disease (NAFLD) based on ultrasound after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.'}, {'measure': 'Body weight', 'timeFrame': 'Participants will be followed for the time of four weeks.', 'description': 'Change from baseline in body weight after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.'}, {'measure': 'Blood pressure (systolic and diastolic)', 'timeFrame': 'Participants will be followed for the time of four weeks.', 'description': 'Change in blood pressure (systolic and diastolic) after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.'}, {'measure': 'GGT', 'timeFrame': 'Participants will be followed for the time of four weeks.', 'description': 'Change in GGT after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.'}, {'measure': 'GOT', 'timeFrame': 'Participants will be followed for the time of four weeks.', 'description': 'Change in GOT after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.'}, {'measure': 'GPT', 'timeFrame': 'Participants will be followed for the time of four weeks.', 'description': 'Change in GPT after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.'}, {'measure': 'AP', 'timeFrame': 'Participants will be followed for the time of four weeks.', 'description': 'Change in AP after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.'}, {'measure': 'Triglycerides', 'timeFrame': 'Participants will be followed for the time of four weeks.', 'description': 'Change in triglycerides after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.'}, {'measure': 'HDL', 'timeFrame': 'Participants will be followed for the time of four weeks.', 'description': 'Change in HDL after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.'}, {'measure': 'LDL', 'timeFrame': 'Participants will be followed for the time of four weeks.', 'description': 'Change in LDL after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.'}, {'measure': 'Fasting glucose', 'timeFrame': 'Participants will be followed for the time of four weeks.', 'description': 'Change in fasting glucose after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.'}, {'measure': 'BSR', 'timeFrame': 'Participants will be followed for the time of four weeks.', 'description': 'Change in BSR after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.'}, {'measure': 'Kreatinine', 'timeFrame': 'Participants will be followed for the time of four weeks.', 'description': 'Change in Kreatinine after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.'}, {'measure': 'Uric acid', 'timeFrame': 'Participants will be followed for the time of four weeks.', 'description': 'Change in uric acid after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.'}, {'measure': 'Urea', 'timeFrame': 'Participants will be followed for the time of four weeks.', 'description': 'Change in urea after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.'}, {'measure': 'Cholesterol', 'timeFrame': 'Participants will be followed for the time of four weeks.', 'description': 'Change in cholesterol after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.'}, {'measure': 'Ghrelin', 'timeFrame': 'Participants will be followed for the time of four weeks.', 'description': 'Change in ghrelin after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.'}, {'measure': 'Leptin', 'timeFrame': 'Participants will be followed for the time of four weeks.', 'description': 'Change in leptin after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Alcoholic Fatty Liver Disease', 'Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate how a high-fructose diet, either by high fructose intake from complex, natural foods or by fortifying the diet with corn syrup, affects the metabolism. Furthermore, it will be investigate if there are differences between obese and normal weight participants.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults, aged between 20 and 30 years\n* normal weighted (BMI ≤ 25 kg/m2) and obese (BMI 35-50 kg/m2)\n* written informed consent\n\nAt initial medical examination an anamnesis, physical examination, blood sample collection (10 ml) was performed to check for eligibility. Furthermore, a hydrogen breath test was performed to detect potential fructose intolerance\n\nExclusion Criteria:\n\n* smoking,\n* fructose intolerance/ -malabsorption,\n* pregnancy\n* chronic gastrointestinal diseases (e.g. chronic inflammatory bowel disease, irritable bowel syndrome, celiac disease etc.),\n* operation on the gastrointestinal tract (exclusively appendectomy)\n* anemia,\n* hepatic or renal disease\n* diabetes mellitus\n* consuming illnesses (e.g. cancer, acquired immunodeficiency syndrome (AIDS)) - drug intake affecting lipid or glucose metabolism (cholesterol- or glucose reducing or antihypertensive drugs, steroids, L-Thyroxin, antidepressants, weight reducing drugs).'}, 'identificationModule': {'nctId': 'NCT03444233', 'briefTitle': 'Impact of Short-term Fructose-enriched Diet on Serum Metabolome by Normal- and Over-weighed Women.', 'organization': {'class': 'OTHER', 'fullName': 'University of Hohenheim'}, 'officialTitle': 'Impact of Short-term Fructose-enriched Diet on Serum Metabolome by Normal- and Over-weighed Women.', 'orgStudyIdInfo': {'id': 'Fructose Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low f1 diet', 'description': 'low fructose diet week 1', 'interventionNames': ['Other: Diet']}, {'type': 'EXPERIMENTAL', 'label': 'fruit rich diet', 'description': 'fruit rich diet week 2', 'interventionNames': ['Other: Diet']}, {'type': 'EXPERIMENTAL', 'label': 'low f2 diet', 'description': 'low fructose diet week 3', 'interventionNames': ['Other: Diet']}, {'type': 'EXPERIMENTAL', 'label': 'HFCS rich diet', 'description': 'HFCS rich diet week 4', 'interventionNames': ['Other: Diet']}], 'interventions': [{'name': 'Diet', 'type': 'OTHER', 'otherNames': ['C-TruSweet 01750, Cargill Deutschland GmbH, Krefeld'], 'description': '7 days fruit-rich diet, 7 days HFCS-rich diet', 'armGroupLabels': ['HFCS rich diet', 'fruit rich diet', 'low f1 diet', 'low f2 diet']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Stephan C Bischoff', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Hohenheim'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Hohenheim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}