Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2026-02-01 @ 12:23 PM
Study NCT ID:
NCT05327868
Status:
COMPLETED
Last Update Posted:
2024-03-25
First Post:
2022-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lean and Obese: Dietary Inflammation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007249', 'term': 'Inflammation'}], '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': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018752', 'term': 'Diet, Fat-Restricted'}, {'id': 'D059305', 'term': 'Diet, High-Fat'}, {'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-02', 'size': 242127, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-12-01T16:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-02-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-21', 'studyFirstSubmitDate': '2022-02-28', 'studyFirstSubmitQcDate': '2022-04-07', 'lastUpdatePostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Glucose in response to a meal', 'timeFrame': 'Change over 5 hour MMT', 'description': 'Serum glycemic response to a meal'}, {'measure': 'Change in insulin in response to a meal', 'timeFrame': 'Change over 5 hour MMT', 'description': 'Serum glycemic response to a meal'}, {'measure': 'Inflammatory markers in response to a meal', 'timeFrame': 'Change over 5 hour MMT', 'description': 'serum TNF alpha, CRP and IL-6 (grams/volume)'}, {'measure': 'Lipopolysaccharide binding protein (LBP) in response to a meal', 'timeFrame': 'Change over 5 hour MMT', 'description': 'serum'}, {'measure': 'Change in Triglycerides in response to a meal', 'timeFrame': 'Change over 5 hour MMT', 'description': 'Serum lipid response to a meal (peak and AUC)'}, {'measure': 'Change in Osteocalcin in response to a meal', 'timeFrame': 'Change over 5 hour MMT', 'description': 'Serum bone formation and energy metabolism marker'}, {'measure': 'Change in PINP in response to a meal', 'timeFrame': 'Change over 5 hour MMT', 'description': 'Serum bone formation marker'}, {'measure': 'Change in CTX in response to a meal', 'timeFrame': 'Change over 5 hour MMT', 'description': 'Serum bone resorption marker'}, {'measure': 'Change in diet quality score', 'timeFrame': 'Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks', 'description': 'Nutrient analysis and HEI (higher score is better)'}, {'measure': 'Body composition in lean and obese weight groups', 'timeFrame': 'baseline characteristics', 'description': 'total tissue, fat-free soft tissue, fat, visceral adiposity'}], 'primaryOutcomes': [{'measure': 'Change in Endotoxin from Low to High fat diet', 'timeFrame': 'Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks', 'description': 'serum and stool'}, {'measure': 'Change in Microbiome composition', 'timeFrame': 'Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks', 'description': 'stool'}], 'secondaryOutcomes': [{'measure': 'Inflammatory markers', 'timeFrame': 'Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks', 'description': 'Serum IL-6, hsCRP, TNF-alpha, TLR4 (grams/volume)'}, {'measure': 'Zonulin', 'timeFrame': 'Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks', 'description': 'Serum'}, {'measure': 'Lipopolysaccharide binding protein (LBP)', 'timeFrame': 'Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks', 'description': 'Serum'}, {'measure': 'Toll like receptor-4 and Null 2 stimulation', 'timeFrame': 'Change from LFD (5 days) to HFD (5 days) over an average of 6 weeks', 'description': 'serum and the HEK cell reporter assay'}, {'measure': 'Endotoxin in response to a meal', 'timeFrame': 'Change over 5 hour MMT', 'description': 'Serum inflammatory response to a mixed meal tolerance test (MMT)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obesity', 'lean individuals', 'older adults', 'microbiome', 'dietary fat'], 'conditions': ['Obesity', 'Inflammation', 'Dietary Fat']}, 'referencesModule': {'references': [{'pmid': '40480607', 'type': 'DERIVED', 'citation': 'Ogilvie AR, Onishi JC, Schlussel Y, Kumar A, Haggblom MM, Kerkhof LJ, Shapses SA. Short-term high fat diet-induced metabolic endotoxemia in older individuals with obesity: a randomized crossover study. Am J Clin Nutr. 2025 Aug;122(2):601-611. doi: 10.1016/j.ajcnut.2025.06.001. Epub 2025 Jun 4.'}]}, 'descriptionModule': {'briefSummary': 'In the Lean and Obese Dietary Inflammation (LODI) study, the primary goal is to determine the effect of short-term intake of high dietary fat (5 days) compared to low fat intake (5 days) in a cross-over design in older adults (men and women) with normal body weight or obesity. Inflammation will be examined by measuring serum endotoxin and other markers, as well as the fecal microbiota.', 'detailedDescription': 'In the Lean and Obese Dietary Inflammation (LODI) study, short-term intake of a high-fat diet (HFD) that is also high in saturated fatty acids will be examined compared to a low-fat diet (LFD) in individuals who are normal body weight (BMI 19.5-24.9) or who have obesity (BMI of 30 - 40 kg/m2). To characterize persons at baseline, this study will examine body composition, and serum glucose, endotoxin, inflammation and intestinal permeability during fasting and in response to a mixed meal. Also, while it is known that long term intake of foods affects the microbiota, it is unclear whether short-term consumption of a HFD will shift towards a pro-inflammatory gut microbiota compared to a low fat intake. This will be tested in a cross-over design (5 days on a HFD, washout, and 5 days on a LFD) with order randomly assigned in older adults (50+ years of age) who have obesity or are normal weight, and will also be examined by estimated visceral adipose tissue level.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or Women\n* Age 50-79 years (only postmenopausal women \\> 2 years)\n* Body mass index (20-25 kg/m2; and 30-40 kg/m2)\\*\n\nExclusion Criteria:\n\n* Diagnosed with, active, or history of liver cirrhosis, chronic or persisting hepatitis\n* Diagnosed with, active, or history of cancer\n* History of gastrointestinal disease or surgical procedure for weight loss.\n* Diagnosed with immune diseases, type 2 diabetes, pancreatitis, or infectious diseases\n* Any surgery in the past 6 months\n* Currently using or have used antibiotics continuously \\> 3 days in the past 3 months\n* Regular use of medications for that affect the gastrointestinal tract, cholecystitis, urinary tract infection, severe organic diseases including coronary heart disease, myocardial infarction, infectious diseases including pulmonary tuberculosis and AIDS\n* Known allergy or intolerance to any ingredients in the dietary intervention program\n* Alcohol or illicit drug abuse\n* Current Smoker or have quit smoking in the past 3 months\n* Recent colonoscopy (within the previous two months)\n* Inability to follow any of the experimental diets (including low or high fat diet) or to perform the collections required for this study\n* Participants will also be excluded if they have extreme dietary habits, extreme levels of physical or athletic activity, or by changes in body weight \\>5 lbs. during the last 6 months\n* Uncontrolled hypertension or uncontrolled hyperlipidemia in abnormal ranges.\n* Participation in another clinical research trial that may interfere with the results of this study.\n\n * As needed, BMI (kg/m2) will be adjusted accordingly for Asian lean and obese definitions'}, 'identificationModule': {'nctId': 'NCT05327868', 'acronym': 'LODI', 'briefTitle': 'Lean and Obese: Dietary Inflammation', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Dietary Inflammation in Older Adults: the Role of Obesity', 'orgStudyIdInfo': {'id': 'Pro2019002228'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Obese', 'description': 'BMI in Obesity range', 'interventionNames': ['Other: Low Fat Diet (LFD)', 'Other: High Fat Diet (HFD)']}, {'type': 'EXPERIMENTAL', 'label': 'Normal weight (lean)', 'description': 'Normal body weight', 'interventionNames': ['Other: Low Fat Diet (LFD)', 'Other: High Fat Diet (HFD)']}], 'interventions': [{'name': 'Low Fat Diet (LFD)', 'type': 'OTHER', 'otherNames': ['low fat diet'], 'description': 'Subjects will be asked to adhere to a low fat diet (assigned in random order) and be counseled by a dietitian using 5 days of sample menus, monitored online using a shared nutrient analysis program, and supplied with low fat foods to increase compliance', 'armGroupLabels': ['Normal weight (lean)', 'Obese']}, {'name': 'High Fat Diet (HFD)', 'type': 'OTHER', 'otherNames': ['high fat (high SFA) diet'], 'description': 'Subjects will be asked to adhere to a high fat diet that is rich in SFAs (assigned in random order) and be counseled by a dietitian using sample 5 days of menus, monitored online using a shared nutrient analysis program, and supplied with high fat foods to increase compliance', 'armGroupLabels': ['Normal weight (lean)', 'Obese']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers University', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}], 'overallOfficials': [{'name': 'Sue Shapses, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers, the State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data that underlie the results and after deidentification will be shared upon request for researchers who provide a methodologically sound proposal (and IRB approved).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sue A. Shapses, Ph.D., RD', 'investigatorAffiliation': 'Rutgers, The State University of New Jersey'}}}}