Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-01-04 @ 12:52 AM
Study NCT ID:
NCT07244458
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-28
First Post:
2025-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Peanuts and Nutrition-Related Outcomes
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015502', 'term': 'Absorptiometry, Photon'}], 'ancestors': [{'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003720', 'term': 'Densitometry'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change is Satiety as measured by the Hunger and Satiety Visual Analog Scales (VAS)', 'timeFrame': 'Baseline, End of study (12 weeks)', 'description': 'Participants will rate their perceived hunger, fullness, and desire to eat on a 100-mm scale, with endpoints ranging from "not at all" to "extremely" for each category.'}, {'measure': 'Change in fatigue as measured by the Fatigue Severity VAS-F Survey', 'timeFrame': 'Baseline, End of study (12 weeks)', 'description': 'Each item is presented on a 100-mm scale, with endpoints labeled to reflect the extremes of the sensation being measured (e.g., "Not at all tired" to "Extremely tired"). Participants will complete the VAS-F at consistent times of the day to minimize variability. Scores will be recorded both before and after meals to capture potential fluctuations in energy levels.'}, {'measure': 'Change in mood/well-being as measured by the Mental clarity, energy levels, and motivation VAS.', 'timeFrame': 'Baseline, End of study (12 weeks)', 'description': 'Each item is presented on a 100-mm scale, with endpoints labeled to reflect the extremes of being measured ranging from, for example, "not at all" to "extremely".'}, {'measure': 'Change in dietary quality as measured by Healthy Eating Index (HEI)', 'timeFrame': 'Baseline, End of study (12 weeks)', 'description': 'HEI scores measure how well a diet aligns with the Dietary Guidelines for Americans. The scores range from 0 to 100, with higher scores indicating foods align with key dietary recommendations and dietary patterns published in the Dietary Guidelines.'}, {'measure': 'Change in food enjoyment as measured by the Food Pleasure Scale (FPS)', 'timeFrame': 'Baseline, End of study (12 weeks)', 'description': 'The FPS is a validated 21-item tool designed to measure multiple dimensions of food-related enjoyment, including sensory characteristics (appearance, odor, taste, texture), expectations and desires (memories, habits, expectations, choices, needs), and other relevant factors. The importance of each item in relation to general pleasurable experiences of food is rated on a 5-point ordinal scale ranging from 1 ("Not important at all") to 5 ("Extremely important").'}, {'measure': 'Change in fasting glucose as measured by medical record review', 'timeFrame': 'Baseline, End of study (12 weeks)'}, {'measure': 'Change in HbA1c as measured by medical record review', 'timeFrame': 'Baseline, End of study (12 weeks)'}, {'measure': 'Change in total cholesterol as measured by medical record review', 'timeFrame': 'Baseline, End of study (12 weeks)'}, {'measure': 'Change in LDL-C as measured by medical record review', 'timeFrame': 'Baseline, End of study (12 weeks)'}, {'measure': 'Change in HDL-C as measured by medical record review', 'timeFrame': 'Baseline, End of study (12 weeks)'}, {'measure': 'Change in triglycerides as measured by medical record review', 'timeFrame': 'Baseline, End of study (12 weeks)'}, {'measure': 'Change in physical activity as measured by International Physical Activity Questionnaire (IPAQ)', 'timeFrame': 'Baseline, End of study (12 weeks)', 'description': 'The IPAQ short form consists of 7 questions designed to assess physical activity levels over the past 7 days in adults. The score is calculated using published guidelines and ranges from 0 to infinity and measures physical activity in median median MET-minutes/week. This is a continuous measure and is calculated as: Total MET-min/week = (Walk METs\\*min\\*days) + (Moderate activity METs\\*min\\*days) + Vigorous activity METs\\*min\\*days).'}], 'secondaryOutcomes': [{'measure': 'Change in body weight as measured by medical record review', 'timeFrame': 'Baseline, End of study (12 weeks)'}, {'measure': 'Change in waist circumference as measured by medical record review', 'timeFrame': 'Baseline, End of study (12 weeks)'}, {'measure': 'Change in hip circumference as measured by medical record review', 'timeFrame': 'Baseline, End of study (12 weeks)'}, {'measure': 'Change in fat mass as measured by DEXA scan', 'timeFrame': 'Baseline, End of study (12 weeks)'}, {'measure': 'Change in lean body mass as measured by DEXA scan', 'timeFrame': 'Baseline, End of study (12 weeks)'}, {'measure': 'Change in overall body fat percentage as measured by DEXA scan', 'timeFrame': 'Baseline, End of study (12 weeks)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dietary quality', 'Eating enjoyment', 'Satiety', 'Weight-related outcomes'], 'conditions': ['Dietary Change', 'Obesity & Overweight', 'Food Acceptance']}, 'descriptionModule': {'briefSummary': 'This study will look at how eating peanuts every day might affect participants weight, how healthy their diet is, and how they feel when eating. Investigators want to see if adding peanuts to meals for 12 weeks helps participants feel fuller, have more energy, and improve body composition. The study will include adults who have been taking GLP-1 medicines like semaglutide or tirzepatide for at least three months. Investigators also want to see if eating peanuts improves overall diet quality and health markers like tiredness and certain levels in blood.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals with a BMI ≥30 kg/m2 who intend to be continuously using semaglutide or tirzepatide for a clinical indication and remain on the therapy for at least 6 months\n\nExclusion Criteria:\n\n* No use or contraindication to use of a GLP-1 RA\n* Known allergy to nuts\n* Pregnant or breastfeeding\n* Incarcerated'}, 'identificationModule': {'nctId': 'NCT07244458', 'briefTitle': 'Dietary Peanuts and Nutrition-Related Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'Dietary Peanut Intake and Nutrition-Related Outcomes in Individuals Using GLP-1 Receptor Agonists: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'STUDY20250426'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Peanut Group', 'description': 'Participants in this group will eat 2 ounces, or 53 grams of dry-roasted, lightly salted (low sodium) each day along with their regular diet.', 'interventionNames': ['Dietary Supplement: Peanuts', 'Procedure: Dual-energy X-ray absorptiometry (DEXA) scans']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No Peanut Group', 'description': 'Participants in this group will continue eating regular diet without peanuts.', 'interventionNames': ['Procedure: Dual-energy X-ray absorptiometry (DEXA) scans']}], 'interventions': [{'name': 'Peanuts', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will eat 2 ounces, or about 53 grams, of dry-roasted, lightly salted peanuts each day along with their regular diet', 'armGroupLabels': ['Peanut Group']}, {'name': 'Dual-energy X-ray absorptiometry (DEXA) scans', 'type': 'PROCEDURE', 'description': 'DEXA scans will be used to measure body fat', 'armGroupLabels': ['No Peanut Group', 'Peanut Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Clevland', 'state': 'Ohio', 'country': 'United States', 'contacts': [{'name': 'Ian Neeland, MD', 'role': 'CONTACT', 'email': 'Ian.Neeland@UHhospitals.org', 'phone': '216-844-5965'}, {'name': 'Abigail Raffner, PhD, RD, LD', 'role': 'CONTACT', 'email': 'Abigail.Raffner@UHhospitals.org', 'phone': '216-368-0756'}], 'facility': 'University Hospitals Cleveland Medical Center'}], 'centralContacts': [{'name': 'Ian Neeland, MD', 'role': 'CONTACT', 'email': 'Ian.Neeland@UHhospitals.org', 'phone': '216-844-5965'}, {'name': 'Abigail Raffner, PhD, RD, LD', 'role': 'CONTACT', 'email': 'Abigail.Raffner@UHhospitals.org', 'phone': '216-368-0756'}], 'overallOfficials': [{'name': 'Ian Neeland, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}, {'name': 'Abigail Raffner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ian J. Neeland, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director, UH Center for Cardiovascular Prevention', 'investigatorFullName': 'Ian J. Neeland, MD', 'investigatorAffiliation': 'University Hospitals Cleveland Medical Center'}}}}