Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-01 @ 3:18 PM
Study NCT ID:
NCT03134235
Status:
COMPLETED
Last Update Posted:
2017-05-23
First Post:
2017-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a 4-week Raw, Plant-based Diet on Anthropometric and Cardiovascular Risk Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2017-06-05', 'unreleaseDateUnknown': True}, {'resetDate': '2017-10-30', 'releaseDate': '2017-06-07'}], 'estimatedResultsFirstSubmitDate': '2017-06-05'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004035', 'term': 'Diet Therapy'}], 'ancestors': [{'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Repeated measures, single group design.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-19', 'studyFirstSubmitDate': '2017-04-26', 'studyFirstSubmitQcDate': '2017-04-26', 'lastUpdatePostDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in body weight', 'timeFrame': 'Baseline, follow-up weeks 1-4', 'description': 'Weight (kg) was documented at baseline and during 4 additional weekly follow-up visits'}, {'measure': 'Change in serum low-density lipoprotein cholesterol (LDL)', 'timeFrame': 'Baseline and 4-weeks', 'description': 'LDL cholesterol (mg/dL) was documented at baseline and after 4-weeks'}, {'measure': 'Change in blood pressure', 'timeFrame': 'Baseline, follow-up weeks 1-4', 'description': 'Systolic and diastolic blood pressure (mmHg) was documented at baseline and during 4 additional weekly follow-up visits'}], 'secondaryOutcomes': [{'measure': 'Change in heart rate', 'timeFrame': 'Baseline, follow-up weeks 1-4', 'description': 'Heart rate (beats/min) was documented at baseline and during 4 additional weekly follow-up visits'}, {'measure': 'Change in waist circumference', 'timeFrame': 'Baseline, follow-up weeks 1-4', 'description': 'Waist circumference (cm) was documented at baseline and during 4 additional weekly follow-up visits'}, {'measure': 'Change in serum total cholesterol', 'timeFrame': 'Baseline and 4-weeks', 'description': 'Serum total cholesterol (mg/dL) was documented at baseline and after 4-weeks'}, {'measure': 'Change in serum high-density lipoprotein cholesterol', 'timeFrame': 'Baseline and 4-weeks', 'description': 'Serum HDL (mg/dL) was documented at baseline and after 4-weeks'}, {'measure': 'Change in serum triglycerides', 'timeFrame': 'Baseline and 4-weeks', 'description': 'Triglycerides mg/dL was documented at baseline and after 4-weeks'}, {'measure': 'Change in serum insulin', 'timeFrame': 'Baseline and 4-weeks', 'description': 'Insulin (uU/mL) was documented at baseline and after 4-weeks'}, {'measure': 'Change in serum glucose', 'timeFrame': 'Baseline and 4-weeks', 'description': 'Serum glucose (mg/dL) was documented at baseline and after 4-weeks'}, {'measure': 'Change in serum hemoglobin A1c (HgA1c)', 'timeFrame': 'Baseline and 4-weeks', 'description': 'HgA1c (%) was documented at baseline and after 4-weeks'}, {'measure': 'Change in c-reactive protein (CRP)', 'timeFrame': 'Baseline and 4-weeks', 'description': 'CRP (mg/L) was documented at baseline and after 4-weeks'}, {'measure': 'Change in medication use', 'timeFrame': 'Baseline, follow-up weeks 1-4', 'description': 'Medication needs were assessed weekly'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension', 'Elevated Cholesterol', 'Overweight and Obesity']}, 'referencesModule': {'references': [{'pmid': '16873779', 'type': 'BACKGROUND', 'citation': 'Barnard ND, Cohen J, Jenkins DJ, Turner-McGrievy G, Gloede L, Jaster B, Seidl K, Green AA, Talpers S. A low-fat vegan diet improves glycemic control and cardiovascular risk factors in a randomized clinical trial in individuals with type 2 diabetes. Diabetes Care. 2006 Aug;29(8):1777-83. doi: 10.2337/dc06-0606.'}, {'pmid': '18937894', 'type': 'BACKGROUND', 'citation': 'Bazzano LA. Effects of soluble dietary fiber on low-density lipoprotein cholesterol and coronary heart disease risk. Curr Atheroscler Rep. 2008 Dec;10(6):473-7. doi: 10.1007/s11883-008-0074-3.'}, {'pmid': '20815907', 'type': 'BACKGROUND', 'citation': 'Bloomer RJ, Kabir MM, Canale RE, Trepanowski JF, Marshall KE, Farney TM, Hammond KG. Effect of a 21 day Daniel Fast on metabolic and cardiovascular disease risk factors in men and women. Lipids Health Dis. 2010 Sep 3;9:94. doi: 10.1186/1476-511X-9-94.'}, {'pmid': '22684631', 'type': 'BACKGROUND', 'citation': 'Boeing H, Bechthold A, Bub A, Ellinger S, Haller D, Kroke A, Leschik-Bonnet E, Muller MJ, Oberritter H, Schulze M, Stehle P, Watzl B. Critical review: vegetables and fruit in the prevention of chronic diseases. Eur J Nutr. 2012 Sep;51(6):637-63. doi: 10.1007/s00394-012-0380-y. Epub 2012 Jun 9.'}, {'pmid': '14749225', 'type': 'BACKGROUND', 'citation': 'Djousse L, Arnett DK, Coon H, Province MA, Moore LL, Ellison RC. Fruit and vegetable consumption and LDL cholesterol: the National Heart, Lung, and Blood Institute Family Heart Study. Am J Clin Nutr. 2004 Feb;79(2):213-7. doi: 10.1093/ajcn/79.2.213.'}, {'pmid': '24636393', 'type': 'BACKGROUND', 'citation': 'Fraser G, Katuli S, Anousheh R, Knutsen S, Herring P, Fan J. Vegetarian diets and cardiovascular risk factors in black members of the Adventist Health Study-2. Public Health Nutr. 2015 Feb;18(3):537-45. doi: 10.1017/S1368980014000263. Epub 2014 Mar 17.'}, {'pmid': '11288049', 'type': 'BACKGROUND', 'citation': 'Jenkins DJ, Kendall CW, Popovich DG, Vidgen E, Mehling CC, Vuksan V, Ransom TP, Rao AV, Rosenberg-Zand R, Tariq N, Corey P, Jones PJ, Raeini M, Story JA, Furumoto EJ, Illingworth DR, Pappu AS, Connelly PW. Effect of a very-high-fiber vegetable, fruit, and nut diet on serum lipids and colonic function. Metabolism. 2001 Apr;50(4):494-503. doi: 10.1053/meta.2001.21037.'}, {'pmid': '16177198', 'type': 'BACKGROUND', 'citation': 'Koebnick C, Garcia AL, Dagnelie PC, Strassner C, Lindemans J, Katz N, Leitzmann C, Hoffmann I. Long-term consumption of a raw food diet is associated with favorable serum LDL cholesterol and triglycerides but also with elevated plasma homocysteine and low serum HDL cholesterol in humans. J Nutr. 2005 Oct;135(10):2372-8. doi: 10.1093/jn/135.10.2372.'}, {'pmid': '24871675', 'type': 'BACKGROUND', 'citation': 'Le LT, Sabate J. Beyond meatless, the health effects of vegan diets: findings from the Adventist cohorts. Nutrients. 2014 May 27;6(6):2131-47. doi: 10.3390/nu6062131.'}, {'pmid': '25684089', 'type': 'BACKGROUND', 'citation': 'Macknin M, Kong T, Weier A, Worley S, Tang AS, Alkhouri N, Golubic M. Plant-based, no-added-fat or American Heart Association diets: impact on cardiovascular risk in obese children with hypercholesterolemia and their parents. J Pediatr. 2015 Apr;166(4):953-9.e1-3. doi: 10.1016/j.jpeds.2014.12.058. Epub 2015 Feb 12.'}, {'pmid': '23695207', 'type': 'BACKGROUND', 'citation': 'Mishra S, Xu J, Agarwal U, Gonzales J, Levin S, Barnard ND. A multicenter randomized controlled trial of a plant-based nutrition program to reduce body weight and cardiovascular risk in the corporate setting: the GEICO study. Eur J Clin Nutr. 2013 Jul;67(7):718-24. doi: 10.1038/ejcn.2013.92. Epub 2013 May 22.'}, {'pmid': '24780090', 'type': 'BACKGROUND', 'citation': 'Ras RT, Geleijnse JM, Trautwein EA. LDL-cholesterol-lowering effect of plant sterols and stanols across different dose ranges: a meta-analysis of randomised controlled studies. Br J Nutr. 2014 Jul 28;112(2):214-9. doi: 10.1017/S0007114514000750. Epub 2014 Apr 29.'}, {'pmid': '17890496', 'type': 'BACKGROUND', 'citation': 'Turner-McGrievy GM, Barnard ND, Scialli AR. A two-year randomized weight loss trial comparing a vegan diet to a more moderate low-fat diet. Obesity (Silver Spring). 2007 Sep;15(9):2276-81. doi: 10.1038/oby.2007.270.'}, {'pmid': '27306085', 'type': 'BACKGROUND', 'citation': 'Wu L, Sun D, He Y. Fruit and vegetables consumption and incident hypertension: dose-response meta-analysis of prospective cohort studies. J Hum Hypertens. 2016 Oct;30(10):573-80. doi: 10.1038/jhh.2016.44. Epub 2016 Jun 16.'}, {'pmid': '24566947', 'type': 'BACKGROUND', 'citation': 'Yokoyama Y, Nishimura K, Barnard ND, Takegami M, Watanabe M, Sekikawa A, Okamura T, Miyamoto Y. Vegetarian diets and blood pressure: a meta-analysis. JAMA Intern Med. 2014 Apr;174(4):577-87. doi: 10.1001/jamainternmed.2013.14547.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effects of a prescribed 4-week raw, plant-based dietary intervention in the treatment of excess body weight, hypercholesterolemia, and hypertension in the clinical setting.', 'detailedDescription': 'Plant-based diets have emerged in the literature as effective therapeutic strategies in the reduction of body weight, serum lipids and blood pressure. In addition, raw fruit and vegetable consumption has also been associated with the reduction of these clinical indicators.\n\nParticipants were instructed to follow a prescribed, raw, plant-based dietary intervention for four weeks. All animal products, including eggs and dairy, were excluded. Cooked foods, free oils, soda, alcohol and coffee were also to be excluded. All meals and snacks were provided to the participants for the full duration of the intervention. Emphasized were raw fruits and vegetables, while seeds, avocado, raw oats, raw buckwheat, and dehydrated foods were prepared as condiments. Vitamin, herbal, and mineral supplements were to be discontinued unless otherwise clinically indicated. Participants were not advised to alter their exercise habits.\n\nParticipants came to a total of 4 follow-up visits. A laboratory panel was obtained at baseline and at 4-weeks. A 24-hour recall was also conducted at baseline and at 4-weeks. Anthropometrics, hemodynamics, and medication needs were assessed on a weekly basis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index ≥25.0 kg/m\\^2\n* Serum low-density lipoprotein cholesterol concentration ≥100\n* Systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90\n\nExclusion Criteria:\n\n* Tobacco use\n* Drug abuse\n* Excessive alcohol consumption (\\>2 glasses of wine or alcohol equivalent per day for men or \\>1 glass of wine or alcohol equivalent for woman)\n* Current cancer diagnosis\n* Estimated glomerular filtration rate \\<60 mg/dL\n* Clinically defined infection\n* Mental disability\n* Hospitalization \\<6 months\n* Previous exposure to plant-based diet'}, 'identificationModule': {'nctId': 'NCT03134235', 'briefTitle': 'Effects of a 4-week Raw, Plant-based Diet on Anthropometric and Cardiovascular Risk Factors', 'organization': {'class': 'OTHER', 'fullName': "Texas Woman's University"}, 'officialTitle': 'A 4-week Defined, Raw, Plant-based Diet Improves Anthropometric, Hemodynamic, and Other Cardiovascular Risk Factors', 'orgStudyIdInfo': {'id': '19279'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Raw, plant-based diet', 'description': 'A raw, plant-based diet was prescribed for 4 weeks.', 'interventionNames': ['Other: Dietary Intervention']}], 'interventions': [{'name': 'Dietary Intervention', 'type': 'OTHER', 'description': 'Subjects consumed a raw, vegan diet for 4-weeks with an emphasis on raw fruit and vegetable consumption.', 'armGroupLabels': ['Raw, plant-based diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77025', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Montgomery Heart & Wellness', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Rami Najjar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Texas Woman's University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Texas Woman's University", 'class': 'OTHER'}, 'collaborators': [{'name': 'Montgomery Heart & Wellness', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Student', 'investigatorFullName': 'Rami Najjar', 'investigatorAffiliation': "Texas Woman's University"}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-06-05', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2017-06-07', 'type': 'RELEASE'}, {'date': '2017-10-30', 'type': 'RESET'}], 'unpostedResponsibleParty': "Rami Najjar, Student, Texas Woman's University"}}}}