Ignite Creation Date:
2025-12-24 @ 12:07 PM
Ignite Modification Date:
2026-02-25 @ 9:47 PM
Study NCT ID:
NCT02573961
Status:
WITHDRAWN
Last Update Posted:
2021-09-08
First Post:
2015-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laser Acupuncture Versus High Protein/Low Carbohydrate Diet on Endothelial Markers in Obese Females
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000076107', 'term': 'Diet, High-Protein Low-Carbohydrate'}, {'id': 'D031204', 'term': 'Caloric Restriction'}], 'ancestors': [{'id': 'D050528', 'term': 'Diet, Carbohydrate-Restricted'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000073600', 'term': 'Diet, High-Protein'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D002149', 'term': 'Energy Intake'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'This was a topic for a thesis project where the topic was changed', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-31', 'studyFirstSubmitDate': '2015-10-05', 'studyFirstSubmitQcDate': '2015-10-08', 'lastUpdatePostDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'weight loss', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'decrease cardiovascular risks', 'timeFrame': '8 weeks', 'description': 'endothelial markers , serum insulin and insulin resistance changes from baseline.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '11854119', 'type': 'BACKGROUND', 'citation': "Ziccardi P, Nappo F, Giugliano G, Esposito K, Marfella R, Cioffi M, D'Andrea F, Molinari AM, Giugliano D. Reduction of inflammatory cytokine concentrations and improvement of endothelial functions in obese women after weight loss over one year. Circulation. 2002 Feb 19;105(7):804-9. doi: 10.1161/hc0702.104279."}, {'pmid': '22935440', 'type': 'BACKGROUND', 'citation': "Soenen S, Bonomi AG, Lemmens SG, Scholte J, Thijssen MA, van Berkum F, Westerterp-Plantenga MS. Relatively high-protein or 'low-carb' energy-restricted diets for body weight loss and body weight maintenance? Physiol Behav. 2012 Oct 10;107(3):374-80. doi: 10.1016/j.physbeh.2012.08.004. Epub 2012 Aug 19."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effects of laser acupuncture and high protein low carbohydrate diet on the treatment of obesity and lowering of endothelial markers.', 'detailedDescription': 'Sixty females above 20 years of age with a body mass index (BMI) of over 30 kg/m2 will be divided into three groups (20 in each): two experimental groups (laser; high protein low carbohydrate diet) and control. Each subject will receive the treatment relevant to their group, in addition to obtaining 3 days dietary recalls and measurements including BMI, serum insulin and endothelial markers. Laser and control group will receive 24 activated or sham laser acupuncture treatments. High protein low carbohydrate group will be instructed to take a tailored high protein/low carbohydrate diet.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* obese females of BMI more than 30 kg/m2, and\n* of age range from 20 to 50 years.\n\nExclusion Criteria:\n\n* medical history of chronic diseases,\n* pregnancy,\n* photosensitivity reactions to laser treatment,\n* a pacemaker,\n* medications known to affect one's weight up to 1 month in advance, or\n* are unwilling to comply with the study protocol."}, 'identificationModule': {'nctId': 'NCT02573961', 'briefTitle': 'Laser Acupuncture Versus High Protein/Low Carbohydrate Diet on Endothelial Markers in Obese Females', 'organization': {'class': 'OTHER', 'fullName': 'National Research Centre, Egypt'}, 'officialTitle': 'Laser Acupuncture Versus High Protein/Low Carbohydrate Diet on Endothelial Markers in Obese Females. A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'NRCEgypt'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'laser', 'description': 'Subjects will receive 24 activated laser acupuncture group treatments. The laser will be applied for 10 seconds to each of the selected acupuncture points. In addition they will be instructed to take a tailored low caloric diet', 'interventionNames': ['Device: Laser acupuncture', 'Behavioral: low caloric diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'high protein low carbohydrate diet', 'description': 'Subjects will be instructed to take a tailored high protein/low carbohydrate/low caloric diet.', 'interventionNames': ['Behavioral: high protein low carbohydrate diet']}, {'type': 'SHAM_COMPARATOR', 'label': 'control', 'description': 'Subjects in the control group will undergo sham laser acupuncture treatment with no laser power output. In addition they will be instructed to take a tailored low caloric diet .', 'interventionNames': ['Device: Laser acupuncture', 'Behavioral: low caloric diet']}], 'interventions': [{'name': 'Laser acupuncture', 'type': 'DEVICE', 'description': 'GaAlAs semiconductor diode Laser Phototherapy Device', 'armGroupLabels': ['control', 'laser']}, {'name': 'high protein low carbohydrate diet', 'type': 'BEHAVIORAL', 'description': 'A tailored high protein/low carbohydrate/low caloric diet', 'armGroupLabels': ['high protein low carbohydrate diet']}, {'name': 'low caloric diet', 'type': 'BEHAVIORAL', 'description': 'Tailored balanced low caloric diet', 'armGroupLabels': ['control', 'laser']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12311', 'city': 'Cairo', 'state': 'Giza Governorate', 'country': 'Egypt', 'facility': 'National Research Centre'}], 'overallOfficials': [{'name': 'Neveen H Abou El-Soud, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Research Centre, Egypt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Research Centre, Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}