Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT05811702
Status:
UNKNOWN
Last Update Posted:
2023-06-12
First Post:
2023-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of High-Fat Ketogenic Diet and Low-Fat Diet in Women Body Weight
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-09', 'studyFirstSubmitDate': '2023-03-07', 'studyFirstSubmitQcDate': '2023-03-31', 'lastUpdatePostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body weight (kg) and BMI', 'timeFrame': '12 weeks', 'description': 'primary outcome of this study to investigated the effective diets HFKD and LFD on reduction of body weight, the percentage of body fat,'}, {'measure': 'percentage of body fat', 'timeFrame': '12 weeks', 'description': 'Primary outcome of this study to investigated the effective diets HFKD and LFD on reduction of percentage of body fat,'}], 'secondaryOutcomes': [{'measure': 'Total Cholesterol mg/dl', 'timeFrame': '12 weeks', 'description': 'Secondary outcome of this study to investigated the effective diets HFKD and LFD on total Cholesterol mg/dl'}, {'measure': 'Triglycerides) mg/dl (', 'timeFrame': '12 weeks', 'description': 'Secondary outcome of this study to investigated the effective diets HFKD and LFD on total Triglycerides) mg/dl ('}, {'measure': 'HDL) mg/dl (', 'timeFrame': '12 weeks', 'description': 'HDL) mg/dl ('}, {'measure': 'LDL) mg/dl (', 'timeFrame': '12 weeks', 'description': 'LDL) mg/dl ('}, {'measure': 'Glucose (mg/dl)', 'timeFrame': '12 weeks', 'description': 'Glucose (mg/dl)'}, {'measure': 'Hb Aic (%)', 'timeFrame': '12 weeks', 'description': 'Hb Aic (%)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight and Obesity', 'Healthy']}, 'descriptionModule': {'briefSummary': 'The aim of this study is investigated the effect of high fat Ketogenic Diet (HFKD) in weight reduction compared to the low-fat diet (LFD) among Saudi overweight and obese women. A randomized acute controlled trial of twenty-eight healthy overweight or obese women in Saudi Arabia, aged between 18 and 40 with a body mass index between 25 and 34.5 kg m2 and fat parentage above 30% . The participants have followed ether HFKD or LFD for 12 weeks.', 'detailedDescription': 'Obesity is associated with an increased risk of high blood pressure and heart muscle damage, which leads to cases that increase the chances of developing cardiovascular diseases, and if weight gain is not controlled, these results lead to obesity is the main cause of cardiovascular disease and causes dyslipidemia, high blood pressure and diabetes. Recently, there have been followed systems and programs food some of which are beneficial for health and some of them are unhealthy systems. The diet is one of the most controversial issues. The aim of this study is investigated the effect of high fat Ketogenic Diet (HFKD) in weight reduction compared to the low-fat diet (LFD) among Saudi overweight and obese women. A randomized acute controlled trial of twenty-eight healthy overweight or obese women in Saudi Arabia, aged between 18 and 40 with a body mass index between 25 and 34.5 kg m2 and fat parentage above 30% . The participants have followed ether HFKD or LFD for 12 weeks. Our primary outcome of this study to investigated the effective diets HFKD and LFD on reduction of body weight, the percentage of body fat, The secondary outcomes have evaluated at the percentage of body fat, blood glucose, lipid profile.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'A randomized acute controlled trial of twenty-eight healthy overweight or obese women in Saudi Arabia, aged between 18 and 40 with a body mass index between 25 and 34.5 kg m2 and fat parentage above 30%', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Overwight and obese wonen\n* aged 18 and 40\n* BMI 25 and 34.5 kg m2\n* fat parentage above 30% .\n\nExclusion Criteria:\n\n* Man\n* women in normal weight or BMI less than 25 and 34.5 kg m2\n* Breastfeeding and pregnant women'}, 'identificationModule': {'nctId': 'NCT05811702', 'briefTitle': 'The Impact of High-Fat Ketogenic Diet and Low-Fat Diet in Women Body Weight', 'organization': {'class': 'OTHER', 'fullName': 'King Faisal University'}, 'officialTitle': 'The Impact of High-Fat Ketogenic Diet and Low-Fat Diet in the Body Weight and Cardiovascular Risk Factors on Overweight and Obese Saudi Women: A Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'KingFaisalU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High fat Ketogenic Diet (HFKD)', 'description': 'A randomized acute controlled trial of twenty-eight healthy overweight or obese women in Saudi Arabia, aged between 18 and 40 with a body mass index between 25 and 34.5 kg m2 and fat parentage above 30% . The participants have followed ether HFKD for 12 weeks. The weight will be measured weekly, body fat % and blood samples before and after 12 weeks of following HFKD.', 'interventionNames': ['Other: A randomized acute controlled trial of twenty-eight healthy overweight or obese women']}, {'type': 'EXPERIMENTAL', 'label': 'low-fat diet (LFD', 'description': 'A randomised acute controlled trial of twenty-eight healthy overweight or obese women in Saudi Arabia, aged between 18 and 40 with a body mass index between 25 and 34.5 kg m2 and fat parentage above 30% . The participants have followed ether LFD for 12 weeks. The weight will be measured weekly, body fat % and blood samples before and after 12 weeks of following LFD.', 'interventionNames': ['Other: A randomized acute controlled trial of twenty-eight healthy overweight or obese women']}], 'interventions': [{'name': 'A randomized acute controlled trial of twenty-eight healthy overweight or obese women', 'type': 'OTHER', 'description': 'A randomized acute controlled trial of twenty-eight healthy overweight or obese women in Saudi Arabia, aged between 18 and 40 with a body mass index between 25 and 34.5 kg m2 and fat parentage above 30% . The participants have followed ether HFKD or LFD for 12 weeks. Our primary outcome of this study to investigated the effective diets HFKD and LFD on reduction of body weight, the percentage of body fat', 'armGroupLabels': ['High fat Ketogenic Diet (HFKD)', 'low-fat diet (LFD']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Riyadh', 'status': 'RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'name': 'Randah Alqurashi, PhD', 'role': 'CONTACT', 'email': 'ralqurashi@kfu.edu.sa', 'phone': '00966559223608'}, {'name': 'Atheer Alnobi, MSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Randah Alqurashi', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'centralContacts': [{'name': 'Randah Alqurashi, PhD', 'role': 'CONTACT', 'email': 'ralqurashi@kfu.edu.sa', 'phone': '00966559223608'}, {'name': 'Atheer Alnobi, MSc', 'role': 'CONTACT', 'email': 'randooo-12@hotmail.com', 'phone': '009665059599'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Faisal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Randah Miqbil Alqurashi', 'investigatorAffiliation': 'King Faisal University'}}}}