Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-01-05 @ 2:30 AM
Study NCT ID:
NCT04953650
Status:
COMPLETED
Last Update Posted:
2023-03-06
First Post:
2021-06-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intermittent Fasting Towards Elevated Blood Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000093763', 'term': 'Intermittent Fasting'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D005215', 'term': 'Fasting'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This trial will have two groups; the intervention and the control group. Both groups will receive health education. Hence, the Intervention group will undergo two fasting days within the week from dusk to dawn, while the control group is doing the regular diet. No exercise control for both groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-03-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-03', 'studyFirstSubmitDate': '2021-06-15', 'studyFirstSubmitQcDate': '2021-06-27', 'lastUpdatePostDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'Baseline, 12 weeks and 24 weeks', 'description': 'Change from baseline systolic blood pressure and diastolic blood pressure at 12 weeks and 24 weeks (6 months) in participants with elevated blood pressure and BMI above is equal to 25 kilogram/m2.\n\nThe blood pressure is measured by Omron sphygmomanometer (Omron HEM 7130 LP, Kyoto, Japan).'}], 'secondaryOutcomes': [{'measure': 'Body weight', 'timeFrame': 'Baseline, 12 weeks and 24 weeks', 'description': 'Change from baseline body weight at 12 weeks and 24 weeks (6 months) in participants with elevated blood pressure and BMI above is equal to 25 kilogram/m2.\n\nThe body weight is measured by weighing scale (Oserio Body fat monitor, Guozhong, Taiwan)'}, {'measure': 'Body mass index', 'timeFrame': 'Baseline, 12 weeks and 24 weeks', 'description': 'Change from baseline BMI at 12 weeks and 24 weeks (6 months) in participants with elevated blood pressure and BMI above is equal to 25 kilogram/m2.\n\nThe BMI is measured by weighing scale (Oserio Body fat monitor, Guozhong, Taiwan) and Stadiometer (Saga, Indonesia)'}, {'measure': 'Waist circumference', 'timeFrame': 'Baseline, 12 weeks and 24 weeks', 'description': 'Change from baseline waist circumference at 12 weeks and 24 weeks (6 months) in participants with elevated blood pressure and BMI above is equal to 25 kilogram/m2.\n\nThe waist circumference is measured by tape line (China)'}, {'measure': 'Calorie intake', 'timeFrame': 'Baseline, 12 weeks and 24 weeks', 'description': 'Change from baseline calorie intake at 12 weeks and 24 weeks (6 months) in participants with elevated blood pressure and BMI above is equal to 25 kilogram/m2.\n\nThe calorie intake is measured by three days food record form.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fasting', 'intermittent fasting', '5:2 diet', 'blood pressure', 'body mass index', 'body weight', 'waist circummference', 'calorie intake'], 'conditions': ['Intermittent Fasting', 'Elevated Blood Pressure']}, 'referencesModule': {'references': [{'pmid': '28862406', 'type': 'BACKGROUND', 'citation': 'Allaert FA. Effect of NaCl + Chitosan 3% vs. NaCl on high blood pressure parameters of healthy volunteers with prehypertension. Minerva Cardioangiol. 2017 Dec;65(6):563-576. doi: 10.23736/S0026-4725.17.04451-6. Epub 2017 Aug 31.'}, {'pmid': '27687887', 'type': 'BACKGROUND', 'citation': 'Irwan AM, Kato M, Kitaoka K, Ueno E, Tsujiguchi H, Shogenji M. Development of the salt-reduction and efficacy-maintenance program in Indonesia. Nurs Health Sci. 2016 Dec;18(4):519-532. doi: 10.1111/nhs.12305. Epub 2016 Sep 29.'}, {'pmid': '31151228', 'type': 'BACKGROUND', 'citation': 'Jamshed H, Beyl RA, Della Manna DL, Yang ES, Ravussin E, Peterson CM. Early Time-Restricted Feeding Improves 24-Hour Glucose Levels and Affects Markers of the Circadian Clock, Aging, and Autophagy in Humans. Nutrients. 2019 May 30;11(6):1234. doi: 10.3390/nu11061234.'}, {'pmid': '25251676', 'type': 'BACKGROUND', 'citation': 'Hoddy KK, Kroeger CM, Trepanowski JF, Barnosky A, Bhutani S, Varady KA. Meal timing during alternate day fasting: Impact on body weight and cardiovascular disease risk in obese adults. Obesity (Silver Spring). 2014 Dec;22(12):2524-31. doi: 10.1002/oby.20909. Epub 2014 Sep 24.'}, {'pmid': '28272343', 'type': 'BACKGROUND', 'citation': 'Kerr DA, Dhaliwal SS, Pollard CM, Norman R, Wright JL, Harray AJ, Shoneye CL, Solah VA, Hunt WJ, Zhu F, Delp EJ, Boushey CJ. BMI is Associated with the Willingness to Record Diet with a Mobile Food Record among Adults Participating in Dietary Interventions. Nutrients. 2017 Mar 7;9(3):244. doi: 10.3390/nu9030244.'}, {'pmid': '31294789', 'type': 'BACKGROUND', 'citation': 'Kusuma D, Kusumawardani N, Ahsan A, K Sebayang S, Amir V, Ng N. On the verge of a chronic disease epidemic: comprehensive policies and actions are needed in Indonesia. Int Health. 2019 Nov 13;11(6):422-424. doi: 10.1093/inthealth/ihz025.'}, {'pmid': '30142886', 'type': 'BACKGROUND', 'citation': 'Bowen J, Brindal E, James-Martin G, Noakes M. Randomized Trial of a High Protein, Partial Meal Replacement Program with or without Alternate Day Fasting: Similar Effects on Weight Loss, Retention Status, Nutritional, Metabolic, and Behavioral Outcomes. Nutrients. 2018 Aug 23;10(9):1145. doi: 10.3390/nu10091145.'}, {'pmid': '30354655', 'type': 'RESULT', 'citation': 'Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2018 Oct 23;138(17):e426-e483. doi: 10.1161/CIR.0000000000000597. No abstract available.'}, {'pmid': '29754952', 'type': 'RESULT', 'citation': 'Sutton EF, Beyl R, Early KS, Cefalu WT, Ravussin E, Peterson CM. Early Time-Restricted Feeding Improves Insulin Sensitivity, Blood Pressure, and Oxidative Stress Even without Weight Loss in Men with Prediabetes. Cell Metab. 2018 Jun 5;27(6):1212-1221.e3. doi: 10.1016/j.cmet.2018.04.010. Epub 2018 May 10.'}, {'pmid': '29778565', 'type': 'RESULT', 'citation': 'Sundfor TM, Svendsen M, Tonstad S. Effect of intermittent versus continuous energy restriction on weight loss, maintenance and cardiometabolic risk: A randomized 1-year trial. Nutr Metab Cardiovasc Dis. 2018 Jul;28(7):698-706. doi: 10.1016/j.numecd.2018.03.009. Epub 2018 Mar 29.'}, {'pmid': '23408502', 'type': 'RESULT', 'citation': 'Bhutani S, Klempel MC, Kroeger CM, Trepanowski JF, Varady KA. Alternate day fasting and endurance exercise combine to reduce body weight and favorably alter plasma lipids in obese humans. Obesity (Silver Spring). 2013 Jul;21(7):1370-9. doi: 10.1002/oby.20353. Epub 2013 May 29.'}, {'pmid': '38013523', 'type': 'DERIVED', 'citation': 'Baharuddin D, Said MA, Majid HA. Protocol For Intervention Study In Reducing Elevated Blood Pressure Through Intermittent Fasting. J Pak Med Assoc. 2023 Nov;73(11):2171-2176. doi: 10.47391/JPMA.7748.'}]}, 'descriptionModule': {'briefSummary': 'To date, the prevalence of Hypertension (HPT) is getting increase worldwide. This situation is contributed mostly by the Lower-Income Countries (LIC) and Lower-Middle-Income Countries (LMICs) include Asians. Elevated Blood Pressure (EBP) in the early phase is often unrealized before developing to HPT, leading to several diseases in terms of cardiovascular diseases (CVDs). In preventing EBP, the European Society of Cardiology in 2017 classifies blood pressure into three groups; normal, pre-hypertension, and hypertensive crisis. People in the normal phase with the high-normal line are classified into EBP. If this group is determined and controlled, they will further keep in normal blood pressure. Contrarily, they are experiencing the next phase of HPT.\n\nLike other Asian countries, Indonesia was experiencing an extreme prevalence of HPT, and Aceh, which is one of the provinces in Indonesia has a very high prevalence of HPT as well (20% increment from 2013-2018), is estimated to equal to the EBP prevalence. Despite many promotive and preventive interventions confirmed to decrease HPT, early screening has been convinced to recover the HPT in Indonesia. However, the HPT prevalence was examined steadily increasing. Intermittent fasting (IF) is recognized as a new method in decreasing metabolic factors based on several types of research currently. Therefore, the investigators are studying the effectiveness of intermittent fasting on people with EBP. Conducting healthy lifestyle intervention that is inexpensive, doable, and easily accessible, would be a new method for controlling EBP.', 'detailedDescription': "This trial aims to evaluate the effectiveness of three months intermittent fasting intervention followed by three months maintenance phase in stabilizing blood pressure among the EBP group with the high-normal signal. This trial will conducts in Aceh, Indonesia.\n\nTrial procedure\n\n1. In the beginning, the researcher chooses the allocation group for either intervention or control group based on the potential number of workers from each department. Based on that, it was decided that the intervention group is the Governor's office, and the Aceh Besar regency secretariat is the control group.\n2. Letters of permission are submitted to both departments and continued by blood pressure screening once it is approved. Hence, the enumerators will screen all the workers. Each eligible participant (EBP 130-139/85-89 mm Hg and BMI ³ 25 kilograms/m2) will be invited to join blood pressure plus nutrition class on the day after, and fulfill the baseline characteristic questionnaire once they sign the informed consent. During the class, the researcher will describe the study procedure, study objective, process, monitoring, follow-up, methodology, risk and benefit, confidentiality, anonymity, and withdrawal from the study in both groups with the different context of intervention. Because of the covid-19 pandemic, all participants are allocated in a few small groups during baseline training.\n3. The participants will join complete anthropometric measurements and fulfill questions in the STEP instrument and GPAQ instrument. Four enumerators will assist the participants; however, they will be blinded to intervention assignment.\n4. The intervention group will undergo two fasting days and five ad libitum days during the intervention phase and continued to the maintenance phase. Otherwise, the control group will have a usual diet before the trial. Furthermore, both groups will have current exercise.\n5. Calculation of the actual sample size to detect effect size in the primary and secondary objectives of the project has been conducted. Sample selection techniques will be described further in the published paper.\n6. A mixed linear model will be applied to count the intervention effects (blood pressure, body weight, body mass index, waist circumference, and calorie intake), while a generalized estimating equation (GEE) will be used as well for categorical outcomes. Characteristics at baseline will be summarised by each arm using numbers and percentages, means and standard deviations or medians, and inter-quartile ranges where applicable."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult between 18-60 years with EBP 130-139/85-89 mm Hg;\n2. Overweight and obese with BMI above is equal to 25 kilogram/m2;\n3. Do not have any gastric diseases or problems with the fasting;\n4. Able to read and write;\n5. Willing to sign the inform consent\n\nExclusion Criteria:\n\n1. Disability person;\n2. In medication either blood pressure or another disease;\n3. Pregnant woman;\n4. Employees who will be retired in the intervention duration;\n5. Employees who will undergo hajj pilgrimage in the year 2021.'}, 'identificationModule': {'nctId': 'NCT04953650', 'briefTitle': 'Intermittent Fasting Towards Elevated Blood Pressure', 'organization': {'class': 'OTHER', 'fullName': 'University of Malaya'}, 'officialTitle': 'The Effectiveness of Intermittent Fasting Towards Elevated Blood Pressure Among Civil Servants in Aceh', 'orgStudyIdInfo': {'id': 'Intermittent Fasting'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention group', 'description': 'two fasting days and five ad-libitum days followed by usual exercise.', 'interventionNames': ['Behavioral: Intermittent fasting']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'description': 'Usual diet and usual exercise prior to the intervention.', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'Intermittent fasting', 'type': 'BEHAVIORAL', 'description': 'The intervention group is required to perform intermittent fasting for two days. The intermittent fasting method for this group will mimic the Sunnah Muslim fasting; they are allowed to consume food and calorie water without restriction in between dusk and dawn. During the five ad libitum days, they are allowed to have a variety of foods and drinks. Subjects will be informed about healthy food choices; choosing low-fat meat and dairy options, increasing fruit and vegetable intake.', 'armGroupLabels': ['intervention group']}, {'name': 'No intervention', 'type': 'OTHER', 'description': 'The control group will receive education training at the baseline as well, regarding blood pressure and nutrition. They will have usual exercise prior to the intervention. Furthermore, the group will have equal health education through health promotion leaflets which have been issued by the ministry of health.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Banda Aceh', 'state': 'Special Region of Aceh', 'country': 'Indonesia', 'facility': "Aceh Governor's Office and Aceh Besar regency secretariat", 'geoPoint': {'lat': 5.54167, 'lon': 95.33333}}], 'overallOfficials': [{'name': 'Mas Ayu Said, MPH, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Malaya'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaya', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Muhammadiyah Aceh', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Academician', 'investigatorFullName': 'Mas Ayu binti Said', 'investigatorAffiliation': 'University of Malaya'}}}}