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Intermittent Fasting Towards Elevated Blood Pressure

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ClinicalTrials.gov Identifier: NCT04953650
Recruitment Status : Not yet recruiting
First Posted : July 8, 2021
Last Update Posted : July 8, 2021
Sponsor:
Collaborator:
University of Muhammadiyah Aceh
Information provided by (Responsible Party):
Mas Ayu binti Said, University of Malaya

Brief Summary:

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.

Like 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.


Condition or disease Intervention/treatment Phase
Intermittent Fasting Elevated Blood Pressure Behavioral: Intermittent fasting Other: No intervention Not Applicable

Detailed Description:

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.

Trial procedure

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Outcomes Assessor)
Masking Description: The enumerators will help the researcher in data measurements; however, they will be blinded for the intervention.
Primary Purpose: Supportive Care
Official Title: The Effectiveness of Intermittent Fasting Towards Elevated Blood Pressure Among Civil Servants in Aceh
Estimated Study Start Date : July 16, 2021
Estimated Primary Completion Date : January 16, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: intervention group
two fasting days and five ad-libitum days followed by usual exercise.
Behavioral: Intermittent fasting
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.

Sham Comparator: Control group
Usual diet and usual exercise prior to the intervention.
Other: No intervention
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.




Primary Outcome Measures :
  1. Blood pressure [ Time Frame: Baseline, 12 weeks and 24 weeks ]

    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.

    The blood pressure is measured by Omron sphygmomanometer (Omron HEM 7130 LP, Kyoto, Japan).



Secondary Outcome Measures :
  1. Body weight [ Time Frame: Baseline, 12 weeks and 24 weeks ]

    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.

    The body weight is measured by weighing scale (Oserio Body fat monitor, Guozhong, Taiwan)


  2. Body mass index [ Time Frame: Baseline, 12 weeks and 24 weeks ]

    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.

    The BMI is measured by weighing scale (Oserio Body fat monitor, Guozhong, Taiwan) and Stadiometer (Saga, Indonesia)


  3. Waist circumference [ Time Frame: Baseline, 12 weeks and 24 weeks ]

    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.

    The waist circumference is measured by tape line (China)


  4. Calorie intake [ Time Frame: Baseline, 12 weeks and 24 weeks ]

    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.

    The calorie intake is measured by three days food record form.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult between 18-60 years with EBP 130-139/85-89 mm Hg;
  2. Overweight and obese with BMI above is equal to 25 kilogram/m2;
  3. Do not have any gastric diseases or problems with the fasting;
  4. Able to read and write;
  5. Willing to sign the inform consent

Exclusion Criteria:

  1. Disability person;
  2. In medication either blood pressure or another disease;
  3. Pregnant woman;
  4. Employees who will be retired in the intervention duration;
  5. Employees who will undergo hajj pilgrimage in the year 2021.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04953650


Contacts
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Contact: Dharina Baharuddin, BPH, MPH +6285260963094 dharinabaharuddin@gmail.com
Contact: Mas Ayu Said, MPH, PhD +60192140616 mas@ummc.edu.my

Locations
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Indonesia
Aceh Governor's Office and Aceh Besar regency secretariat
Banda Aceh, Aceh, Indonesia
Contact: Dharina Baharuddin, MPH    +6285260963094    dharinabaharuddin@gmail.com   
Sponsors and Collaborators
University of Malaya
University of Muhammadiyah Aceh
Investigators
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Principal Investigator: Mas Ayu Said, MPH, PhD University of Malaya
Publications of Results:

Other Publications:

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Responsible Party: Mas Ayu binti Said, Academician, University of Malaya
ClinicalTrials.gov Identifier: NCT04953650    
Other Study ID Numbers: Intermittent Fasting
First Posted: July 8, 2021    Key Record Dates
Last Update Posted: July 8, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mas Ayu binti Said, University of Malaya:
fasting
intermittent fasting
5:2 diet
blood pressure
body mass index
body weight
waist circummference
calorie intake
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases