Intermittent Fasting Towards Elevated Blood Pressure

March 3, 2023 updated by: Mas Ayu binti Said, University of Malaya

The Effectiveness of Intermittent Fasting Towards Elevated Blood Pressure Among Civil Servants in Aceh

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Aceh
      • Banda Aceh, Aceh, Indonesia
        • Aceh Governor's Office and Aceh Besar regency secretariat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline, 12 weeks and 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline, 12 weeks and 24 weeks
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)
Baseline, 12 weeks and 24 weeks
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)
Baseline, 12 weeks and 24 weeks
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.
Baseline, 12 weeks and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Collaborators

University of Muhammadiyah Aceh

Investigators

  • Principal Investigator: Mas Ayu Said, MPH, PhD, University of Malaya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2021

Primary Completion (Actual)

March 13, 2022

Study Completion (Actual)

March 13, 2022

Study Registration Dates

First Submitted

June 15, 2021

First Submitted That Met QC Criteria

June 27, 2021

First Posted (Actual)

July 8, 2021

Study Record Updates

Last Update Posted (Estimate)

March 6, 2023

Last Update Submitted That Met QC Criteria

March 3, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Intermittent Fasting

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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