Intermittent Fasting Towards Elevated Blood Pressure

NCT04953650 | Completed

• 1 other identifier: Intermittent Fasting
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Intermittent Fasting; Elevated Blood Pressure

Keywords

fasting; intermittent fasting; 5:2 diet; blood pressure; body mass index; body weight; waist circummference; calorie intake

Outcome Measures

Primary Outcomes (1)

• Blood pressure

  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 Outcomes (4)

• Body weight

  Baseline, 12 weeks and 24 weeks

• Body mass index

  Baseline, 12 weeks and 24 weeks

• Waist circumference

  Baseline, 12 weeks and 24 weeks

• Calorie intake

  Baseline, 12 weeks and 24 weeks

Study Arms (2)

intervention group

EXPERIMENTAL

two fasting days and five ad-libitum days followed by usual exercise.

Behavioral: Intermittent fasting

Control group

SHAM COMPARATOR

Usual diet and usual exercise prior to the intervention.

Other: No intervention

Interventions

Intermittent fasting BEHAVIORAL

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.

intervention group

No intervention OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Malaya: lead
• University of Muhammadiyah Aceh: collaborator

Study Sites (1)

Aceh Governor's Office and Aceh Besar regency secretariat

Banda Aceh, Special Region of Aceh, Indonesia

Location

Related Publications (12)

• 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: 28862406 BACKGROUND

• 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: 27687887 BACKGROUND

• 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: 31151228 BACKGROUND

• 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: 25251676 BACKGROUND

• 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: 28272343 BACKGROUND

• 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: 31294789 BACKGROUND

• 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: 30142886 BACKGROUND

• 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: 30354655 RESULT

• 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: 29754952 RESULT

• 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: 29778565 RESULT

• 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: 23408502 RESULT

• 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.

  PMID: 38013523 DERIVED

MeSH Terms

Conditions

Intermittent Fasting; Hypertension; Fasting; Body Weight

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mas Ayu Said, MPH, PhD

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academician

Model Details: 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.

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: July 8, 2021
• Study Start: September 27, 2021
• Primary Completion: March 13, 2022
• Study Completion: March 13, 2022
• Last Updated: March 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)