The Effectiveness of Intermittent Fasting, Caloric Restriction and Physical Activity On Metabolic Syndrome

NCT07181655 | Recruiting

• 1 other identifier: UPM-PhD LALMAZID
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Metabolic syndrome (MetS) is a global health issue defined by a cluster of risk factors-abdominal obesity, elevated blood pressure, high fasting blood sugar, high triglycerides, and low HDL cholesterol-that together significantly increase the risk of cardiovascular disease, type 2 diabetes, and overall mortality. Globally, about 20-25% of adults are affected, but prevalence varies by region and population; in Saudi Arabia, studies report rates ranging from 28.3% to 56.4%, with higher rates observed in northern and central regions and among men. Major contributors to MetS in Saudi Arabia include obesity, sedentary lifestyle, smoking, and poor dietary habits, such as low fruit consumption. Effective management strategies focus on weight loss through caloric restriction, intermittent fasting, and increased physical activity, all of which have demonstrated improvements in metabolic markers like insulin sensitivity, blood pressure, and lipid profiles. Despite international evidence supporting these interventions, no randomized controlled trials have yet evaluated the combined effects of these approaches on MetS biomarkers in Saudi adults, underscoring the need for targeted research and public health initiatives to address the high and regionally variable burden of MetS in the country.

Conditions

Metabolic Syndrome

Keywords

metabolic syndrome; MetS

Outcome Measures

Primary Outcomes (6)

• Change in Blood Glucose Levels

  Fasting plasma glucose and Random blood glucose will be measured using a spectrophotometer. The normal range of the Fasting plasma glucose is (5.6 - 6.9 mmol/l) and for Random blood glucose is (7.8-11.0 mmol/l).

  Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 4 (4-week post 1 intervention). Timepoint 3 = week 8 (4-week post 2 intervention).Timepoint 4 = week 12 (12-week post 3 intervention

• Change in cholesterol Levels

  Total cholesterol includes both High density lipoprotein cholesterol (HDL) and Low density lipoprotein cholesterol (LDL) will be measured using a spectrophotometer. The normal range of the total cholesterol is (≤ 5.2 mmol/l). While the normal range of LDL-cholesterol is (# 2.6 mmol/l) and HDL-cholesterol is (# 1.3 mmol/l)

  Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 4 (4-week post 1 intervention). Timepoint 3 = week 8 (4-week post 2 intervention).Timepoint 4 = week 12 (12-week post 3 intervention

• Change in Blood Pressure

  Blood pressure will be measured using sphygmomanometer. Normal blood pressure is usually considered to be between 120/80 mmHg.

  Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 4 (4-week post 1 intervention). Timepoint 3 = week 8 (4-week post 2 intervention).Timepoint 4 = week 12 (12-week post 3 intervention

• Change the Body mass index (BMI)

  The Body mass index (BMI) will be report in kg/m\^2 by using the following formula (BMI = kg/m2 where kg is a

  Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 4 (4-week post 1 intervention). Timepoint 3 = week 8 (4-week post 2 intervention).Timepoint 4 = week 12 (12-week post 3 intervention

• Change in physical activity

  Physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ), where time spent on various activity types was summed to determine weekly totals, and frequency, duration, and intensity were converted into metabolic equivalent (MET) values using standard tables

  Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 4 (4-week post 1 intervention). Timepoint 3 = week 8 (4-week post 2 intervention).Timepoint 4 = week 12 (12-week post 3 intervention

• Change in dietary intakes

  The dietary recall method will be implemented twice a week (Fridays and Mondays) to evaluate participants' food intake. The use of the FFQ of MetS (Phase 2) is essential as an effective intervention tool to support the health plan.two non-consecutive days (one usual day and one weekend day).

  Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 4 (4-week post 1 intervention). Timepoint 3 = week 8 (4-week post 2 intervention).Timepoint 4 = week 12 (12-week post 3 intervention

Secondary Outcomes (1)

• Change in sleep quality

  Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 4 (4-week post 1 intervention). Timepoint 3 = week 8 (4-week post 2 intervention).Timepoint 4 = week 12 (12-week post 3 intervention

Study Arms (2)

Modified Intermittent Fasting

OTHER

Intervention program of modified Intermittent fasting (Intermittent fasting, caloric restriction and physical activity)

Other: Modified Intermittent Fasting

Control group: No Intervention

NO INTERVENTION

A control group receiving standard care provided by hospital

Interventions

Modified Intermittent Fasting OTHER

Participants in Intervention group will follow a structured intermittent fasting protocol, specifically the 16:8 method, where they fast for 16 consecutive hours each day and restrict their eating to an 8-hour window. The fasting period can be personalized to suit individual schedules. During these fasting hours, participants must abstain from all foods and caloric drinks, but are encouraged to stay hydrated with non-caloric beverages and they will follow a structured, calorie-restricted diet, tailored to them, using a developed Food Frequency Questionnaire tool to select their daily calorie intake across sections to identify appropriate foods and beverages for patients with metabolic conditions. They will be prescribed to engage in at least 150 minutes per week of moderate intensity aerobic activities, such as brisk walking will be measured and evaluated using the mobile application of physical activity recommended by the Ministry of Health in Saudi Arabia.

Also known as: Intervention Group

Modified Intermittent Fasting

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Abdominal obesity.
• Elevated triglycerides.
• Low HDL cholesterol.
• Elevated blood pressure.
• Elevated fasting blood glucose.

You may not qualify if:

• Being pregnant, lactating women.
• Diagnosis of cardiac failure or/and severe renal or liver diseases, cancer.
• Having had bariatric surgery.
• Physical or mental disability.
• Neurological or cognitive impairment.
• Participant with severely impaired vision, hearing, or speech.
• Following a special diet or having changed their dietary pattern within the previous 12 weeks of the study's start date.
• Use of insulin or sulphonamide derivative oral antidiabetic drugs.
• Conditions that will seriously affect weight management such as having had bariatric surgery.

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

Study Sites (1)

Associate Professor Dr. Hazizi Abu Saad

Serdang, Selangor, 43300, Malaysia

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Hazizi Abu Saad, PhD

  Universiti Putra Malaysia, 43400 Serdang, Selangor, Malaysia

  STUDY DIRECTOR

Central Study Contacts

Lamia Salem Almazid, Master

CONTACT

+601161519002; drlamiasalem2024@gmail.com

Hazizi Abu Saad, PhD

CONTACT

+60397692434; hazizi@upm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Trial (RCT)

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 18, 2025
• Study Start: April 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 30, 2027
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)