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

Official title

The Effectiveness of Intermittent Fasting, Caloric Restriction and Physical Activity Intervention On Metabolic Syndrome Biomarkers Among Adults With Metabolic Syndrome at Hospitals in Riyadh, Saudi Arabia

Overview

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.

Detailed description

This study aims to evaluate the effectiveness of interventions involving intermittent fasting, physical activity, and caloric restriction on metabolic syndrome biomarkers, body composition and lifestyle characteristics among patients with metabolic syndrome in Riyadh, Saudi Arabia. A randomized controlled trial (RCT) will be conducted at two hospitals, with 140 participants randomly assigned to two groups: Intervention Group the participants will be engaged in Intervention program of modified IF (Intermittent fasting, caloric restriction and physical activity) and Control Group: the participants will be engaged standard intervention provided by hospital. The primary outcomes will include changes in glycemic control (fasting blood glucose, HbA1c), cardiovascular risk markers (blood pressure, lipid profile), anthropometric measures (weight, BMI, waist circumference), physical activity levels, sleep quality, and dietary intake, assessed before and after the intervention to determine the comparative effectiveness of each approach on MetS biomarkers.

Interventions

• Other Modified Intermittent Fasting
  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, t

Primary outcome measures

• Change in Blood Glucose Levels [Time frame: 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 [Time frame: 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 [Time frame: 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) [Time frame: 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 [Time frame: 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 [Time frame: 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 outcome measures (1)

• Change in sleep quality [Time frame: 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]

Eligibility criteria

Inclusion criteria

• The inclusion criteria will be adult aged 18 years and above who have three or more of the following five risk factors (Kunduraci \& Ozbek, 2020):

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

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Other

Study locations

Malaysia · 1 center

• Associate Professor Dr. Hazizi Abu Saad — Serdang

Identifiers

NCT: NCT07181655 · UPM-PhD LALMAZID

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗