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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2027-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial (RCT)

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Modified Intermittent Fasting

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

Group Type OTHER

Modified Intermittent Fasting

Intervention Type 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.

Control group: No Intervention

A control group receiving standard care provided by hospital

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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, 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.

Intervention Type OTHER

Other Intervention Names

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Intervention Group

Eligibility Criteria

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Inclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No