NCT07181655 The Effectiveness of Intermittent Fasting, Caloric Restriction and Physical Activity On Metabolic Syndrome
| NCT ID | NCT07181655 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universiti Putra Malaysia |
| Condition | Metabolic Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2025-04-01 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Hazizi Abu Saad, PhD
STUDY DIRECTOR
Universiti Putra Malaysia, 43400 Serdang, Selangor, Malaysia
Frequently Asked Questions
Who can join the NCT07181655 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Metabolic Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07181655 currently recruiting?
Yes, NCT07181655 is actively recruiting participants. Contact the research team at drlamiasalem2024@gmail.com for enrollment information.
Where is the NCT07181655 trial being conducted?
This trial is being conducted at Serdang, Malaysia.
Who is sponsoring the NCT07181655 clinical trial?
NCT07181655 is sponsored by Universiti Putra Malaysia. The principal investigator is Hazizi Abu Saad, PhD at Universiti Putra Malaysia, 43400 Serdang, Selangor, Malaysia. The trial plans to enroll 140 participants.