Intermittent fasting with calorie restriction and exercise for adults with metabolic syndrome

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

This program will test whether combining intermittent fasting, reduced calories, and increased physical activity helps adults with metabolic syndrome improve blood sugar, blood pressure, cholesterol, and weight.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Universiti Putra Malaysia (Academic / other)
• Locations: 1 site (Serdang, Selangor)
• Trial ID: NCT07181655 on ClinicalTrials.gov

What this trial studies

This randomized controlled trial will assign 140 adults with metabolic syndrome to either a modified intermittent fasting program combining caloric restriction and promoted physical activity or to standard hospital care. Participants will be followed before and after the intervention to measure changes in glycemic control (fasting glucose, HbA1c), blood pressure, lipid profile, weight, BMI, and waist circumference, as well as physical activity, sleep quality, and dietary intake. The intervention arm uses a combined behavioral approach (timed eating with calorie targets plus increased physical activity) while the control arm receives usual care. Outcomes will be compared between groups to determine whether the combined lifestyle approach produces greater improvements in metabolic syndrome biomarkers and body composition.

Who should consider this trial

Good fit: Adults aged 18 or older who meet criteria for metabolic syndrome (three or more of abdominal obesity, high triglycerides, low HDL, elevated blood pressure, or elevated fasting glucose) and who can attend clinic visits are ideal candidates.

Not a fit: People who are pregnant or lactating, have severe heart, kidney, or liver disease, recent bariatric surgery, major cognitive or physical disabilities, or who use insulin or certain oral antidiabetic drugs are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the program could help people with metabolic syndrome lower blood sugar and cardiovascular risk factors and lose weight through achievable lifestyle changes.

How similar studies have performed: Prior research has shown that intermittent fasting, caloric restriction, and increased physical activity can improve metabolic markers individually and in combination, though results vary by population and intervention design.

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.

Where this trial is running

Serdang, Selangor

• Associate Professor Dr. Hazizi Abu Saad — Serdang, Selangor, Malaysia (Recruiting)

Study contacts

• Study coordinator: Lamia Salem Almazid, Master

Conditions Metabolic Syndrome; metabolic syndrome; MetS