Time-Restricted Eating, Exercise and Cardiometabolic Health in Obesity (TEMPUS)

University of Granada (UGR)

Status: Active, not recruiting

Conditions: Cardiometabolic Syndrome; Obesity; Time Restricted Feeding; Hepatic Steatosis; Exercise

Treatments: Behavioral: Time-restricted eating plus exercise intervention; Behavioral: Time-restricted eating intervention; Behavioral: Exercise intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05897073

TEMPUS

Details and patient eligibility

About

In Spain, overweight and obesity prevalence is reaching 70% in men and 50% in women. Excess of triglycerides are usually stored in the subcutaneous adipose tissue (SAT), until a point where SAT is unable to expand further. Therefore, lipids are deposited in visceral and other peripheral organs and tissues that are not otherwise designed for adipose storage such as the liver, pancreas or the skeletal muscle, a process known as ectopic fat deposition. "Time-restricted eating" (TRE) is a recently emerged intermittent fasting approach which has the potential to maximize the beneficial metabolic effects extensively reported for energy intake restriction. Furthermore, exercise reduces hepatic steatosis and improves cardiometabolic health in humans. However, whether the effects of TRE combined with exercise on reducing hepatic steatosis are superior to TRE or exercise intervention alone remains unknown. The TEMPUS study will investigate the effects of a 12-week TRE combined with supervised exercise intervention, as compared with TRE or exercise alone, and usual-care control group, on hepatic fat (primary outcome) and cardiometabolic health (secondary outcomes) in adults with obesity; and to unveil the role of gut microbiota.

Enrollment: 184 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged 25-65 years.
• Body mass index ≥28.0 and <40.0 kg/m2.
• Weight stability (within 5% of screening weight) for >3 months prior to study entry.
• Habitual eating window ≥11 hours.

Exclusion criteria

• History of a major adverse cardiovascular event, clinically significant kidney, endocrine, or neurological disease, bariatric surgery, HIV/AIDS, known inflammatory and/or rheumatologic disease, cancer, or other medical condition in which fasting or exercise is contraindicated.
• Type 1 or Type 2 diabetes.
• Major psychiatric disorders, eating disorders, sleep disorders, or alcohol abuse.
• Regular use of medication or compounds that may affect study outcomes (e.g., antidiabetic, steroids, beta-blockers, antibiotics, prebiotics, probiotics and symbiotics).
• Participating in a weight loss, a weight-management program or a supervised exercise program (more than 30 minutes three times per week, or 45 minutes twice a week, moderate/vigorous intensity).
• Pregnancy and lactation or planned pregnancy (within the study period).
• Caregiver for a dependent requiring frequent nocturnal care/sleep interruptions. Shift workers with variable hours (e.g., nocturnal).
• Frequent travel over time zones during the study period.
• Fear of needles and claustrophobia to magnetic resonance imaging (MRI).
• Being unable to understand and to accept the instructions or the study objectives and protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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184 participants in 4 patient groups

Time-restricted eating intervention

Experimental group

Description:

Participants will be asked to reduce their daily eating time window to a maximum of 8 hours/day. They can choose when to begin their eating window but will be advised that the last meal should be completed before or at 20:00 hours. No calorie-containing food or beverage intake will be allowed outside the 8 hours eating window.

Treatment:

Behavioral: Time-restricted eating intervention

Supervised exercise intervention

Experimental group

Description:

The exercise intervention will include 2 days/week of supervised moderate-high intensity resistance training (rating perceived exertion \>7, circuit-training, upper and lower body exercises involving major muscle groups) and high-intensity interval training (4 sets of 4-minute intervals at \>85% peak heat rate with 4-minute of active recovery at 50-65% peak heat rate, uphill treadmill walking). Moreover, participants will receive an individualized moderate-intensity goal-setting aerobic (walking) program consisting of increasing 15% daily steps per week.

Treatment:

Behavioral: Exercise intervention

Usual-care control group

No Intervention group

Description:

Participants will receive standard recommendations on healthy lifestyle based on Mediterranean dietary pattern and physical activity recommendations for weight loss and health promotion.

Time-restricted eating plus Supervised exercise

Experimental group

Description:

Participants will be asked to reduce their daily eating time window to a maximum of 8 hours/day. They can choose when to begin their eating window but will be advised that the last meal should be completed before or at 20:00 hours. No calorie-containing food or beverage intake will be allowed outside the 8 hours eating window. The exercise intervention will include 2 days/week of supervised moderate-high intensity resistance training (rating perceived exertion \>7, circuit-training, upper and lower body exercises involving major muscle groups) and high-intensity interval training (4 sets of 4-minute intervals at \>85% peak heat rate with 4-minute of active recovery at 50-65% peak heat rate, uphill treadmill walking). Moreover, participants will receive an individualized moderate-intensity goal-

Treatment:

Behavioral: Time-restricted eating plus exercise intervention