Efficacy and Feasibility of Time-restricted Eating on Cardiometabolic Health in Adults With Overweight/Obesity

NCT05310721 | Completed

• 1 other identifier: EXTREME
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 2

Brief Summary

In Spain, obesity epidemic is one of the leading contributors of chronic disease and disability. Obesity is associated with higher morbidity and all-cause mortality risk especially when fat is stored in the abdominal area (i.e., increased visceral adipose tissue, VAT). Although current approaches such as energy restriction may be effective at reducing body fat and improving cardiometabolic health, their long-term adherences are limited. Time-restricted eating (TRE; e.g., 8 hours eating: 16 hours fasting on a daily basis) is a recently emerged intermittent fasting approach with promising cardiovascular benefits. Results from pioneering pilot studies in humans are promising and suggest that simply reducing the eating time window from ≥12 to ≤8-10 hours/day improves cardiometabolic health. However, currently, there is no consensus regarding whether the TRE eating window should be aligned to the early or middle to late part of the day. The EXTREME study will investigate the efficacy and feasibility of three different 8 hours TRE schedules (i.e., early, late and self-selected) over 12 weeks on VAT (main outcome) and cardiometabolic risk factors (secondary outcomes) in adults with overweight/obesity and abdominal obesity. The final goal of the EXTREME study is to demonstrate the health benefits of a novel and pragmatic intervention for the treatment of obesity and related cardiometabolic risk factors; an approach readily adaptable to real-world practice settings, easy for clinicians to deliver, and intuitive for patients to implement and maintain in their lives.

Conditions

Time Restricted Feeding; Obesity, Abdominal; Cardiometabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in visceral adipose tissue

  Visceral adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)

  Change from baseline to 12 weeks

Secondary Outcomes (37)

• Change in Hepatic fat content

  Change from baseline to 12 weeks

• Change in Pancreatic fat content

  Change from baseline to 12 weeks

• Change in Intramuscular fat content

  Change from baseline to 12 weeks

• Change in Hepatic elasticity

  Change from baseline to 12 weeks

• Change in Pancreatic elasticity

  Change from baseline to 12 weeks

Other Outcomes (1)

• Epigenetic changes in clock genes

  Change from baseline to 12 weeks

Study Arms (4)

Early time-restricted eating

EXPERIMENTAL

Participants will eat ad libitum within an 8-hour early eating window. The first meal will be before 10 am (last meal before 18h). No calorie-containing food or beverage intake will be allowed outside the 8-hour eating window. Participants will also receive standard recommendations on healthy lifestyle based on Mediterranean dietary pattern and physical activity recommendations for weight loss and health promotion

Behavioral: Early time-restricted eating

Late time-restricted eating

EXPERIMENTAL

Participants will eat ad libitum within an 8-hour late eating window. The first meal will be at 13h or later (last meal not before 21h). No calorie-containing food or beverage intake will be allowed outside the 8-hour eating window. Participants will also receive standard recommendations on healthy lifestyle based on Mediterranean dietary pattern and physical activity recommendations for weight loss and health promotion

Behavioral: Late time-restricted eating

Self-selected time-restricted eating

EXPERIMENTAL

Participants will self-selecte an 8-hour eating window to eat ad libitum. No calorie-containing food or beverage intake will be allowed outside the 8-hour eating window. Participants will also receive standard recommendations on healthy lifestyle based on Mediterranean dietary pattern and physical activity recommendations for weight loss and health promotion

Behavioral: Self-selected time-restricted eating

Usual-care group

NO INTERVENTION

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

Interventions

Early time-restricted eating BEHAVIORAL

Participants will eat ad libitum within an 8-hour early eating window starting not later than 10am. No calorie-containing food or beverage intake will be allowed outside the 8-hour eating window. Participants will also receive standard recommendations on healthy lifestyle based on Mediterranean dietary pattern and physical activity recommendations for weight loss and health promotion

Early time-restricted eating

Late time-restricted eating BEHAVIORAL

Participants will eat ad libitum within an 8-hour late eating window starting not earlier than 1pm. No calorie-containing food or beverage intake will be allowed outside the 8-hour eating window. Participants will also receive standard recommendations on healthy lifestyle based on Mediterranean dietary pattern and physical activity recommendations for weight loss and health promotion

Late time-restricted eating

Self-selected time-restricted eating BEHAVIORAL

Participants will self-selected an 8-hour eating window to eat ad libitum. No calorie-containing food or beverage intake will be allowed outside the 8-hour eating window. Participants will also receive standard recommendations on healthy lifestyle based on Mediterranean dietary pattern and physical activity recommendations for weight loss and health promotion

Self-selected time-restricted eating

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 30-60 years.
• Body mass index ≥25.0 and \<40 kg/m2
• Weight stability (within 3% of screening weight) for \>3 months prior to study entry.
• Sedentary lifestyle (\<150 min/week of moderate-vigorous intensity exercise) for \>3 months prior to study entry.
• Habitual eating window ≥12 hours.
• At least one of the following metabolic impairments:
• High-density lipoprotein (HDL) cholesterol concentration \<50 mg/dL for females and \<40 mg/dL for males.
• Low-density lipoprotein (LDL) cholesterol levels \>100 mg/dL (or on medication to treat elevated LDL cholesterol levels).
• Serum triglycerides concentration ≥150 mg/dL or on medication to treat elevated triglycerides.
• Systolic blood pressure \>130 mm Hg and/or diastolic blood pressure \>85 mm Hg or already being treated with anti-hypertension medications.
• Impaired glucose tolerance is defined as at least one of the following:
• Fasting plasma glucose (PG) \>100 mg/dL and \<125 mg/dL.
• Hemoglobin A1c between ≥5.7% and \<6.5%.
• Insulin resistance as measured by the Homeostatic Model Assessment of Insulin Resistance (HOMA2-IR) \>1.8.

You may not qualify if:

• 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 or a weight-management program.
• 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.

Sponsors & Collaborators

• Universidad de Granada: lead
• Universidad Pública de Navarra: collaborator

Study Sites (2)

Universidad Pública de Navarra

Pamplona, Navarre, 31006, Spain

Location

University of Granada

Granada, 18011, Spain

Location

Related Publications (2)

• Clavero-Jimeno A, Dote-Montero M, Migueles JH, Camacho-Cardenosa A, Medrano M, Alfaro-Magallanes VM, Oses M, Carneiro-Barrera A, de Cabo R, Munoz-Torres M, Labayen I, Ruiz JR. Time-Restricted Eating and Sleep, Mood, and Quality of Life in Adults With Overweight or Obesity: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2517268. doi: 10.1001/jamanetworkopen.2025.17268.

  PMID: 40560588 DERIVED

• Dote-Montero M, Clavero-Jimeno A, Merchan-Ramirez E, Oses M, Echarte J, Camacho-Cardenosa A, Concepcion M, Amaro-Gahete FJ, Alcantara JMA, Lopez-Vazquez A, Cupeiro R, Migueles JH, De-la-O A, Garcia Perez PV, Contreras-Bolivar V, Munoz-Garach A, Zugasti A, Petrina E, Alvarez de Eulate N, Goni E, Armendariz-Brugos C, Gonzalez Cejudo MT, Martin-Rodriguez JL, Idoate F, Cabeza R, Carneiro-Barrera A, de Cabo R, Munoz-Torres M, Labayen I, Ruiz JR. Effects of early, late and self-selected time-restricted eating on visceral adipose tissue and cardiometabolic health in participants with overweight or obesity: a randomized controlled trial. Nat Med. 2025 Feb;31(2):524-533. doi: 10.1038/s41591-024-03375-y. Epub 2025 Jan 7.

  PMID: 39775037 DERIVED

MeSH Terms

Conditions

Intermittent Fasting; Obesity, Abdominal; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Jonatan R. Ruiz, PhD

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: April 5, 2022
• Study Start: April 11, 2022
• Primary Completion: March 6, 2023
• Study Completion: March 6, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)