Clinical trial NCT05310721: Efficacy and Feasibility of Time-restricted Eating on Cardiometabolic Health in Adults With Overweight/Obesity
Official title: Efficacy and Feasibility of Time-restricted Eating on Cardiometabolic Health in Adults With Overweight/Obesity: The EXTREME Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Time Restricted Feeding
Obesity, Abdominal
Cardiometabolic Syndrome
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: Universidad Pública de Navarra
First posted: 2022-04-05
Enrollment: 197
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

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 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.

Primary outcomes:
measure: Change in visceral adipose tissue
timeFrame: Change from baseline to 12 weeks
Secondary outcomes:
measure: Change in Hepatic fat content
timeFrame: Change from baseline to 12 weeks
measure: Change in Pancreatic fat content
timeFrame: Change from baseline to 12 weeks
measure: Change in Intramuscular fat content
timeFrame: Change from baseline to 12 weeks
measure: Change in Hepatic elasticity
timeFrame: Change from baseline to 12 weeks
measure: Change in Pancreatic elasticity
timeFrame: Change from baseline to 12 weeks
measure: Change in Fasting glucose metabolism
timeFrame: Change from baseline to 12 weeks
measure: Change in Fasting lipid metabolism
timeFrame: Change from baseline to 12 weeks
measure: Change in Inflammatory profile
timeFrame: Change from baseline to 12 weeks
measure: Change in Hepatic profile
timeFrame: Change from baseline to 12 weeks
measure: Change in Kidney profile
timeFrame: Change from baseline to 12 weeks
measure: Change in Glycemia (Continuous Glucose Monitoring)
timeFrame: Change from baseline to 12 weeks
measure: Change in Body weight
timeFrame: Change from baseline to 12 weeks
measure: Change in Body composition (Fat mass and fat free mass)
timeFrame: Change from baseline to 12 weeks
measure: Change in Anthropometric measures
timeFrame: Change from baseline to 12 weeks
measure: Change in Blood pressure
timeFrame: Change from baseline to 12 weeks
measure: Change in energy intake
timeFrame: Change from baseline to 12 weeks
measure: Change in macronutrients intake
timeFrame: Change from baseline to 12 weeks
measure: Change in dietary habits
timeFrame: Change from baseline to 12 weeks
measure: Change in Food craving
timeFrame: Change from baseline to 12 weeks
measure: Change in Appetitive traits
timeFrame: Change from baseline to 12 weeks
measure: Change in Subjective sleep quality
timeFrame: Change from baseline to 12 weeks
measure: Change in Objectively sleep quality
timeFrame: Change from baseline to 12 weeks
measure: Change in Chronotype
timeFrame: Change from baseline to 12 weeks
measure: Change in Morning-Evening type
timeFrame: Change from baseline to 12 weeks
measure: Change Subjective physical activity levels
timeFrame: Change from baseline to 12 weeks
measure: Change Objectively physical activity levels
timeFrame: Change from baseline to 12 weeks
measure: Change in Depression aspects
timeFrame: Change from baseline to 12 weeks
measure: Change in Stress aspects
timeFrame: Change from baseline to 12 weeks
measure: Change in Anxiety aspects
timeFrame: Change from baseline to 12 weeks
measure: Change in General health
timeFrame: Change from baseline to 12 weeks
measure: Change in Quality of life
timeFrame: Change from baseline to 12 weeks
measure: Change in Gut microbiota composition
timeFrame: Change from baseline to 12 weeks
measure: Change in Gut microbiota diversity
timeFrame: Change from baseline to 12 weeks
measure: Feasibility of recruitment
timeFrame: 12 weeks
measure: Feasibility of the intervention
timeFrame: 12 weeks
measure: Adherence to the intervention
timeFrame: Every day during the intervention, up to 90 days
measure: Genetic variants in Clock genes
timeFrame: Baseline
Other outcomes:
measure: Epigenetic changes in clock genes
timeFrame: Change from baseline to 12 weeks
Locations:
city: Pamplona
country: Spain
facility: Universidad Pública de Navarra
state: Navarra
city: Granada
country: Spain
facility: University of Granada
Study officials:
affiliation: Universidad de Granada
name: Jonatan R. Ruiz, PhD
role: PRINCIPAL_INVESTIGATOR
References: