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Completed

NCT Number: NCT05310721

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

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.

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Key information

Conditions

Time Restricted Feeding Behavior Body Weight Cardiometabolic Syndrome Fasting Feeding Behavior Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Intermittent Fasting Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Pública de Navarra, Pamplona, Navarre, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

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

Primary outcomes

  1. Change in visceral adipose tissue

    Time frame: Change from baseline to 12 weeks

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

Secondary outcomes

  1. Change in Hepatic fat content

    Time frame: Change from baseline to 12 weeks

    Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI)

  2. Change in Pancreatic fat content

    Time frame: Change from baseline to 12 weeks

    Pancreatic fat content will be assessed by Magnetic Resonance Imaging (MRI)

  3. Change in Intramuscular fat content

    Time frame: Change from baseline to 12 weeks

    Intramuscular fat content will be assessed by Magnetic Resonance Imaging (MRI)

  4. Change in Hepatic elasticity

    Time frame: Change from baseline to 12 weeks

    Hepatic elasticity will be assessed by US elastography

  5. Change in Pancreatic elasticity

    Time frame: Change from baseline to 12 weeks

    Pancreatic elasticity will be assessed by US elastography

  6. Change in Fasting glucose metabolism

    Time frame: Change from baseline to 12 weeks

    Fasting blood samples will be used to analyse different biomarkers of glucose metabolism

  7. Change in Fasting lipid metabolism

    Time frame: Change from baseline to 12 weeks

    Fasting blood samples will be used to analyse different biomarkers of lipid metabolism (e.g., triglycerides, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol)

  8. Change in Inflammatory profile

    Time frame: Change from baseline to 12 weeks

    Fasting blood samples will be used to analyse inflammatory profile (e.g., C-reactive protein and interleukin 6)

  9. Change in Hepatic profile

    Time frame: Change from baseline to 12 weeks

    Fasting blood samples will be used to analyse hepatic profile (e.g., alkaline phosphatase, bilirubin, alanine transaminase and gamma-glutamyl transferase)

  10. Change in Kidney profile

    Time frame: Change from baseline to 12 weeks

    Fasting blood samples will be used to analyse kidney profile (e.g., creatinine and creatine kinase)

  11. Change in Glycemia (Continuous Glucose Monitoring)

    Time frame: Change from baseline to 12 weeks

    Glycemia will be assessed by Continuous Glucose Monitoring during 2 weeks

  12. Change in Body weight

    Time frame: Change from baseline to 12 weeks

    Body weight will be measured by a digital scale

  13. Change in Body composition (Fat mass and fat free mass)

    Time frame: Change from baseline to 12 weeks

    Body composition will be assessed by Dual-energy X-ray Absorptiometry (DXA)

  14. Change in Anthropometric measures

    Time frame: Change from baseline to 12 weeks

    Neck, hip and waist circumferences will be assessed by standard procedures

  15. Change in Blood pressure

    Time frame: Change from baseline to 12 weeks

    Systolic and Diastolic blood pressure will be assessed by standard procedures

  16. Change in energy intake

    Time frame: Change from baseline to 12 weeks

    Energy intake (kcal/day) will be assessed by 24h recalls

  17. Change in macronutrients intake

    Time frame: Change from baseline to 12 weeks

    Macronutrients intake (g/day and percentage of energy intake) will be assessed by 24h recalls

  18. Change in dietary habits

    Time frame: Change from baseline to 12 weeks

    Dietary habits will be assessed by food frequency questionnaires

  19. Change in Food craving

    Time frame: Change from baseline to 12 weeks

    Food craving will be assessed by the Food Craving Inventory (FCI)

  20. Change in Appetitive traits

    Time frame: Change from baseline to 12 weeks

    Appetitive traits will be assessed by the Adult Eating Behavior Questionnaire (AEBQ)

  21. Change in Subjective sleep quality

    Time frame: Change from baseline to 12 weeks

    Subjective sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI)

  22. Change in Objectively sleep quality

    Time frame: Change from baseline to 12 weeks

    Objectively sleep quality will be assessed by accelerometry

  23. Change in Chronotype

    Time frame: Change from baseline to 12 weeks

    Chronotype will be assessed by the Munich Chronotype Questionnaire (MCTQ)

  24. Change in Morning-Evening type

    Time frame: Change from baseline to 12 weeks

    Morning-Evening type will be assessed by the Morningness-Eveningness Questionnaire Self-Assessment Version.

  25. Change Subjective physical activity levels

    Time frame: Change from baseline to 12 weeks

    Subjective physical activity levels will be assessed by the International Physical Activity Questionnaire short form

  26. Change Objectively physical activity levels

    Time frame: Change from baseline to 12 weeks

    Objectively physical activity levels will be assessed by accelerometry

  27. Change in Depression aspects

    Time frame: Change from baseline to 12 weeks

    Depression aspects will be assessed by the Beck Depression Inventory Fast Screen (BDI-FS)

  28. Change in Stress aspects

    Time frame: Change from baseline to 12 weeks

    Stress aspects will be assessed by the Perceived Stress Scale (PSS)

  29. Change in Anxiety aspects

    Time frame: Change from baseline to 12 weeks

    Anxiety aspects will be assessed by the State-Trait Anxiety Inventory (STAI)

  30. Change in General health

    Time frame: Change from baseline to 12 weeks

    General health will be assessed by the EuroQol 5 dimensions 5 levels (EQ-5D-5L)

  31. Change in Quality of life

    Time frame: Change from baseline to 12 weeks

    Quality of life will be assessed by the Rand Short Form 36 (SF-36)

  32. Change in Gut microbiota composition

    Time frame: Change from baseline to 12 weeks

    DNA sequencing to determine gut microbiota composition (e.g., phylum and genera)

  33. Change in Gut microbiota diversity

    Time frame: Change from baseline to 12 weeks

    DNA sequencing to determine gut microbiota diversity (e.g., beta and alpha)

  34. Feasibility of recruitment

    Time frame: 12 weeks

    Feasibility of recruitment (i.e., percent of response rate).

  35. Feasibility of the intervention

    Time frame: 12 weeks

    Retention during the intervention (i.e., percent of attrition).

  36. Adherence to the intervention

    Time frame: Every day during the intervention, up to 90 days

    Adherence will be assessed by eating records

  37. Genetic variants in Clock genes

    Time frame: Baseline

    Genetic variantes in clock genes will be determined by Illumina sytem

Other outcomes

  1. Epigenetic changes in clock genes

    Time frame: Change from baseline to 12 weeks

    Changes in selected CpG in clock genes will be determined by Illumina system

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Collaborators

  • Universidad Pública de Navarra

Registry information

Official study title

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

Acronym: EXTREME

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 5, 2022
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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