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

Primary Purpose

Time Restricted Feeding, Obesity, Abdominal, Cardiometabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Early time-restricted eating
Late time-restricted eating
Self-selected time-restricted eating
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Time Restricted Feeding

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 30-65 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.
    • 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.

Sites / Locations

  • Universidad Pública de Navarra
  • University of Granada

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Early time-restricted eating

Late time-restricted eating

Self-selected time-restricted eating

Usual-care group

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Hepatic fat content
Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI)
Change in Pancreatic fat content
Pancreatic fat content will be assessed by Magnetic Resonance Imaging (MRI)
Change in Intramuscular fat content
Intramuscular fat content will be assessed by Magnetic Resonance Imaging (MRI)
Change in Hepatic elasticity
Hepatic elasticity will be assessed by US elastography
Change in Pancreatic elasticity
Pancreatic elasticity will be assessed by US elastography
Change in Fasting glucose metabolism
Fasting blood samples will be used to analyse different biomarkers of glucose metabolism
Change in Fasting lipid metabolism
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)
Change in Inflammatory profile
Fasting blood samples will be used to analyse inflammatory profile (e.g., C-reactive protein and interleukin 6)
Change in Hepatic profile
Fasting blood samples will be used to analyse hepatic profile (e.g., alkaline phosphatase, bilirubin, alanine transaminase and gamma-glutamyl transferase)
Change in Kidney profile
Fasting blood samples will be used to analyse kidney profile (e.g., creatinine and creatine kinase)
Change in Glycemia (Continuous Glucose Monitoring)
Glycemia will be assessed by Continuous Glucose Monitoring during 2 weeks
Change in Body weight
Body weight will be measured by a digital scale
Change in Body composition (Fat mass and fat free mass)
Body composition will be assessed by Dual-energy X-ray Absorptiometry (DXA)
Change in Anthropometric measures
Neck, hip and waist circumferences will be assessed by standard procedures
Change in Blood pressure
Systolic and Diastolic blood pressure will be assessed by standard procedures
Change in energy intake
Energy intake (kcal/day) will be assessed by 24h recalls
Change in macronutrients intake
Macronutrients intake (g/day and percentage of energy intake) will be assessed by 24h recalls
Change in dietary habits
Dietary habits will be assessed by food frequency questionnaires
Change in Food craving
Food craving will be assessed by the Food Craving Inventory (FCI)
Change in Appetitive traits
Appetitive traits will be assessed by the Adult Eating Behavior Questionnaire (AEBQ)
Change in Subjective sleep quality
Subjective sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI)
Change in Objectively sleep quality
Objectively sleep quality will be assessed by accelerometry
Change in Chronotype
Chronotype will be assessed by the Munich Chronotype Questionnaire (MCTQ)
Change in Morning-Evening type
Morning-Evening type will be assessed by the Morningness-Eveningness Questionnaire Self-Assessment Version.
Change Subjective physical activity levels
Subjective physical activity levels will be assessed by the International Physical Activity Questionnaire short form
Change Objectively physical activity levels
Objectively physical activity levels will be assessed by accelerometry
Change in Depression aspects
Depression aspects will be assessed by the Beck Depression Inventory Fast Screen (BDI-FS)
Change in Stress aspects
Stress aspects will be assessed by the Perceived Stress Scale (PSS)
Change in Anxiety aspects
Anxiety aspects will be assessed by the State-Trait Anxiety Inventory (STAI)
Change in General health
General health will be assessed by the EuroQol 5 dimensions 5 levels (EQ-5D-5L)
Change in Quality of life
Quality of life will be assessed by the Rand Short Form 36 (SF-36)
Change in Gut microbiota composition
DNA sequencing to determine gut microbiota composition (e.g., phylum and genera)
Change in Gut microbiota diversity
DNA sequencing to determine gut microbiota diversity (e.g., beta and alpha)
Feasibility of recruitment
Feasibility of recruitment (i.e., percent of response rate).
Feasibility of the intervention
Retention during the intervention (i.e., percent of attrition).
Adherence to the intervention
Adherence will be assessed by eating records
Genetic variants in Clock genes
Genetic variantes in clock genes will be determined by Illumina sytem

Full Information

First Posted
January 17, 2022
Last Updated
March 16, 2023
Sponsor
Universidad de Granada
Collaborators
Universidad Pública de Navarra
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1. Study Identification

Unique Protocol Identification Number
NCT05310721
Brief Title
Efficacy and Feasibility of Time-restricted Eating on Cardiometabolic Health in Adults With Overweight/Obesity
Acronym
EXTREME
Official Title
Efficacy and Feasibility of Time-restricted Eating on Cardiometabolic Health in Adults With Overweight/Obesity: The EXTREME Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
March 6, 2023 (Actual)
Study Completion Date
March 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
Collaborators
Universidad Pública de Navarra

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Time Restricted Feeding, Obesity, Abdominal, Cardiometabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
197 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early time-restricted eating
Arm Type
Experimental
Arm Description
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
Arm Title
Late time-restricted eating
Arm Type
Experimental
Arm Description
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
Arm Title
Self-selected time-restricted eating
Arm Type
Experimental
Arm Description
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
Arm Title
Usual-care group
Arm Type
No Intervention
Arm Description
Participants will receive standard recommendations on healthy lifestyle based on Mediterranean dietary pattern and physical activity recommendations for weight loss and health promotion
Intervention Type
Behavioral
Intervention Name(s)
Early time-restricted eating
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Late time-restricted eating
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Self-selected time-restricted eating
Intervention Description
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 Outcome Measure Information:
Title
Change in visceral adipose tissue
Description
Visceral adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)
Time Frame
Change from baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Change in Hepatic fat content
Description
Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI)
Time Frame
Change from baseline to 12 weeks
Title
Change in Pancreatic fat content
Description
Pancreatic fat content will be assessed by Magnetic Resonance Imaging (MRI)
Time Frame
Change from baseline to 12 weeks
Title
Change in Intramuscular fat content
Description
Intramuscular fat content will be assessed by Magnetic Resonance Imaging (MRI)
Time Frame
Change from baseline to 12 weeks
Title
Change in Hepatic elasticity
Description
Hepatic elasticity will be assessed by US elastography
Time Frame
Change from baseline to 12 weeks
Title
Change in Pancreatic elasticity
Description
Pancreatic elasticity will be assessed by US elastography
Time Frame
Change from baseline to 12 weeks
Title
Change in Fasting glucose metabolism
Description
Fasting blood samples will be used to analyse different biomarkers of glucose metabolism
Time Frame
Change from baseline to 12 weeks
Title
Change in Fasting lipid metabolism
Description
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)
Time Frame
Change from baseline to 12 weeks
Title
Change in Inflammatory profile
Description
Fasting blood samples will be used to analyse inflammatory profile (e.g., C-reactive protein and interleukin 6)
Time Frame
Change from baseline to 12 weeks
Title
Change in Hepatic profile
Description
Fasting blood samples will be used to analyse hepatic profile (e.g., alkaline phosphatase, bilirubin, alanine transaminase and gamma-glutamyl transferase)
Time Frame
Change from baseline to 12 weeks
Title
Change in Kidney profile
Description
Fasting blood samples will be used to analyse kidney profile (e.g., creatinine and creatine kinase)
Time Frame
Change from baseline to 12 weeks
Title
Change in Glycemia (Continuous Glucose Monitoring)
Description
Glycemia will be assessed by Continuous Glucose Monitoring during 2 weeks
Time Frame
Change from baseline to 12 weeks
Title
Change in Body weight
Description
Body weight will be measured by a digital scale
Time Frame
Change from baseline to 12 weeks
Title
Change in Body composition (Fat mass and fat free mass)
Description
Body composition will be assessed by Dual-energy X-ray Absorptiometry (DXA)
Time Frame
Change from baseline to 12 weeks
Title
Change in Anthropometric measures
Description
Neck, hip and waist circumferences will be assessed by standard procedures
Time Frame
Change from baseline to 12 weeks
Title
Change in Blood pressure
Description
Systolic and Diastolic blood pressure will be assessed by standard procedures
Time Frame
Change from baseline to 12 weeks
Title
Change in energy intake
Description
Energy intake (kcal/day) will be assessed by 24h recalls
Time Frame
Change from baseline to 12 weeks
Title
Change in macronutrients intake
Description
Macronutrients intake (g/day and percentage of energy intake) will be assessed by 24h recalls
Time Frame
Change from baseline to 12 weeks
Title
Change in dietary habits
Description
Dietary habits will be assessed by food frequency questionnaires
Time Frame
Change from baseline to 12 weeks
Title
Change in Food craving
Description
Food craving will be assessed by the Food Craving Inventory (FCI)
Time Frame
Change from baseline to 12 weeks
Title
Change in Appetitive traits
Description
Appetitive traits will be assessed by the Adult Eating Behavior Questionnaire (AEBQ)
Time Frame
Change from baseline to 12 weeks
Title
Change in Subjective sleep quality
Description
Subjective sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time Frame
Change from baseline to 12 weeks
Title
Change in Objectively sleep quality
Description
Objectively sleep quality will be assessed by accelerometry
Time Frame
Change from baseline to 12 weeks
Title
Change in Chronotype
Description
Chronotype will be assessed by the Munich Chronotype Questionnaire (MCTQ)
Time Frame
Change from baseline to 12 weeks
Title
Change in Morning-Evening type
Description
Morning-Evening type will be assessed by the Morningness-Eveningness Questionnaire Self-Assessment Version.
Time Frame
Change from baseline to 12 weeks
Title
Change Subjective physical activity levels
Description
Subjective physical activity levels will be assessed by the International Physical Activity Questionnaire short form
Time Frame
Change from baseline to 12 weeks
Title
Change Objectively physical activity levels
Description
Objectively physical activity levels will be assessed by accelerometry
Time Frame
Change from baseline to 12 weeks
Title
Change in Depression aspects
Description
Depression aspects will be assessed by the Beck Depression Inventory Fast Screen (BDI-FS)
Time Frame
Change from baseline to 12 weeks
Title
Change in Stress aspects
Description
Stress aspects will be assessed by the Perceived Stress Scale (PSS)
Time Frame
Change from baseline to 12 weeks
Title
Change in Anxiety aspects
Description
Anxiety aspects will be assessed by the State-Trait Anxiety Inventory (STAI)
Time Frame
Change from baseline to 12 weeks
Title
Change in General health
Description
General health will be assessed by the EuroQol 5 dimensions 5 levels (EQ-5D-5L)
Time Frame
Change from baseline to 12 weeks
Title
Change in Quality of life
Description
Quality of life will be assessed by the Rand Short Form 36 (SF-36)
Time Frame
Change from baseline to 12 weeks
Title
Change in Gut microbiota composition
Description
DNA sequencing to determine gut microbiota composition (e.g., phylum and genera)
Time Frame
Change from baseline to 12 weeks
Title
Change in Gut microbiota diversity
Description
DNA sequencing to determine gut microbiota diversity (e.g., beta and alpha)
Time Frame
Change from baseline to 12 weeks
Title
Feasibility of recruitment
Description
Feasibility of recruitment (i.e., percent of response rate).
Time Frame
12 weeks
Title
Feasibility of the intervention
Description
Retention during the intervention (i.e., percent of attrition).
Time Frame
12 weeks
Title
Adherence to the intervention
Description
Adherence will be assessed by eating records
Time Frame
Every day during the intervention, up to 90 days
Title
Genetic variants in Clock genes
Description
Genetic variantes in clock genes will be determined by Illumina sytem
Time Frame
Baseline
Other Pre-specified Outcome Measures:
Title
Epigenetic changes in clock genes
Description
Changes in selected CpG in clock genes will be determined by Illumina system
Time Frame
Change from baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonatan R. Ruiz, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Pública de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31006
Country
Spain
Facility Name
University of Granada
City
Granada
ZIP/Postal Code
18011
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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

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