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

Obesity, Abdominal Clinical Trial

— EXTREME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05310721
• Other study ID #: EXTREME
• Status: Completed
• Phase: N/A
• Start date: April 11, 2022
• Est. completion date: March 6, 2023

Study information

• Verified date: November 2023
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: March 6, 2023
• Est. primary completion date: March 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiometabolic Syndrome
• Metabolic Syndrome
• Obesity
• Obesity, Abdominal
• Overweight
• Time Restricted Feeding

Intervention

Behavioral:
• Early time-restricted eating
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
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
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

Locations

Country	Name	City	State
Spain	University of Granada	Granada
Spain	Universidad Pública de Navarra	Pamplona	Navarra

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Granada	Universidad Pública de Navarra

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Epigenetic changes in clock genes	Changes in selected CpG in clock genes will be determined by Illumina system	Change from baseline to 12 weeks
Primary	Change in visceral adipose tissue	Visceral adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)	Change from baseline to 12 weeks
Secondary	Change in Hepatic fat content	Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI)	Change from baseline to 12 weeks
Secondary	Change in Pancreatic fat content	Pancreatic fat content will be assessed by Magnetic Resonance Imaging (MRI)	Change from baseline to 12 weeks
Secondary	Change in Intramuscular fat content	Intramuscular fat content will be assessed by Magnetic Resonance Imaging (MRI)	Change from baseline to 12 weeks
Secondary	Change in Hepatic elasticity	Hepatic elasticity will be assessed by US elastography	Change from baseline to 12 weeks
Secondary	Change in Pancreatic elasticity	Pancreatic elasticity will be assessed by US elastography	Change from baseline to 12 weeks
Secondary	Change in Fasting glucose metabolism	Fasting blood samples will be used to analyse different biomarkers of glucose metabolism	Change from baseline to 12 weeks
Secondary	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 from baseline to 12 weeks
Secondary	Change in Inflammatory profile	Fasting blood samples will be used to analyse inflammatory profile (e.g., C-reactive protein and interleukin 6)	Change from baseline to 12 weeks
Secondary	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 from baseline to 12 weeks
Secondary	Change in Kidney profile	Fasting blood samples will be used to analyse kidney profile (e.g., creatinine and creatine kinase)	Change from baseline to 12 weeks
Secondary	Change in Glycemia (Continuous Glucose Monitoring)	Glycemia will be assessed by Continuous Glucose Monitoring during 2 weeks	Change from baseline to 12 weeks
Secondary	Change in Body weight	Body weight will be measured by a digital scale	Change from baseline to 12 weeks
Secondary	Change in Body composition (Fat mass and fat free mass)	Body composition will be assessed by Dual-energy X-ray Absorptiometry (DXA)	Change from baseline to 12 weeks
Secondary	Change in Anthropometric measures	Neck, hip and waist circumferences will be assessed by standard procedures	Change from baseline to 12 weeks
Secondary	Change in Blood pressure	Systolic and Diastolic blood pressure will be assessed by standard procedures	Change from baseline to 12 weeks
Secondary	Change in energy intake	Energy intake (kcal/day) will be assessed by 24h recalls	Change from baseline to 12 weeks
Secondary	Change in macronutrients intake	Macronutrients intake (g/day and percentage of energy intake) will be assessed by 24h recalls	Change from baseline to 12 weeks
Secondary	Change in dietary habits	Dietary habits will be assessed by food frequency questionnaires	Change from baseline to 12 weeks
Secondary	Change in Food craving	Food craving will be assessed by the Food Craving Inventory (FCI)	Change from baseline to 12 weeks
Secondary	Change in Appetitive traits	Appetitive traits will be assessed by the Adult Eating Behavior Questionnaire (AEBQ)	Change from baseline to 12 weeks
Secondary	Change in Subjective sleep quality	Subjective sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI)	Change from baseline to 12 weeks
Secondary	Change in Objectively sleep quality	Objectively sleep quality will be assessed by accelerometry	Change from baseline to 12 weeks
Secondary	Change in Chronotype	Chronotype will be assessed by the Munich Chronotype Questionnaire (MCTQ)	Change from baseline to 12 weeks
Secondary	Change in Morning-Evening type	Morning-Evening type will be assessed by the Morningness-Eveningness Questionnaire Self-Assessment Version.	Change from baseline to 12 weeks
Secondary	Change Subjective physical activity levels	Subjective physical activity levels will be assessed by the International Physical Activity Questionnaire short form	Change from baseline to 12 weeks
Secondary	Change Objectively physical activity levels	Objectively physical activity levels will be assessed by accelerometry	Change from baseline to 12 weeks
Secondary	Change in Depression aspects	Depression aspects will be assessed by the Beck Depression Inventory Fast Screen (BDI-FS)	Change from baseline to 12 weeks
Secondary	Change in Stress aspects	Stress aspects will be assessed by the Perceived Stress Scale (PSS)	Change from baseline to 12 weeks
Secondary	Change in Anxiety aspects	Anxiety aspects will be assessed by the State-Trait Anxiety Inventory (STAI)	Change from baseline to 12 weeks
Secondary	Change in General health	General health will be assessed by the EuroQol 5 dimensions 5 levels (EQ-5D-5L)	Change from baseline to 12 weeks
Secondary	Change in Quality of life	Quality of life will be assessed by the Rand Short Form 36 (SF-36)	Change from baseline to 12 weeks
Secondary	Change in Gut microbiota composition	DNA sequencing to determine gut microbiota composition (e.g., phylum and genera)	Change from baseline to 12 weeks
Secondary	Change in Gut microbiota diversity	DNA sequencing to determine gut microbiota diversity (e.g., beta and alpha)	Change from baseline to 12 weeks
Secondary	Feasibility of recruitment	Feasibility of recruitment (i.e., percent of response rate).	12 weeks
Secondary	Feasibility of the intervention	Retention during the intervention (i.e., percent of attrition).	12 weeks
Secondary	Adherence to the intervention	Adherence will be assessed by eating records	Every day during the intervention, up to 90 days
Secondary	Genetic variants in Clock genes	Genetic variantes in clock genes will be determined by Illumina sytem	Baseline