Cardiometabolic Syndrome, Obesity, Abdominal, Time Restricted Feeding
Conditions
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.
Interventions
BEHAVIORALEarly 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
BEHAVIORALLate 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
BEHAVIORALSelf-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
Sponsors
Universidad Pública de Navarra
Universidad de Granada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in visceral adipose tissue | Change from baseline to 12 weeks | Visceral adipose tissue will be assessed by Magnetic Resonance Imaging (MRI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hepatic fat content | Change from baseline to 12 weeks | Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI) |
| Change in Pancreatic fat content | Change from baseline to 12 weeks | Pancreatic fat content will be assessed by Magnetic Resonance Imaging (MRI) |
| Change in Intramuscular fat content | Change from baseline to 12 weeks | Intramuscular fat content will be assessed by Magnetic Resonance Imaging (MRI) |
| Change in Hepatic elasticity | Change from baseline to 12 weeks | Hepatic elasticity will be assessed by US elastography |
| Change in Pancreatic elasticity | Change from baseline to 12 weeks | Pancreatic elasticity will be assessed by US elastography |
| Change in Fasting glucose metabolism | Change from baseline to 12 weeks | Fasting blood samples will be used to analyse different biomarkers of glucose metabolism |
| Change in Fasting lipid metabolism | 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) |
| Change in Inflammatory profile | Change from baseline to 12 weeks | Fasting blood samples will be used to analyse inflammatory profile (e.g., C-reactive protein and interleukin 6) |
| Change in Hepatic profile | 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) |
| Change in Kidney profile | Change from baseline to 12 weeks | Fasting blood samples will be used to analyse kidney profile (e.g., creatinine and creatine kinase) |
| Genetic variants in Clock genes | Baseline | Genetic variantes in clock genes will be determined by Illumina sytem |
| Change in Glycemia (Continuous Glucose Monitoring) | Change from baseline to 12 weeks | Glycemia will be assessed by Continuous Glucose Monitoring during 2 weeks |
| Change in Body weight | Change from baseline to 12 weeks | Body weight will be measured by a digital scale |
| Change in Body composition (Fat mass and fat free mass) | Change from baseline to 12 weeks | Body composition will be assessed by Dual-energy X-ray Absorptiometry (DXA) |
| Change in Blood pressure | Change from baseline to 12 weeks | Systolic and Diastolic blood pressure will be assessed by standard procedures |
| Change in Anthropometric measures | Change from baseline to 12 weeks | Neck, hip and waist circumferences will be assessed by standard procedures |
| Change in energy intake | Change from baseline to 12 weeks | Energy intake (kcal/day) will be assessed by 24h recalls |
| Change in macronutrients intake | Change from baseline to 12 weeks | Macronutrients intake (g/day and percentage of energy intake) will be assessed by 24h recalls |
| Feasibility of recruitment | 12 weeks | Feasibility of recruitment (i.e., percent of response rate). |
| Feasibility of the intervention | 12 weeks | Retention during the intervention (i.e., percent of attrition). |
| Change in dietary habits | Change from baseline to 12 weeks | Dietary habits will be assessed by food frequency questionnaires |
| Change in Food craving | Change from baseline to 12 weeks | Food craving will be assessed by the Food Craving Inventory (FCI) |
| Change in Appetitive traits | Change from baseline to 12 weeks | Appetitive traits will be assessed by the Adult Eating Behavior Questionnaire (AEBQ) |
| Adherence to the intervention | Every day during the intervention, up to 90 days | Adherence will be assessed by eating records |
| Change in Subjective sleep quality | Change from baseline to 12 weeks | Subjective sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI) |
| Change in Objectively sleep quality | Change from baseline to 12 weeks | Objectively sleep quality will be assessed by accelerometry |
| Change in Chronotype | Change from baseline to 12 weeks | Chronotype will be assessed by the Munich Chronotype Questionnaire (MCTQ) |
| Change in Morning-Evening type | Change from baseline to 12 weeks | Morning-Evening type will be assessed by the Morningness-Eveningness Questionnaire Self-Assessment Version. |
| Change Subjective physical activity levels | Change from baseline to 12 weeks | Subjective physical activity levels will be assessed by the International Physical Activity Questionnaire short form |
| Change Objectively physical activity levels | Change from baseline to 12 weeks | Objectively physical activity levels will be assessed by accelerometry |
| Change in Depression aspects | Change from baseline to 12 weeks | Depression aspects will be assessed by the Beck Depression Inventory Fast Screen (BDI-FS) |
| Change in Stress aspects | Change from baseline to 12 weeks | Stress aspects will be assessed by the Perceived Stress Scale (PSS) |
| Change in Anxiety aspects | Change from baseline to 12 weeks | Anxiety aspects will be assessed by the State-Trait Anxiety Inventory (STAI) |
| Change in General health | Change from baseline to 12 weeks | General health will be assessed by the EuroQol 5 dimensions 5 levels (EQ-5D-5L) |
| Change in Quality of life | Change from baseline to 12 weeks | Quality of life will be assessed by the Rand Short Form 36 (SF-36) |
| Change in Gut microbiota composition | Change from baseline to 12 weeks | DNA sequencing to determine gut microbiota composition (e.g., phylum and genera) |
| Change in Gut microbiota diversity | Change from baseline to 12 weeks | DNA sequencing to determine gut microbiota diversity (e.g., beta and alpha) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Epigenetic changes in clock genes | Change from baseline to 12 weeks | Changes in selected CpG in clock genes will be determined by Illumina system |
Countries
Spain
Outcome results
None listed