TEMPUS: Time-Restricted Eating, Exercise and Cardiometabolic Health in Obesity
Study Details
Study Description
Brief Summary
In Spain, overweight and obesity prevalence is reaching 70% in men and 50% in women. Excess of triglycerides are usually stored in the subcutaneous adipose tissue (SAT), until a point where SAT is unable to expand further. Therefore, lipids are deposited in visceral and other peripheral organs and tissues that are not otherwise designed for adipose storage such as the liver, pancreas or the skeletal muscle, a process known as ectopic fat deposition. "Time-restricted eating" (TRE) is a recently emerged intermittent fasting approach which has the potential to maximize the beneficial metabolic effects extensively reported for energy intake restriction. Furthermore, exercise reduces hepatic steatosis and improves cardiometabolic health in humans. However, whether the effects of TRE combined with exercise on reducing hepatic steatosis are superior to TRE or exercise intervention alone remains unknown. The TEMPUS study will investigate the effects of a 12-week TRE combined with supervised exercise intervention, as compared with TRE or exercise alone, and usual-care control group, on hepatic fat (primary outcome) and cardiometabolic health (secondary outcomes) in adults with obesity; and to unveil the role of gut microbiota.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Time-restricted eating intervention Participants will be asked to reduce their daily eating time window to a maximum of 8 hours/day. They can choose when to begin their eating window but will be advised that the last meal should be completed before or at 20:00 hours. No calorie-containing food or beverage intake will be allowed outside the 8 hours eating window. |
Behavioral: Time-restricted eating intervention
Participants will be asked to reduce their daily eating time window to a maximum of 8 hours/day. They can choose when to begin their eating window but will be advised that the last meal should be completed before or at 20:00 hours. No calorie-containing food or beverage intake will be allowed outside the 8 hours eating window.
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| Experimental: Supervised exercise intervention The exercise intervention will include 2 days/week of supervised moderate-high intensity resistance training (rating perceived exertion >7, circuit-training, upper and lower body exercises involving major muscle groups) and high-intensity interval training (4 sets of 4-minute intervals at >85% peak heat rate with 4-minute of active recovery at 50-65% peak heat rate, uphill treadmill walking). Moreover, participants will receive an individualized moderate-intensity goal-setting aerobic (walking) program consisting of increasing 15% daily steps per week. |
Behavioral: Exercise intervention
The exercise intervention will include 2 days/week of supervised moderate-high intensity resistance training (rating perceived exertion >7, circuit-training, upper and lower body exercises involving major muscle groups) and high-intensity interval training (4 sets of 4-minute intervals at >85% peak heat rate with 4-minute of active recovery at 50-65% peak heat rate, uphill treadmill walking). This intervention has already been tested previously in our lab. Moreover, participants will receive an individualized moderate-intensity goal-setting aerobic (walking) program consisting of increasing 15% daily steps per week.
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| No Intervention: Usual-care control group Participants will receive standard recommendations on healthy lifestyle based on Mediterranean dietary pattern and physical activity recommendations for weight loss and health promotion. |
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| Experimental: Time-restricted eating plus Supervised exercise Participants will be asked to reduce their daily eating time window to a maximum of 8 hours/day. They can choose when to begin their eating window but will be advised that the last meal should be completed before or at 20:00 hours. No calorie-containing food or beverage intake will be allowed outside the 8 hours eating window. The exercise intervention will include 2 days/week of supervised moderate-high intensity resistance training (rating perceived exertion >7, circuit-training, upper and lower body exercises involving major muscle groups) and high-intensity interval training (4 sets of 4-minute intervals at >85% peak heat rate with 4-minute of active recovery at 50-65% peak heat rate, uphill treadmill walking). Moreover, participants will receive an individualized moderate-intensity goal- |
Behavioral: Time-restricted eating plus exercise intervention
Participants will be asked to reduce their daily eating time window to a maximum of 8 hours/day. They can choose when to begin their eating window but will be advised that the last meal should be completed before or at 20:00 hours. No calorie-containing food or beverage intake will be allowed outside the 8 hours eating window. The exercise intervention will include 2 days/week of supervised moderate-high intensity resistance training (rating perceived exertion >7, circuit-training, upper and lower body exercises involving major muscle groups) and high-intensity interval training (4 sets of 4-minute intervals at >85% peak heat rate with 4-minute of active recovery at 50-65% peak heat rate, uphill treadmill walking). This intervention has already been tested previously in our lab. Moreover, participants will receive an individualized moderate-intensity goal-setting aerobic (walking) program consisting of increasing 15% daily steps per week.
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Outcome Measures
Primary Outcome Measures
- Change in hepatic fat content [Change from baseline to 12 weeks]
Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI)
Secondary Outcome Measures
- Change in hepatic elasticity [Change from baseline to 12 weeks]
Hepatic elasticity will be assessed by US elastography
- Change in values of alkaline phosphatase [Change from baseline to 12 weeks]
Fasting blood samples will be used to asses alkaline phosphatase
- Change in values of alanine transaminase f [Change from baseline to 12 weeks]
Fasting blood samples will be used to asses alanine transaminase
- Change in values of gamma-glutamyl transferase [Change from baseline to 12 weeks]
Fasting blood samples will be used to assess gamma-glutamyl transferase
- Change in visceral adipose tissue [Change from baseline to 12 weeks]
Visceral adipose tissue 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 values of fasting glucose [Change from baseline to 12 weeks]
Fasting blood samples will be used to assess glucose
- Change in values of fasting insulin [Change from baseline to 12 weeks]
Fasting blood samples will be used to assess insulin
- Change in HOMA-IR index. [Change from baseline to 12 weeks]
Fasting blood samples will be used to assess glucose and insuline and HOMA index will be computed
- Change in values of HbA1c. [Change from baseline to 12 weeks]
Fasting blood samples will be used to assess HbA1c
- Change in values of fasting triglycerides [Change from baseline to 12 weeks]
Fasting blood samples will be used to assess levels of triglycerides
- Change in values of fasting high-density lipoprotein cholesterol [Change from baseline to 12 weeks]
Fasting blood samples will be used to assess levels of high-density lipoprotein cholesterol
- Change in values of fasting low-density lipoprotein cholesterol [Change from baseline to 12 weeks]
Fasting blood samples will be used to assess levels of low-density lipoprotein cholesterol
- Change in values of fasting total cholesterol [Change from baseline to 12 weeks]
Fasting blood samples will be used to assess levels of total cholesterol
- Change in values of C-reactive protein [Change from baseline to 12 weeks]
Fasting blood samples will be used to assess levels of C-reactive protein
- Change in values of interleukin 6 [Change from baseline to 12 weeks]
Fasting blood samples will be used to assess levels of interleukin 6
- Change in values of creatinine [Change from baseline to 12 weeks]
Fasting blood samples will be used to assess levels of creatinine
- Change in values of creatine kinase [Change from baseline to 12 weeks]
Fasting blood samples will be used to assess levels of creatine kinase
- Change in levels of mean glucose (Continuous Glucose Monitoring) [Change from baseline to the last 2 weeks of intervention]
Men glucose over 14 days 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 Fat mass [Change from baseline to 12 weeks]
Fat mass will be assessed by Dual-energy X-ray Absorptiometry (DXA)
- Change in fat free mass [Change from baseline to 12 weeks]
Fat free mass will be assessed by Dual-energy X-ray Absorptiometry (DXA)
- Change in waist circumference [Change from baseline to 12 weeks]
Waist circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry
- Change in hip circumference [Change from baseline to 12 weeks]
Hip circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry
- Change in neck circumference [Change from baseline to 12 weeks]
Neck circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry
- Change in systolic blood pressure [Change from baseline to 12 weeks]
Systolic blood pressure will be assessed by blood pressure monitor
- Change in diastolic blood pressure [Change from baseline to 12 weeks]
Diastolic blood pressure will be assessed by blood pressure monitor
- Change in energy intake [Change from baseline to 12 weeks]
Energy intake (kcal/day) will be assessed by 24h recalls
- Change in carbohydrates intake [Change from baseline to 12 weeks]
Macronutrients intake (g/day and percentage of energy intake) will be assessed by 24h recalls
- Change in fat intake [Change from baseline to 12 weeks]
Fat intake (g/day and percentage of energy intake) will be assessed by 24h recalls
- Change in protein intake [Change from baseline to 12 weeks]
Protein intake (g/day and percentage of energy intake) will be assessed by 24h recalls
- Change in dietary habits [Change from baseline to 12 weeks]
Dietary habits will be assessed by food frequency questionnaire (FFQ). Minimum value is 1 (never) and maximum value is 9 (more than 6 times per day). Higher values mean a more frequency of a certain food consumption.
- Change in Appetite traits [Change from baseline to 12 weeks]
Appetite traits will be assessed by the Adult Eating Behavior Questionnaire (AEBQ). Minimum value is 1 (completely disagree) and maximum value is 5 (completely agree). Higher values mean a worse outcome.
- Change in Subjective sleep quality [Change from baseline to 12 weeks]
Subjective sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI). Minimum value is 0 (never) and maximum value is 3 (3 or more times per week). Higher values mean a worse outcome.
- 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. Define if a person is more morningness or eveningness based on daily times preferences.
- Change Objectively moderate to vigorous 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). Values ranged from 0 to 63. Higher values mean worse outcome.
- Change in Stress aspects [Change from baseline to 12 weeks]
Stress aspects will be assessed by the Perceived Stress Scale (PSS). Values ranged from 0 to 40. Higher values mean worse outcome.
- Change in Anxiety aspects [Change from baseline to 12 weeks]
Anxiety aspects will be assessed by the State-Trait Anxiety Inventory (STAI). Values ranged from 0 to 60. Higher values mean worse outcome.
- 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). Values ranged from 0 to 100. Higher values mean better outcome.
- 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). Values ranged from 0 to 100. Higher values mean better outcome.
- 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)
- Change in Cardiorespiratory Fitness [Change from baseline to 12 weeks]
Cardiorespiratory fitness measured by maximum treadmill test to adjust the exercise intensity. Higher values mean better outcome.
- Change in Lower muscular strength [Change from baseline to 12 weeks]
Lower body muscular strength measured by chair stand test. Higher values mean better outcome.
- Change in Upper muscular strength [Change from baseline to 12 weeks]
Upper body muscular strength measured by hand grip strength test. Higher values mean better outcome.
- Change in walking speed. [Change from baseline to 12 weeks]
Walking speed measured by gait speed test. Higher values mean worse outcome.
- Adherence to the intervention [Change from baseline to 12 weeks]
Adherence will be assessed by eating records and by number of completed exercise sessions.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged 25-65 years.
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Body mass index ≥28.0 and <40.0 kg/m2.
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Weight stability (within 5% of screening weight) for >3 months prior to study entry.
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Habitual eating window ≥11 hours.
Exclusion Criteria:
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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.
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Type 1 or Type 2 diabetes.
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Major psychiatric disorders, eating disorders, sleep disorders, or alcohol abuse.
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Regular use of medication or compounds that may affect study outcomes (e.g., antidiabetic, steroids, beta-blockers, antibiotics, prebiotics, probiotics and symbiotics).
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Participating in a weight loss, a weight-management program or a supervised exercise program (more than 30 minutes three times per week, or 45 minutes twice a week, moderate/vigorous intensity).
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Pregnancy and lactation or planned pregnancy (within the study period).
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Caregiver for a dependent requiring frequent nocturnal care/sleep interruptions. Shift workers with variable hours (e.g., nocturnal).
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Frequent travel over time zones during the study period.
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Fear of needles and claustrophobia to magnetic resonance imaging (MRI).
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Being unable to understand and to accept the instructions or the study objectives and protocol.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Granada - Instituto Mixto Universitario Deporte y Salud | Granada | Spain | 18011 | |
| 2 | University of Granada | Granada | Spain | 18011 |
Sponsors and Collaborators
- Universidad de Granada
Investigators
- Principal Investigator: Jonatan R. Ruiz, PhD, Universidad de Granada
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TEMPUS