Cardiometabolic Syndrome, Exercise, Metabolic Syndrome, Obesity, Time Restricted Eating, Weight Loss
Conditions
Keywords
Metabolic syndrome, HIIT, Exercise training, Time restricted eating
Brief summary
Studies in mice provide compelling evidence that feeding/fasting cycles can be altered to produce beneficial effects on weight loss and cardiometabolic health markers in the absence of caloric restriction. Limited research in subjects with metabolic syndrome (MetS) suggests that this feeding paradigm may also apply to human health when combined with an exercise training program, but more research is needed to confirm this hypothesis. This project will determine the independent and combined effects of high-intensity interval training and time-restricted eating on cardiometabolic factors among overweight or obese patients with MetS. The intervention period will be sixteen weeks. Before and after the intervention, MetS components (i.e., MetS Z score), body composition, and physical fitness will be measured and compared between groups who are doing either high-intensity interval training, time-restricted eating, both high-intensity interval training and time-restricted eating, or who are in a control group. Physical activity, diet, sleep quality, and intervention adherence will also be measured.
Interventions
BEHAVIORALHigh-Intensity Interval Training
Three weekly, supervised exercise sessions with high intensity. Each session will last for 45 minutes. The intervention period will be sixteen weeks.
BEHAVIORALExperimental: Time-Restricted Eating
Restricted daily window of caloric intake to a maximum 10 hours. The intervention period will be sixteen weeks.
Sponsors
University of Castilla-La Mancha
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Metabolic syndrome patients diagnosed according to The International diabetes federation consensus of 2009 (Alberti, et al., Circulation): * Waist circumference ≥ 92 cm (Men) or ≥ 80 cm (Women). * Triglycerides ≥ 150 mg/dL (or on drug treatment for elevated triglycerides). * Reduced HDL-C \< 40 mg/dL (Men), \< 50 mg/dL (Women) (or on drug treatment for reduced HDL-C). * Elevated blood pressure, systolic blood pressure ≥ 130 mmHg and/or diastolic blood pressure ≥ 85 mmHg (or treatment with an antihypertensive drug with a history of hypertension). * Elevated fasting glucose ≥ 100 mg/dL (or drug treatment of elevated blood glucose). * Age ≥18 to ≤65 years * Previously inactive (\<150 min·wk-1 of the moderate-intensity activity assessed by 7-d IPAQ
Exclusion criteria
* Pregnancy, and lactation within 24 weeks of study commencement * Untreated cardiovascular or renal disease * Type 1 diabetes * Any condition associated with exercise intolerance. * Habitual eating window \< 12 hours * Performing high-intensity training more than once a week * Body mass variations \> 4 kg three months prior to study commencement * Shift work that includes night shifts
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic Syndrome Z score | Baseline and after 16 weeks of intervention | MetS z score will be used to assess the continuous rather than dichotomous (have/not haveMetS) evolution of each MetS component into a compound score. We will calculate the Z score as the difference between the subjects and the threshold value divided by the group standard deviations for each MetS criterion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood lipids profile | Baseline and after 16 weeks of intervention | Serum concentrations (in mg per dL) of triglycerides, total colesterol, high density lipoprotein after 8-hour fasting |
| Glycemia | Baseline and after 16 weeks of intervention | Serum concentrations of glycemia (in mg per dL) after 8-hour fasting |
| Blood pressure | Baseline and after 16 weeks of intervention | Systolic and diastolic values of blood pressure measures obtained from the brachial artery after 15 min of supine rest. |
| Central obesity | Baseline and after 16 weeks of intervention | Measure waist circumference (cm) in a horizontal plane, midway between the ribs' inferior margin and the iliac crest's superior border. |
| Body composition | Baseline and after 16 weeks of intervention | Measurement of the mass of man body compartments (i.e., VAT \[visceral adipose tissue\] fat mass, fat-free mass, and bone mass) by dual-energy x-ray absorptiometry. |
| Insulin | Baseline and after 16 weeks of intervention | Serum concentrations of insulin after 8-hour fasting |
| Insulin sensitivity | Baseline and after 16 weeks of intervention | Insulin sensitivity estimated by homeostatic model assessment for insulin resistance (fasting serum insulin concentration (μU/mL) x fasting plasma glucose levels (mmol/L)/22.5) |
| Cardiorespiratory fitness | Baseline and after 16 weeks of intervention | Maximum oxygen uptake from a graded exercise test plus a verification test |
Countries
Spain
Outcome results
None listed