Interactions of Medicine and Exercise With Meal Timing (MMET)

University of Castilla-La Mancha

Status: Enrolling

Conditions: Angiotensin-Converting-Enzyme Inhibitor; Metformin; Exercise Training; Statins; Metabolic Syndrome, Protection Against; Angiotensin Hypertension; Fasting, Intermittent

Treatments: Drug: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Study type: Interventional

Funder types: Other

Identifiers

NCT04477590

DEP2017-83244-R

Details and patient eligibility

About

To analyze the effects of altering the time of ingestion of participants' habitual medication (i.e., metformin, statins, ARAII/IACE) and meals around the time of exercise training (exercise fasted or fed) on the improvement of metabolic syndrome factors (hypertension, insulin sensitivity, dyslipidemia, and obesity). There will be a preliminary study of the effects of training "time-of-day" on the primary study outcomes.

Full description

Objective: The purpose is to study in a group of adults with metabolic syndrome and obesity, the effects of altering timing between exercise training, meals, and their habitual medication on the improvement in the factors that compose the metabolic syndrome (i.e., hypertension, insulin resistance, central obesity, and dyslipidemia). The main objective is to find the most productive combination between exercise training and the timing of their habitual pharmacological treatment, and meal ingestion for lowering those factors.

Methods and design: Cross-over randomized double-blinded, pretest-posttest control group experimental design. The project will be developed in a single center with the collaboration of the regional public health system (SECAM). There will be a preliminary study of the effects of training "time-of-day" on three parallel groups of individuals.

Subjects: Will be referred by their primary care physicians to our study unit or recruited by advertisements in local media.

Up to 180 subjects, all of them with metabolic syndrome will be recruited (>25% women).

Measurements:

Specifically, we will study if the cardiovascular and metabolic adaptations to aerobic training that result in amelioration of metabolic syndrome factors are potentiated by correct timming of training, meals, and medicine around exercise training time.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Metabolic syndrome patients diagnosed according to The International diabetes federation consensus of 2009 (Alberti, et al., Circulation).

Exclusion criteria

• Cardiovascular disease or musculo-skeletal that prevents them from being able to perform intense exercise.

  • Respiratory failure
  • Liver o renal disease
  • Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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160 participants in 3 patient groups

NO EXERCISE TRAINING

No Intervention group

Description:

25-32 individuals with metabolic syndrome that will remain sedentary during the 4 months of treatment taking their habitual medication (i.e., blood pressure, glucose, cholesterol, and triglycerides lowering drugs) and meals at the habitual time (CONTROL GROUP).

EXERCISE TRAINING FED

Experimental group

Description:

2 groups of 25-32 individuals with metabolic syndrome that will exercise-train during 16 weeks after ingesting a liquid test meal (500 calls, 50% fat) 30 min before exercise (EXERCISE TRAINING FED).

Treatment:

Drug: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

EXERCISE TRAINING FASTED

Experimental group

Description:

2 groups of 25-32 individuals with metabolic syndrome that will exercise-train during 16 weeks after ingestion of a placebo meal (0 kcals) 30 min before exercise (EXERCISE TRAINING FAST).

Treatment:

Drug: EXERCISE TRAINING WITH OR WITHOUT MEDICATION