NCT04477590

Interactions of Medicine and Exercise With Meal Timing

Optimizing Exercise Training Effects on Metabolic Syndrome Factors by Altering the Timing of Medication and Meal Ingestion

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: University of Castilla-La Mancha · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DRUG	EXERCISE TRAINING WITH OR WITHOUT MEDICATION	A group will train 30 min after taking their habitual dose of medicine (MEDICATED train) while another group will train after taking a placebo (NON-MEDICATED train) and will receive their medication after training.

Timeline

• Start date: 2022-06-07
• Primary completion: 2024-05-30
• Completion: 2024-12-30
• First posted: 2020-07-20
• Last updated: 2023-08-25

Locations

1 site across 1 country: Spain