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Clinical Trials/NCT03236285
NCT03236285WithdrawnNot Applicable

Microvascular and Metabolic Effects of High-intensity Interval Training (HIIT) and Intermittent Fasting (FAST) in Overweight or Obese, Sedentary Women With Cardiometabolic Risk Factors: HIIT-FAST, a Randomized Clinical Trial

National Institute of Cardiology, Laranjeiras, Brazil2 sites in 1 countryStarted: February 20, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Sponsor
Locations
2
Primary Endpoint
Capillary density

Study Overview

Brief Summary

The study investigates the effects of high intensity interval training (HIIT) versus continuous training (CT), combined or not with fasting, on capillary density, microvascular function, cardiometabolic risk markers, functional capacity, and quality of life, in overweight or obese sedentary women with cardiometabolic risk factors. The use of HIIT could promote greater improvements in these parameters than CT. Furthermore, the positive effects of exercise may increase when it is performed in the fasting state, compared to exercise performed in the fed state.

Detailed Description

Physical inactivity and increased caloric intake play important roles in the pathophysiology of obesity. Increases of physical activity and modifications of eating behaviors are first-line interventions which, however, are not easily implemented, and lack of time to exercise and difficulties in coping with different diets are common reasons for failure. High-intensity interval training (HIIT) is a "faster" alternative to moderate-intensity continuous training (CT). Conversely, intermittent fasting is also an alternative to more complex diets, as it restricts caloric intake to a specified period of time without major diet composition changes. The combination of HIIT and fasting may therefore provide incremental benefits.

Sedentary women aged ≥ 30 years and ≤50 years, with body mass index ≥25 kg/m2 and cardiometabolic risk factors, will be randomized to HIIT performed in the fasting state, HIIT performed in the fed state, CT in the fasting state or CT in the fed state. Cardiometabolic parameters, anthropometric indices, cardiorespiratory fitness, quality of life and microvascular function (cutaneous capillary density and microvascular reactivity evaluated by laser speckle contrast imaging) will be evaluated before the initiation of the interventions and 4 weeks thereafter.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
30 Years to 50 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Female gender
  • Age≥ 30 years and ≤50 years
  • Premenopausal status
  • Body mass index >25 kg/m2
  • At least one of the following:
  • waist circumference ≥80 cm (women); triglycerides ≥150 mg/dl or treatment for this lipid abnormality; High density-lipoprotein cholesterol <50 mg/dl (women), or treatment for this abnormality; fasting plasma glucose ≥100 mg/dl

Exclusion Criteria

  • Any cardiovascular disease, including systemic hypertension
  • Diabetes mellitus
  • Chronic pulmonary disease
  • Any systemic disease or condition that might reduce the adherence or tolerance to exercise or fasting
  • Orthopedic or neurologic conditions that might impair exercise training
  • Pregnancy or breastfeeding
  • Abnormalities elicited at exercise treadmill testing that preclude the initiation of exercise training
  • Current engagement in any exercise training protocol

Arms & Interventions

HIIT only

Experimental

Volunteers will be submitted to high-intensity interval training (HIIT) performed in fed state

Intervention: High-intensity interval exercise training in the fed state (Behavioral)

CT+FAST

Experimental

Volunteers will be submitted to continous training (CT) performed in the fasting state

Intervention: Continous exercise training in the fasting state (Behavioral)

CT only

Experimental

Volunteers will be submitted to continous training (CT) performed in fed state.

Intervention: Continous exercise training in the fed state (Behavioral)

HIIT+FAST

Experimental

Volunteers will be submitted to high-intensity interval training (HIIT) performed in the fasting state.

Intervention: High-intensity interval exercise training in the fasting state (Behavioral)

Outcomes

Primary Outcomes

Capillary density

Time Frame: 6 months

Number of spontaneously perfused skin capillaries per mm2

Secondary Outcomes

  • Microvascular reactivity assessed by laser speckle contrast imaging(6 months)

Investigators

Sponsor
National Institute of Cardiology, Laranjeiras, Brazil
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Eduardo Tibirica, MD, PhD

MD, PhD

National Institute of Cardiology, Laranjeiras, Brazil

Study Sites (2)

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