Microvascular and Metabolic Effects of High-intensity Interval Exercise Training (HIIT-FAST)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Obesity; Overweight; Physical Activity
• Intervention / Treatment: Behavioral: High-intensity interval exercise training in the fed state; Behavioral: Continous exercise training in the fasting state; Behavioral: Continous exercise training in the fed state; Behavioral: High-intensity interval exercise training in the fasting 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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 22240-006
    • National Institute of Cardiology, Ministry of Health, Brazil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIIT only; Volunteers will be submitted to high-intensity interval training (HIIT) performed in fed state	Behavioral: High-intensity interval exercise training in the fed state; High-intensity interval exercise training in the fed state
Experimental: CT+FAST; Volunteers will be submitted to continous training (CT) performed in the fasting state	Behavioral: Continous exercise training in the fasting state; Continous exercise training in the fasting state
Experimental: CT only; Volunteers will be submitted to continous training (CT) performed in fed state.	Behavioral: Continous exercise training in the fed state; Continous exercise training in the fed state
Experimental: HIIT+FAST; Volunteers will be submitted to high-intensity interval training (HIIT) performed in the fasting state.	Behavioral: High-intensity interval exercise training in the fasting state; High-intensity interval exercise training in the fasting state

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Capillary density	Number of spontaneously perfused skin capillaries per mm2	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microvascular reactivity assessed by laser speckle contrast imaging	Skin microvascular flow in arbitrary perfusion units	6 months

Collaborators and Investigators

• Sponsor: National Institute of Cardiology, Laranjeiras, Brazil
• Investigators: Principal Investigator: EDUARDO V TIBIRICA, MD, PhD, National Innstitute of Cardiology

Publications and helpful links

General Publications

• De Lorenzo A, Van Bavel D, de Moraes R, Tibirica EV. High-intensity interval training or continuous training, combined or not with fasting, in obese or overweight women with cardiometabolic risk factors: study protocol for a randomised clinical trial. BMJ Open. 2018 Apr 28;8(4):e019304. doi: 10.1136/bmjopen-2017-019304.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2018
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: July 27, 2017
• First Submitted That Met QC Criteria: July 31, 2017
• First Posted (Actual): August 1, 2017

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 11, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Obesity; Endothelial function; Microcirculation; Capillary density; Laser speckle imaging
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: CAAE:69240017.1.0000.5272

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No