Microvascular and Metabolic Effects of High-intensity Interval Exercise Training

Obesity Clinical Trial

— HIIT-FAST  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03236285
• Other study ID #: CAAE:69240017.1.0000.5272
• Status: Withdrawn
• Phase: N/A
• Start date: February 20, 2018
• Est. completion date: October 2021

Study information

• Verified date: March 2019
• Source: National Institute of Cardiology, Laranjeiras, Brazil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Physical Activity

Intervention

Behavioral:
• High-intensity interval exercise training in the fed state
High-intensity interval exercise training in the fed state
• Continous exercise training in the fed state
Continous exercise training in the fed state
• High-intensity interval exercise training in the fasting state
High-intensity interval exercise training in the fasting state
• Continous exercise training in the fasting state
Continous exercise training in the fasting state

Locations

Country	Name	City	State
Brazil	National Institute of Cardiology, Ministry of Health, Brazil	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Cardiology, Laranjeiras, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Capillary density	Number of spontaneously perfused skin capillaries per mm2	6 months
Secondary	Microvascular reactivity assessed by laser speckle contrast imaging	Skin microvascular flow in arbitrary perfusion units	6 months