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HIIT Versus MICT on Abdominal Fat Mass and Lipid Oxidation in Postmenopausal Women (MATISSE) (MATISSE)

Primary Purpose

Overweight, Post Menopausal Women

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Training programs
Sponsored by
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring interval training, abdominal fat mass, postmenopausal women, lipids oxidation

Eligibility Criteria

55 Years - 82 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Postmenopausal women (55- 82 years)
  • BMI ≥ 25 and < 40
  • Able to follow an exercise protocol
  • Eating behavior and physical activity stable since at least 3 month

Exclusion Criteria:

  • Subject not able to perform exercise after medical examination
  • Subject not able to perform bicycle exercise (pains)
  • Chronic infection
  • Use of β-blocker
  • Medical treatment that could interfere with the different outcome measures
  • Hormonal Replacement Therapy (HRT)
  • Regular consumption of alcohol
  • Refusal to sign the consent form

Sites / Locations

  • CREPS Vichy Auvergne

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

High Intensity Interval Training program (HIIT)

Moderate Intensity Continuous Training program (MICT)

HIIT + Resistance Training program (RT)

Arm Description

Subjects perform three sessions of training during 12 weeks: 35 min at 50% maximal aerobic power on bicycle.

Subjects perform three sessions of training during 12 weeks: repeated cycles of sprinting for 8s and pedaling slowly for 12s (between 20 and 30 rpm) for a maximum of 60 repeats per session.

Subjects perform three sessions of training during 12 weeks: Each subject performed HIIT protocol and then a single set of 8 exercises with 1 ou 2min resting period between exercises. Each set consisted of 8-12 repetitions at about 80% maximum repetition.

Outcomes

Primary Outcome Measures

Change from baseline abdominal fat mass (g) after 3 months of training (T3-T0/T0 x 100)
Total abdominal fat mass will be measured in all patients using DEXA based on the methodology of Martin and Jensen (1991; L1-L2 to pubic rami) before (baseline, T0) and after 3 months of training (T3).

Secondary Outcome Measures

Lipids oxidation evaluated by gas exchange measurements
Evolution of lipids oxidation at rest and during prolonged moderate intensity (40min, 50% of VO2max) using an automated gas analysis system. Carbon dioxide (CO2) production and oxygen consumption (CO2) are expressed in L/min. Respiratory exchange ratio is the ratio between CO2 production and O2 consumption (RER = VCO2/VO2).
Visceral fat mass
Change from baseline in visceral fat mass (g) (estimated from DEXA)
Total fat mass
Change from baseline in total fat mass (g) (determined from DEXA)
Fat-free mass
Change from baseline in total fat-free mass (g) (determined from DEXA)
Plasma HbA1c
Change from baseline in plasma HbA1c
Glucose level
Change from baseline in plasma glucose measurement
Plasma triglycerides
Change from baseline in plasma triglycerides
Plasma total cholesterol
Change from baseline in total cholesterol
Plasma HDL-cholesterol
Change from baseline in HDL-cholesterol
Plasma LDL-cholesterol
Change from baseline in LDL-cholesterol
Insulin level
Change from baseline in plasma insulin measurement

Full Information

First Posted
November 13, 2017
Last Updated
August 9, 2018
Sponsor
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
Collaborators
CREPS Vichy Auvergne, University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT03357016
Brief Title
HIIT Versus MICT on Abdominal Fat Mass and Lipid Oxidation in Postmenopausal Women (MATISSE)
Acronym
MATISSE
Official Title
Effect of High-Intensity Interval Training and Moderate-Intensity Continuous Training on Abdominal Fat Mass and Energy Substrates Utilization in Postmenopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
June 8, 2018 (Actual)
Study Completion Date
June 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
Collaborators
CREPS Vichy Auvergne, University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Postmenopausal women, as men, are more prone to central or android obesity than premenopausal women. Abdominal fat mass accumulation is associated with an increase of cardiovascular disease (CVD) risk. Most exercise programs designed for weight loss have focused on about 30 min several times per week of moderate intensity continuous training (MICT). Disappointingly, such exercise programs have led to either none or low fat loss. Accumulating evidence suggests that high intensity interval training (HIIT) should be an effective exercise protocol for reducing body fat of overweight individuals, especially at the abdominal level. Resistance Training (RT) is associated with increased muscle mass and strength gain in main muscles groups. Thus, RT seems to be an interesting strategy to fight against deconditioning and autonomy loss with age. Development of muscle mass enhances resting metabolism rate. Thus, RT could raise daily energy expenditure ie. substrates' oxidation including lipids. The aim of our study was to compare the effects of a 12-week moderate intensity continuous training (MICT) program with high intensity interval training (HIIT) program combined or not with a resistance training (RT) program on total abdominal and visceral fat mass and substrate utilization in postmenopausal women. It is hypothesized that HIIT compared to MICT program would result in significantly greater whole body and regional fat mass losses (abdominal and visceral) and would improve lipid oxidation at rest and during prolonged moderate exercise. It is also hypothesized that HIIT associated with RT could be the best strategy to reduce fat mass.
Detailed Description
Overweight and obesity are dramatically spreading worldwide, and these trends are occurring in both developed and developing countries. Fat mass and more particularly abdominal fat mass is related to the development of cardio-vascular diseases (CVD). Postmenopausal women, as men, are more prone to central or android obesity. Most exercise programs designed for weight loss have focused on about 30 min several times a week of moderate intensity continuous training (MICT). Disappointingly, such exercise programs have led to either none or low fat losses. Accumulating evidence suggests that high intensity interval training (HIIT) could be an effective exercise protocol for reducing adipose tissue of overweight individuals, especially at the abdominal level. HIIT involves brief high-intensity, anaerobic exercise followed by brief but slightly longer bouts of very low-intensity exercise. Resistance training (RT) program are currently proposed in order to reduce fat mass / preserve fat-free mass. Their beneficial effects have been demonstrated, especially in the elderly. Through development (or maintenance) of muscle mass, RT increases resting metabolism rate, daily energy expenditure, and substrate (fatty acids) oxidation. The aim of the study was to compare the effects of a 12-week moderate intensity continuous training (MICT) program with high intensity interval training (HIIT) combined or not with resistance training (RT) program on total, abdominal and visceral fat mass and substrate utilization at rest and during exercise in postmenopausal women. 36 postmenopausal women will be randomly assigned to MICT (n= 12) or HIIT (n= 12) or HIIT + RT (n= 12) group. Subjects performed three sessions per week during 12 weeks, on bicycle. MICT: For the MICT protocol, each subject performed 35 min at 50% maximal aerobic power (MAP). HIIT: For the HIIT protocol, each subject performed repeated cycles of sprinting for 8 s and pedaling slowly for 12 s (between 20 and 30 rpm) for a maximum of 60 repeats per session. HIIT+RT: For the HIIT+RT protocol, each subject performed HIIT protocol. Then they performed a single set of 8 exercises with 1 or 2min resting period between exercises. Each set consisted of 8-12 repetitions at about 80% maximum repetition (MR). Total body and regional fat content will be measured using dual-energy x-ray absorptiometry (DEXA) before and after the intervention (3 months). The investigators will examine the effects of HIIT, MICT and HIIT + RT programs on: Total fat mass (and appendicular fat mass) (DEXA) Total fat free mass (and appendicular fat free mass) (DEXA) Glycemic profile (plasma HbA1c, plasma glucose) Lipid profile (TG, HDL, LDL, total cholesterol) Substrates oxidation at rest and during moderate exercise (40min, 50% of maximal oxygen consumption VO2 max) Statistical analysis Appropriate sample size has been calculated given previous results about fat mass loss during HIIT in women and considering the dropouts observed in this type of protocol. Gaussian distribution of the data will be tested by the Kolmogorov-Smirnov test. Data will be presented as mean ± standard deviation (SD). Comparisons between groups will be made with Mann & Whitney U test or ANOVA when appropriate. Relationships between data will be assessed by Pearson correlation. Significance will be accepted at the p<0.05 level. Statistical procedures will be performed using Statistica software.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Post Menopausal Women
Keywords
interval training, abdominal fat mass, postmenopausal women, lipids oxidation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Data collected on the volunteers will be made anonymous.
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Intensity Interval Training program (HIIT)
Arm Type
Experimental
Arm Description
Subjects perform three sessions of training during 12 weeks: 35 min at 50% maximal aerobic power on bicycle.
Arm Title
Moderate Intensity Continuous Training program (MICT)
Arm Type
Experimental
Arm Description
Subjects perform three sessions of training during 12 weeks: repeated cycles of sprinting for 8s and pedaling slowly for 12s (between 20 and 30 rpm) for a maximum of 60 repeats per session.
Arm Title
HIIT + Resistance Training program (RT)
Arm Type
Experimental
Arm Description
Subjects perform three sessions of training during 12 weeks: Each subject performed HIIT protocol and then a single set of 8 exercises with 1 ou 2min resting period between exercises. Each set consisted of 8-12 repetitions at about 80% maximum repetition.
Intervention Type
Other
Intervention Name(s)
Training programs
Intervention Description
High Intensity Interval Training program (HIIT) vs. Moderate Intensity Continuous Training program (MICT) vs. High Intensity Interval Training program + Resistance Training program (HIIT+RT)
Primary Outcome Measure Information:
Title
Change from baseline abdominal fat mass (g) after 3 months of training (T3-T0/T0 x 100)
Description
Total abdominal fat mass will be measured in all patients using DEXA based on the methodology of Martin and Jensen (1991; L1-L2 to pubic rami) before (baseline, T0) and after 3 months of training (T3).
Time Frame
Baseline T0, 3 months after protocol starting
Secondary Outcome Measure Information:
Title
Lipids oxidation evaluated by gas exchange measurements
Description
Evolution of lipids oxidation at rest and during prolonged moderate intensity (40min, 50% of VO2max) using an automated gas analysis system. Carbon dioxide (CO2) production and oxygen consumption (CO2) are expressed in L/min. Respiratory exchange ratio is the ratio between CO2 production and O2 consumption (RER = VCO2/VO2).
Time Frame
1 week, 3 months after protocol starting
Title
Visceral fat mass
Description
Change from baseline in visceral fat mass (g) (estimated from DEXA)
Time Frame
Baseline T0, 3 months after protocol starting
Title
Total fat mass
Description
Change from baseline in total fat mass (g) (determined from DEXA)
Time Frame
Baseline T0, 3 months after protocol starting
Title
Fat-free mass
Description
Change from baseline in total fat-free mass (g) (determined from DEXA)
Time Frame
Baseline T0, 3 months after protocol starting
Title
Plasma HbA1c
Description
Change from baseline in plasma HbA1c
Time Frame
Baseline T0, 3 months after protocol starting
Title
Glucose level
Description
Change from baseline in plasma glucose measurement
Time Frame
Baseline T0, 3 months after protocol starting
Title
Plasma triglycerides
Description
Change from baseline in plasma triglycerides
Time Frame
Baseline T0, 3 months after protocol starting
Title
Plasma total cholesterol
Description
Change from baseline in total cholesterol
Time Frame
Baseline T0, 3 months after protocol starting
Title
Plasma HDL-cholesterol
Description
Change from baseline in HDL-cholesterol
Time Frame
Baseline T0, 3 months after protocol starting
Title
Plasma LDL-cholesterol
Description
Change from baseline in LDL-cholesterol
Time Frame
Baseline T0, 3 months after protocol starting
Title
Insulin level
Description
Change from baseline in plasma insulin measurement
Time Frame
Baseline T0, 3 months after protocol starting

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
82 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Postmenopausal women (55- 82 years) BMI ≥ 25 and < 40 Able to follow an exercise protocol Eating behavior and physical activity stable since at least 3 month Exclusion Criteria: Subject not able to perform exercise after medical examination Subject not able to perform bicycle exercise (pains) Chronic infection Use of β-blocker Medical treatment that could interfere with the different outcome measures Hormonal Replacement Therapy (HRT) Regular consumption of alcohol Refusal to sign the consent form
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martine Duclos, Pr
Organizational Affiliation
CHRU Gabriel Montpied Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CREPS Vichy Auvergne
City
Bellerive-sur-Allier
ZIP/Postal Code
03321
Country
France

12. IPD Sharing Statement

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HIIT Versus MICT on Abdominal Fat Mass and Lipid Oxidation in Postmenopausal Women (MATISSE)

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