ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03357016
Recruitment Status : Recruiting
First Posted : November 29, 2017
Last Update Posted : December 6, 2017
Sponsor:
Collaborators:
CREPS Vichy Auvergne
University Hospital, Clermont-Ferrand
Information provided by (Responsible Party):
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques

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.


Condition or disease Intervention/treatment Phase
Overweight Post Menopausal Women Other: Training programs Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Data collected on the volunteers will be made anonymous.
Primary Purpose: Prevention
Official Title: Effect of High-Intensity Interval Training and Moderate-Intensity Continuous Training on Abdominal Fat Mass and Energy Substrates Utilization in Postmenopausal Women
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: High Intensity Interval Training program (HIIT)
Subjects perform three sessions of training during 12 weeks: 35 min at 50% maximal aerobic power on bicycle.
Other: Training programs
High Intensity Interval Training program (HIIT) vs. Moderate Intensity Continuous Training program (MICT) vs. High Intensity Interval Training program + Resistance Training program (HIIT+RT)

Experimental: Moderate Intensity Continuous Training program (MICT)
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.
Other: Training programs
High Intensity Interval Training program (HIIT) vs. Moderate Intensity Continuous Training program (MICT) vs. High Intensity Interval Training program + Resistance Training program (HIIT+RT)

Experimental: HIIT + Resistance Training program (RT)
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.
Other: Training programs
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 Measures :
  1. Change from baseline abdominal fat mass (g) after 3 months of training (T3-T0/T0 x 100) [ Time Frame: Baseline T0, 3 months after protocol starting ]
    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 :
  1. Lipids oxidation evaluated by gas exchange measurements [ Time Frame: 1 week, 3 months after protocol starting ]
    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).

  2. Visceral fat mass [ Time Frame: Baseline T0, 3 months after protocol starting ]
    Change from baseline in visceral fat mass (g) (estimated from DEXA)

  3. Total fat mass [ Time Frame: Baseline T0, 3 months after protocol starting ]
    Change from baseline in total fat mass (g) (determined from DEXA)

  4. Fat-free mass [ Time Frame: Baseline T0, 3 months after protocol starting ]
    Change from baseline in total fat-free mass (g) (determined from DEXA)

  5. Plasma HbA1c [ Time Frame: Baseline T0, 3 months after protocol starting ]
    Change from baseline in plasma HbA1c

  6. Glucose level [ Time Frame: Baseline T0, 3 months after protocol starting ]
    Change from baseline in plasma glucose measurement

  7. Plasma triglycerides [ Time Frame: Baseline T0, 3 months after protocol starting ]
    Change from baseline in plasma triglycerides

  8. Plasma total cholesterol [ Time Frame: Baseline T0, 3 months after protocol starting ]
    Change from baseline in total cholesterol

  9. Plasma HDL-cholesterol [ Time Frame: Baseline T0, 3 months after protocol starting ]
    Change from baseline in HDL-cholesterol

  10. Plasma LDL-cholesterol [ Time Frame: Baseline T0, 3 months after protocol starting ]
    Change from baseline in LDL-cholesterol

  11. Insulin level [ Time Frame: Baseline T0, 3 months after protocol starting ]
    Change from baseline in plasma insulin measurement



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years to 82 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03357016


Contacts
Contact: Nathalie Boisseau, Pr 0473405519 ext +33 Nathalie.boisseau@uca.fr

Locations
France
CREPS Vichy Auvergne Recruiting
Bellerive-sur-Allier, France, 03321
Contact: Nathalie Boisseau, Pr    0473405519 ext +33    Nathalie.boisseau@uca.fr   
Principal Investigator: Martine Duclos, Pr         
Sponsors and Collaborators
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
CREPS Vichy Auvergne
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Martine Duclos, Pr CHRU Gabriel Montpied Clermont-Ferrand

Responsible Party: Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
ClinicalTrials.gov Identifier: NCT03357016     History of Changes
Other Study ID Numbers: AU1303
2016-A01742-49 ( Registry Identifier: ANSM )
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017

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

Keywords provided by Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques:
interval training
abdominal fat mass
postmenopausal women
lipids oxidation

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms