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12-Month Once-a-week HIIT Improves Body Adiposity and Liver Fat

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ClinicalTrials.gov Identifier: NCT03912272
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Parco M. Siu, PhD, The University of Hong Kong

Brief Summary:
Obesity and non-alcoholic fatty liver disease (NAFLD) are two related growing epidemics that are becoming pressing public health concerns. High-intensity interval training (HIIT) is a promising cost-effective and time-efficient exercise modality for managing obesity and NAFLD. However, patients with obesity and NAFLD are generally inactive and unfit, and might feel intimidated by the frequency of the prescribed HIIT (conventionally three times weekly). Previous HIIT studies, mostly over 2-4 month periods, showed that the participants could accomplish this exercise frequency under a controlled laboratory environment, but the long-term adherence and sustainability, especially in a field setting, remains uncertain. The situation is more unclear if we also consider those individuals who refused to participate possibly because of their overwhelming perceptions or low self-efficacy toward HIIT. Thus, logically, HIIT at a lower frequency would be practical and more suitable for patients with obesity and NAFLD, but the minimum exercise frequency required to improve health, especially in the long-term, is unknown. This proposed study aims to examine the effectiveness of long-term low-frequency HIIT for improving body adiposity and liver fat in centrally obese adults. The premise of this proposal is supported by recent findings that HIIT performed once a week could improve cardiorespiratory fitness, blood pressure, cardiac morphology, metabolic capacity, muscle power, and lean mass. This study will provide evidence for the benefits of long-term low-frequency HIIT with a follow-up period to assess its effectiveness, safety, adherence, and sustainability. We expect this intervention will enhance the practical suitability of HIIT in inactive obese adults and will provide evidence for low-frequency HIIT as a new exercise option in the management of obesity and NAFLD.

Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Central Obesity Behavioral: High-intensity Interval Training Behavioral: Usual Care Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effectiveness of Long-term Low-frequency High-Intensity Interval Training (HIIT) to Improve Body Adiposity and Liver Fat in Adults With Central Obesity: A Randomized Controlled Trial
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023


Arm Intervention/treatment
Placebo Comparator: Usual Care Control
Subjects in the usual care control group will receive a health education programme. This programme includes 12-month twice-a-month sessions (70 minutes each session) for obesity-related health briefing, dietary caloric restriction advice, and lifestyle counseling/consultation. The same health information will be delivered to the subjects in the HIIT group throughout the 12-month intervention period. Subjects will be asked to attend >70% of the classes.
Behavioral: Usual Care Control
In the usual care control group, obesity-related health briefing, dietary caloric restriction advice, and lifestyle counseling/consultation will be provided.

Experimental: High-intensity Interval Training Group
HIIT will be prescribed once weekly under the supervision of certified athletics coaches for 12 months. HIIT training will be performed in a small group (~10) in an open field setting. In each session, subjects will run for four 4-minute intervals at 85%-95% of the peak heart rate (HRpeak) with a 3-minute active recovery at 50%-70% of the HRpeak between each interval. A 5-minute jog at an intensity of 70% of the HRpeak will be included for warm-up and cool-down before and after, respectively. Subjects will be asked to attend >70% of the classes.
Behavioral: High-intensity Interval Training
In the high-intensity interval training group, subjects will receive respective prescribed exercise once a week.




Primary Outcome Measures :
  1. Liver Fat [ Time Frame: Change from baseline amount of intrahepatic triglycerides content at 12 months ]
    Intrahepatic triglycerides will be examined by 1H-MR spectroscopy in a 3×3×3 cm voxel using a Philips Achieva 3.0T system housed at the MR imaging unit of HKU core facility. A trained MRI radiographer will operate the machine, position the subjects and analyze the results. NAFLD will be defined as >5% intrahepatic triglycerides assessed by 1H-MR spectroscopy.

  2. Body Adiposity [ Time Frame: Change from baseline amount of body fat mass triglycerides at 12 months ]
    Total body fat mass will be determined using a full body dual-energy X-ray absorptiometry (DXA) scanner (Explorer S/N 91075, Hologic Inc., Waltham, USA). A trained technician will operate the DXA machine, position the subjects and analyze the results. The typical coefficients of variation of the DXA scanner for each body compartment from duplicate analyses are 0.4% for lean mass, 1.4% for fat mass and 1.0% for bone mass


Secondary Outcome Measures :
  1. Visceral Adiposity [ Time Frame: Baseline measurement (2019.01.01); All assessments will be repeated at 12 months post-intervention (2020.01.01) and at 24 months at the follow-up(2022.01.01) ]
    Abdominal visceral fat will be measured at the L4-L5 junction using a three-point Dixon sequence using a Philips Achieva 3.0T system housed at the MR imaging unit of HKU core facility. A trained MRI radiographer will operate the machine, position the subjects and analyze the results.

  2. Body Mass Index [ Time Frame: Baseline measurement (2019.01.01); All assessments will be repeated at 12 months post-intervention (2020.01.01) and at 24 months at the follow-up(2022.01.01) ]
    A calibrated electronic digital weighing scale (BC418, Tanita, Japan) with a 200 kg capacity and ± 0.05 kg accuracy will be used to weigh the subjects. A stadiometer (Holtain Ltd., UK) with 200 cm limit and ± 0.01 cm accuracy will be used to measure body height. Then BMI will be calculated from the body weight and height.

  3. Waist Circumference [ Time Frame: Baseline measurement (2019.01.01); All assessments will be repeated at 12 months post-intervention (2020.01.01) and at 24 months at the follow-up(2022.01.01) ]
    Waist circumference will be measured on bare skin midway between the lowest rib and the superior border of the iliac crest using an inelastic measuring tape to the nearest 0.1 cm. Measurement will be performed at the end of normal expiration.

  4. VO2max [ Time Frame: Baseline measurement (2019.01.01); All assessments will be repeated at 12 months post-intervention (2020.01.01) and at 24 months at the follow-up(2022.01.01) ]
    VO2max test will be conducted using a calibrated motor-driven treadmill (LE500C, Jaeger, Germany) by continuous metabolic VO2 measurement using a Cosmed K5 portable telemetric gas analysis system. The test will be performed using a ramp protocol where the speed will be constant and the incline will be increased by 2% every second minute until VO2max is reached. Capillary blood will be obtained before and immediately after the test for the blood lactate analysis. The highest value of VO2 which meets one of the following criteria will be considered as the VO2max: 1) plateau of VO2 with increasing intensity, 2) respiratory exchange ratio (RER) ≥1.05, and 3) post-exercise blood lactate exceeding 8 mmol/L.

  5. VO2 [ Time Frame: Baseline measurement (2019.01.01); All assessments will be repeated at 12 months post-intervention (2020.01.01) and at 24 months at the follow-up(2022.01.01) ]
    VO2 will be continuously recorded during the VO2max test.

  6. Borg Rate of Perceived exertion (RPE) [ Time Frame: Baseline measurement (2019.01.01); All assessments will be repeated at 12 months post-intervention (2020.01.01) and at 24 months at the follow-up(2022.01.01) ]
    RPE will be continuously recorded during the VO2max test

  7. Heart Rate [ Time Frame: Baseline measurement (2019.01.01); All assessments will be repeated at 12 months post-intervention (2020.01.01) and at 24 months at the follow-up(2022.01.01) ]
    Heart rate will be continuously recorded during the VO2max test.

  8. Blood Pressure [ Time Frame: Baseline measurement (2019.01.01); All assessments will be repeated at 12 months post-intervention (2020.01.01) and at 24 months at the follow-up(2022.01.01) ]
    Subjects will abstain from consuming caffeine and alcohol at least 10 hours prior to the assessment. After 10 minutes rest in the seated position, blood pressure will be measured on the right arm using a blood pressure monitor (M3 Vital Signs Monitor, EDAN). Systolic and diastolic blood pressure and mean arterial pressure will be obtained over the brachial artery region with the arm supported at the heart level using an appropriately sized cuff. Measurements will be repeated after 10 minutes and the average of two separate measurements will be recorded for the analysis.

  9. Lean Mass [ Time Frame: Baseline measurement (2019.01.01); All assessments will be repeated at 12 months post-intervention (2020.01.01) and at 24 months at the follow-up(2022.01.01) ]
    Total body lean mass will be determined by using DXA scan.

  10. Bone Mineral Density [ Time Frame: Baseline measurement (2019.01.01); All assessments will be repeated at 12 months post-intervention (2020.01.01) and at 24 months at the follow-up(2022.01.01) ]
    Bone mineral density will be determined by using DXA scan.

  11. Fasting glucose [ Time Frame: Baseline measurement (2019.01.01); All assessments will be repeated at 12 months post-intervention (2020.01.01) and at 24 months at the follow-up(2022.01.01) ]
    Subjects will fast overnight for 10 hours. Subjects will sit in a quiet environment for 15 minutes prior to blood collection. Venous blood will be drawn from an antecubital vein in the forearm by a certified phlebotomist and sent to an accredited medical laboratory to measure the level of fasting glucose.

  12. Insulin [ Time Frame: Baseline measurement (2019.01.01); All assessments will be repeated at 12 months post-intervention (2020.01.01) and at 24 months at the follow-up(2022.01.01) ]
    Subjects will fast overnight for 10 hours. Subjects will sit in a quiet environment for 15 minutes prior to blood collection. Venous blood will be drawn from an antecubital vein in the forearm by a certified phlebotomist and sent to an accredited medical laboratory to measure the level of insulin.

  13. HbA1c [ Time Frame: Baseline measurement (2019.01.01); All assessments will be repeated at 12 months post-intervention (2020.01.01) and at 24 months at the follow-up(2022.01.01) ]
    Subjects will fast overnight for 10 hours. Subjects will sit in a quiet environment for 15 minutes prior to blood collection. Venous blood will be drawn from an antecubital vein in the forearm by a certified phlebotomist and sent to an accredited medical laboratory to measure the level of HbA1c.

  14. Alanine aminotransferase ALT [ Time Frame: Baseline measurement (2019.01.01); All assessments will be repeated at 12 months post-intervention (2020.01.01) and at 24 months at the follow-up(2022.01.01) ]
    Subjects will fast overnight for 10 hours. Subjects will sit in a quiet environment for 15 minutes prior to blood collection. Venous blood will be drawn from an antecubital vein in the forearm by a certified phlebotomist and sent to an accredited medical laboratory to measure the level of ALT.

  15. Aspartate aminotransferase AST [ Time Frame: Baseline measurement (2019.01.01); All assessments will be repeated at 12 months post-intervention (2020.01.01) and at 24 months at the follow-up(2022.01.01) ]
    Subjects will fast overnight for 10 hours. Subjects will sit in a quiet environment for 15 minutes prior to blood collection. Venous blood will be drawn from an antecubital vein in the forearm by a certified phlebotomist and sent to an accredited medical laboratory to measure the level of AST.

  16. LDL cholesterol [ Time Frame: Baseline measurement (2019.01.01); All assessments will be repeated at 12 months post-intervention (2020.01.01) and at 24 months at the follow-up(2022.01.01) ]
    Subjects will fast overnight for 10 hours. Subjects will sit in a quiet environment for 15 minutes prior to blood collection. Venous blood will be drawn from an antecubital vein in the forearm by a certified phlebotomist and sent to an accredited medical laboratory to measure the level of LDL cholesterol.

  17. HDL cholesterol [ Time Frame: Baseline measurement (2019.01.01); All assessments will be repeated at 12 months post-intervention (2020.01.01) and at 24 months at the follow-up(2022.01.01) ]
    Subjects will fast overnight for 10 hours. Subjects will sit in a quiet environment for 15 minutes prior to blood collection. Venous blood will be drawn from an antecubital vein in the forearm by a certified phlebotomist and sent to an accredited medical laboratory to measure the level of HDL cholesterol.

  18. Total cholesterol [ Time Frame: Baseline measurement (2019.01.01); All assessments will be repeated at 12 months post-intervention (2020.01.01) and at 24 months at the follow-up(2022.01.01) ]
    Subjects will fast overnight for 10 hours. Subjects will sit in a quiet environment for 15 minutes prior to blood collection. Venous blood will be drawn from an antecubital vein in the forearm by a certified phlebotomist and sent to an accredited medical laboratory to measure the level of total cholesterol.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Cantonese, Mandarin or English speaking,
  2. Aged 18-60,
  3. Central obesity, defined as BMI ≥25 (obesity classification adopted by the Hong Kong Government) with waist circumference of ≥90 cm for men and ≥80 cm for women (abdominal obesity according to the International Diabetes Federation's Chinese ethnic-specific criterion),
  4. Willing to initiate lifestyle modification but not pharmacologic or surgical means for treating obesity.

Exclusion criteria:

  1. ≥150 minutes moderate-intensity exercise or ≥75 minutes vigorous exercise weekly,
  2. Regular HIIT (≥1 weekly) in the past six months,
  3. Medical history of cardiovascular disease, chronic pulmonary or kidney disease, heart failure, cancer, and liver disease except for NAFLD,
  4. Somatic conditions that limit exercise participation (e.g., limb loss),
  5. Impaired mobility due to chronic diseases (e.g., chronic arthritis/osteoarthritis, neurological, musculoskeletal and autoimmune diseases),
  6. Daily smoking habit,
  7. Excess alcohol consumption (daily ≥30 g of alcohol for men and ≥20 g for women) in the past six months
  8. Surgery, therapy or medication for obesity or weight loss in the past 6 months (e.g., gastric bypass, gastric band, sleeve gastrectomy, gastric reduction duodenal switch, and dietitian-prescribed dietary program).
  9. During the study period, subjects identified with major physical changes that would considerably affect their body composition and weight (e.g., anorexia nervosa, bulimia nervosa, and prolonged gastrointestinal and digestive disorders) will be excluded.

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): NCT03912272


Contacts
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Contact: JUCHENG YU 97561053 dannyu@connect.hku.hk
Contact: PARCO,MING FAI SIU, PhD pmsiu@hku.hk

Locations
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Hong Kong
Li Ka Shing Faculty of Medicine Recruiting
Hong Kong, Hong Kong
Contact: JUCHENG YU, PhD Student    28315291      
Contact    97561053    dannyu@connect.hku.hk   
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: PARCO,MING FAI SIU, PhD The University of Hong Kong

Publications:
Siu PM. Efficacy of Tai Chi training to alleviate insomnia in older adults. Proceeding of The 6th International Conference on Nutrition and Physical Activity (NAPA 2015), Taipei, Taiwan 2015;p.59
Siu PM, Yu AP, Yu DS, Hui SS, Woo J. Effectiveness of Tai Chi training to alleviate metabolic syndrome in abdominal obese older adults: A randomized controlled trial.
Siu PM, Yu AP, Yu DS, Hui SS, Woo J. Effects of Tai Chi Exercise on Cardiometabolic Health and Muscle Content. Proceeding of the 3rd Asian Conference for Frailty and Sarcopenia, Seoul, Korea 2017
Siu PM, Chin EC, Wong SH, Fong DY, Chan DK, Ngai HH, Lee CH, Yung PS. Low-frequency high-intensity interval training (HIIT) improves cardiorespiratory fitness and body composition in overweight adults. Med Sci Sports Exerc 2018:abstract submitted to the 65th American College of Sports Medicine (ACSM) Annual Meeting.

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Responsible Party: Parco M. Siu, PhD, Associate Professor and Division Head, Division of Kinesiology, School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03912272     History of Changes
Other Study ID Numbers: RF-9835-NAFLD-001
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient data can be shared upon request. Personal data such as name, and phone number will be blinded.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: Data will be available for a year after the study is finished and published.
Access Criteria: Only for Academic use with proof of need.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Parco M. Siu, PhD, The University of Hong Kong:
Long-Term Low-Frequency High-Intensity Interval Training
Non-Alcoholic Fatty Liver Disease
Central Obesity
Body Adiposity
Liver Fat
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Obesity
Obesity, Abdominal
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Digestive System Diseases
Liver Extracts
Hematinics