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Completed

NCT Number: NCT06285578

Effects of Probiotic and HIIT in Obese Women

The aim of this study is to investigate whether there are the additive effects when implementing both high-intensity interval training (HIIT) and probiotics simultaneously on improving cardiorespiratory endurance and metabolism in middle-aged women.

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Key information

Conditions

Cardiorespiratory Fitness Anthropometry Metabolism

Age range

35 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Taipei

Taipei, Taiwan

About this study

High-intensity interval training (HIIT) is a time-efficiency exercise mode that has been shown to reduce body fat, fasting blood insulin levels, arterial stiffness, and aerobic capacity, helping to prevent and improve chronic diseases. Probiotics, on the other hand, have been found to have similar effects, including improving insulin sensitivity and endurance exercise performance, as well as reducing body fat. However, the additive effects of HIIT combined with probiotic supplements are unclear. In addition, on average, the life expectancy of women is longer than that of men. Middle-aged women are at high-risk for obesity and metabolic-related problems that threaten their long-term health. Therefore, whether the combination of HIIT and probiotics can be utilized to enhance the wellness of middle-aged women is the objective of this study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female
  • Age between 35-55 years old
  • Total body fat percentage greater than 30%

Exclusion criteria

  • Male
  • Participants who were taking probiotics supplementation or antibiotics
  • Percentage of total body fat less than 30%

Treatment and study plan

probiotics supplementation

Dietary Supplement

Probiotics, Lactiplantibacillus plantarum TWK10, are packaged in powder form. Each participant consume one packet every day on a fasting status for 8 weeks.

HIIT training

Behavioral

HIIT training is conduct at the intensity of 85-90% VO2max for 2 minutes with 1-minute inactive resting interval, repeating for 7 times. 3 sessions per week for 8 weeks.

Placebo supplementation

Dietary Supplement

Yeast powder replaces probiotics in each packet. Each participant consume one packet every day on a fasting status for 8 weeks.

Primary outcomes

  1. Height

    Time frame: 8 weeks

    Height in centimeters

  2. Body weight

    Time frame: 8 weeks

    Weight in kilograms

  3. Body mass index (BMI)

    Time frame: 8 weeks

    Calculated by: weight (kg)/ height (m^2)

  4. Body fat percentage

    Time frame: 8 weeks

    Body fat percentage (%) is measured with Dual-energy X-ray absorptiometry (DEXA)

  5. Waist circumference

    Time frame: 8 weeks

    Waist circumference in centimeters

  6. Hip circumference

    Time frame: 8 weeks

    Hip circumference in centimeters

  7. Maximum oxygen uptake (VO2max)

    Time frame: 8 weeks

    VO2max in ml/min/kg

  8. Time to exhaustion (TTE)

    Time frame: 8 weeks

    TTE in seconds

  9. Running economy (RE)

    Time frame: 8 weeks

    RE in ml/kg/km

  10. Fasting blood glucose (FBG)

    Time frame: 8 weeks

    FBG in mg/dL

  11. Total cholesterol (TC)

    Time frame: 8 weeks

    TC in mg/dL

  12. Triglyceride (TG)

    Time frame: 8 weeks

    TG in mg/dL

  13. High-density lipoprotein cholesterol (HDL-C)

    Time frame: 8 weeks

    HDL-C in mg/dL

  14. Low-density lipoprotein cholesterol (LDL-C)

    Time frame: 8 weeks

    LDL-C in mg/dL

Secondary outcomes

  1. Muscle mass

    Time frame: 8 weeks

    Muscle mass in kilograms is measured with DEXA

  2. Fat mass

    Time frame: 8 weeks

    Fat mass in kilograms is measured with DEXA

  3. Bone mineral density (BMD)

    Time frame: 8 weeks

    BMD in g/cm^2 is measured with DEXA

  4. Caloric intake

    Time frame: 8 weeks

    Caloric intake in kcal/day

Sponsors and collaborators

Lead sponsor

University of Taipei

Other

Registry information

Official study title

Effects of Probiotic With HIIT on Cardiorespiratory Endurance and Metabolism in Middle-Aged Obese Women

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 29, 2024
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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