Effects of Probiotic and HIIT in Obese Women

February 22, 2024 updated by: Chien-Wen Hou, University of Taipei

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

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Taipei, Taiwan
        • University of Taipei

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo control (C)
The subjects do not perform HIIT training, but consume one placebo packet every day on a fasting status for 8 weeks.
Yeast powder replaces probiotics in each packet. Each participant consume one packet every day on a fasting status for 8 weeks.
Experimental: Probiotics supplementation (P)
Each participant consume one probiotic packet every day on a fasting status for 8 weeks.
Probiotics, Lactiplantibacillus plantarum TWK10, are packaged in powder form. Each participant consume one packet every day on a fasting status for 8 weeks.
Experimental: HIIT intervention (H)
HIIT training for 3 sessions per week and consume one placebo packet every day on a fasting status for 8 weeks.
Yeast powder replaces probiotics in each packet. Each participant consume one packet every day on a fasting status for 8 weeks.
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.
Experimental: HIIT with probiotics intervention (HP)
Conduct HIIT training 3 sessions per week for 8 weeks and consume one probiotic packet every day on a fasting status for 8 weeks.
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Height
Time Frame: 8 weeks
Height in centimeters
8 weeks
Body weight
Time Frame: 8 weeks
Weight in kilograms
8 weeks
Body mass index (BMI)
Time Frame: 8 weeks
Calculated by: weight (kg)/ height (m^2)
8 weeks
Body fat percentage
Time Frame: 8 weeks
Body fat percentage (%) is measured with Dual-energy X-ray absorptiometry (DEXA)
8 weeks
Waist circumference
Time Frame: 8 weeks
Waist circumference in centimeters
8 weeks
Hip circumference
Time Frame: 8 weeks
Hip circumference in centimeters
8 weeks
Maximum oxygen uptake (VO2max)
Time Frame: 8 weeks
VO2max in ml/min/kg
8 weeks
Time to exhaustion (TTE)
Time Frame: 8 weeks
TTE in seconds
8 weeks
Running economy (RE)
Time Frame: 8 weeks
RE in ml/kg/km
8 weeks
Fasting blood glucose (FBG)
Time Frame: 8 weeks
FBG in mg/dL
8 weeks
Total cholesterol (TC)
Time Frame: 8 weeks
TC in mg/dL
8 weeks
Triglyceride (TG)
Time Frame: 8 weeks
TG in mg/dL
8 weeks
High-density lipoprotein cholesterol (HDL-C)
Time Frame: 8 weeks
HDL-C in mg/dL
8 weeks
Low-density lipoprotein cholesterol (LDL-C)
Time Frame: 8 weeks
LDL-C in mg/dL
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle mass
Time Frame: 8 weeks
Muscle mass in kilograms is measured with DEXA
8 weeks
Fat mass
Time Frame: 8 weeks
Fat mass in kilograms is measured with DEXA
8 weeks
Bone mineral density (BMD)
Time Frame: 8 weeks
BMD in g/cm^2 is measured with DEXA
8 weeks
Caloric intake
Time Frame: 8 weeks
Caloric intake in kcal/day
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Chien-Wen Hou, Ph.D., University of Taipei

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

January 31, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

February 13, 2024

First Submitted That Met QC Criteria

February 22, 2024

First Posted (Estimated)

February 29, 2024

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • MOST 107-2410-H-277-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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