- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06285578
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
Status
Completed
Conditions
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.
Sponsor
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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