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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06285578
Other study ID # MOST 107-2410-H-277-003
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2018
Est. completion date March 1, 2019

Study information

Verified date February 2024
Source University of Taipei
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date March 1, 2019
Est. primary completion date January 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 35 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Probiotics supplementation
Probiotics, Lactiplantibacillus plantarum TWK10, are packaged in powder form. Each participant consume one packet every day on a fasting status for 8 weeks.
Behavioral:
HIIT training
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.
Dietary Supplement:
Placebo supplementation
Yeast powder replaces probiotics in each packet. Each participant consume one packet every day on a fasting status for 8 weeks.

Locations

Country Name City State
Taiwan University of Taipei Taipei

Sponsors (1)

Lead Sponsor Collaborator
University of Taipei

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Height Height in centimeters 8 weeks
Primary Body weight Weight in kilograms 8 weeks
Primary Body mass index (BMI) Calculated by: weight (kg)/ height (m^2) 8 weeks
Primary Body fat percentage Body fat percentage (%) is measured with Dual-energy X-ray absorptiometry (DEXA) 8 weeks
Primary Waist circumference Waist circumference in centimeters 8 weeks
Primary Hip circumference Hip circumference in centimeters 8 weeks
Primary Maximum oxygen uptake (VO2max) VO2max in ml/min/kg 8 weeks
Primary Time to exhaustion (TTE) TTE in seconds 8 weeks
Primary Running economy (RE) RE in ml/kg/km 8 weeks
Primary Fasting blood glucose (FBG) FBG in mg/dL 8 weeks
Primary Total cholesterol (TC) TC in mg/dL 8 weeks
Primary Triglyceride (TG) TG in mg/dL 8 weeks
Primary High-density lipoprotein cholesterol (HDL-C) HDL-C in mg/dL 8 weeks
Primary Low-density lipoprotein cholesterol (LDL-C) LDL-C in mg/dL 8 weeks
Secondary Muscle mass Muscle mass in kilograms is measured with DEXA 8 weeks
Secondary Fat mass Fat mass in kilograms is measured with DEXA 8 weeks
Secondary Bone mineral density (BMD) BMD in g/cm^2 is measured with DEXA 8 weeks
Secondary Caloric intake Caloric intake in kcal/day 8 weeks
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