Cardiorespiratory FitnessNCT06285578
Effects of Probiotic and HIIT in Obese Women
A study testing Probiotics supplementation and HIIT training in people with Cardiorespiratory Fitness and Metabolism, run by University of Taipei at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 35 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiorespiratory Fitness, Metabolism, Anthropometry
- What is being tested?
- Probiotics supplementation and HIIT training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2018to 1 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Age between 35-55 years old
- Total body fat percentage greater than 30%
Who cannot join
- Male
- Participants who were taking probiotics supplementation or antibiotics
- Percentage of total body fat less than 30%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiorespiratory Fitness, Metabolism, Anthropometry
- Being tested
- Probiotics supplementation, HIIT training, Placebo supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics supplementationDietary 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 trainingBehavioural
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 supplementationDietary supplement
Yeast powder replaces probiotics in each packet. Each participant consume one packet every day on a fasting status for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo control (C) | Placebo comparator | The subjects do not perform HIIT training, but consume one placebo packet every day on a fasting status for 8 weeks. Receives: Dietary Supplement: Placebo supplementation |
| Probiotics supplementation (P) | Experimental | Each participant consume one probiotic packet every day on a fasting status for 8 weeks. Receives: Dietary Supplement: Probiotics supplementation |
| HIIT intervention (H) | Experimental | HIIT training for 3 sessions per week and consume one placebo packet every day on a fasting status for 8 weeks. Receives: Behavioral: HIIT training; Dietary Supplement: Placebo supplementation |
| HIIT with probiotics intervention (HP) | Experimental | Conduct HIIT training 3 sessions per week for 8 weeks and consume one probiotic packet every day on a fasting status for 8 weeks. Receives: Dietary Supplement: Probiotics supplementation; Behavioral: HIIT training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height
Height in centimeters
Measured: 8 weeks
Body weight
Weight in kilograms
Measured: 8 weeks
Body mass index (BMI)
Calculated by: weight (kg)/ height (m^2)
Measured: 8 weeks
Body fat percentage
Body fat percentage (%) is measured with Dual-energy X-ray absorptiometry (DEXA)
Measured: 8 weeks
Waist circumference
Waist circumference in centimeters
Measured: 8 weeks
Hip circumference
Hip circumference in centimeters
Measured: 8 weeks
Maximum oxygen uptake (VO2max)
VO2max in ml/min/kg
Measured: 8 weeks
Time to exhaustion (TTE)
TTE in seconds
Measured: 8 weeks
Running economy (RE)
RE in ml/kg/km
Measured: 8 weeks
Fasting blood glucose (FBG)
FBG in mg/dL
Measured: 8 weeks
Total cholesterol (TC)
TC in mg/dL
Measured: 8 weeks
Triglyceride (TG)
TG in mg/dL
Measured: 8 weeks
High-density lipoprotein cholesterol (HDL-C)
HDL-C in mg/dL
Measured: 8 weeks
Low-density lipoprotein cholesterol (LDL-C)
LDL-C in mg/dL
Measured: 8 weeks
Secondary outcomes (4)
Muscle mass
Muscle mass in kilograms is measured with DEXA
Measured: 8 weeks
Fat mass
Fat mass in kilograms is measured with DEXA
Measured: 8 weeks
Bone mineral density (BMD)
BMD in g/cm^2 is measured with DEXA
Measured: 8 weeks
Caloric intake
Caloric intake in kcal/day
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start1 Oct 2018
- Primary completion31 Jan 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiorespiratory FitnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Taipei
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chien-Wen Hou, University of Taipei
- Investigators
- Chien-Wen Hou, Ph.D., Study director, University of Taipei
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285578
- Sponsor's protocol ID
- MOST 107-2410-H-277-003
- Status last verified
- Feb 2024
- First submitted
- 13 Feb 2024
- Last updated
- 29 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen YC, Wang HY, Ogita F, Hung CH, Kuo CH, Wang JP, Wang CM, Hou CW, Wang TY. Effects of probiotic supplementation with high-intensity interval training on cardiorespiratory endurance and metabolism in Middle-Aged Obese Women. J Int Soc Sports Nutr. 2024 Dec;21(1):2425609. doi: 10.1080/15502783.2024.2425609. Epub 2024 Dec 1.
PubMed 39618097
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Probiotic With HIIT on Cardiorespiratory Endurance and Metabolism in Middle-Aged Obese Women
- ClinicalTrials.gov ID
- NCT06285578
- Acronym / sponsor ID
- MOST 107-2410-H-277-003
- Conditions
- Cardiorespiratory Fitness, Metabolism, Anthropometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of TaipeiUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo control (C) | Placebo comparator | Dietary Supplement: Placebo supplementationThe subjects do not perform HIIT training, but consume one placebo packet every day on a fasting status for 8 weeks. |
| Probiotics supplementation (P) | Experimental | Dietary Supplement: Probiotics supplementationEach participant consume one probiotic packet every day on a fasting status for 8 weeks. |
| HIIT intervention (H) | Experimental | Behavioral: HIIT training, Dietary Supplement: Placebo supplementationHIIT training for 3 sessions per week and consume one placebo packet every day on a fasting status for 8 weeks. |
| HIIT with probiotics intervention (HP) | Experimental | Dietary Supplement: Probiotics supplementation, Behavioral: HIIT trainingConduct HIIT training 3 sessions per week for 8 weeks and consume one probiotic packet every day on a fasting status for 8 weeks. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female
- Age between 35-55 years old
- Total body fat percentage greater than 30%
Key exclusion criteria (3 listed)
- Male
- Participants who were taking probiotics supplementation or antibiotics
- Percentage of total body fat less than 30%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotics supplementationProbiotics, Lactiplantibacillus plantarum TWK10, are packaged in powder form. Each participant consume one packet every day on a fasting status for 8 weeks. | Dietary supplement | HIIT with probiotics intervention (HP), Probiotics supplementation (P) |
| HIIT trainingHIIT 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. | Behavioural | HIIT intervention (H), HIIT with probiotics intervention (HP) |
| Placebo supplementationYeast powder replaces probiotics in each packet. Each participant consume one packet every day on a fasting status for 8 weeks. | Dietary supplement | HIIT intervention (H), Placebo control (C) |
Primary outcome
Height
Time frame: 8 weeks
Height in centimeters
Body weight
Time frame: 8 weeks
Weight in kilograms
Body mass index (BMI)
Time frame: 8 weeks
Calculated by: weight (kg)/ height (m^2)
Body fat percentage
Time frame: 8 weeks
Body fat percentage (%) is measured with Dual-energy X-ray absorptiometry (DEXA)
Waist circumference
Time frame: 8 weeks
Waist circumference in centimeters
Hip circumference
Time frame: 8 weeks
Hip circumference in centimeters
Maximum oxygen uptake (VO2max)
Time frame: 8 weeks
VO2max in ml/min/kg
Time to exhaustion (TTE)
Time frame: 8 weeks
TTE in seconds
Running economy (RE)
Time frame: 8 weeks
RE in ml/kg/km
Fasting blood glucose (FBG)
Time frame: 8 weeks
FBG in mg/dL
Total cholesterol (TC)
Time frame: 8 weeks
TC in mg/dL
Triglyceride (TG)
Time frame: 8 weeks
TG in mg/dL
High-density lipoprotein cholesterol (HDL-C)
Time frame: 8 weeks
HDL-C in mg/dL
Low-density lipoprotein cholesterol (LDL-C)
Time frame: 8 weeks
LDL-C in mg/dL
4 secondary outcomes
Muscle mass
Time frame: 8 weeks
Fat mass
Time frame: 8 weeks
Bone mineral density (BMD)
Time frame: 8 weeks
Caloric intake
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Derived from this study: PubMed 39618097Chen YC, Wang HY, Ogita F, Hung CH, Kuo CH, Wang JP, Wang CM, Hou CW, Wang TY. Effects of probiotic supplementation with high-intensity interval training on cardiorespiratory endurance and metabolism in Middle-Aged Obese Women. J Int Soc Sports Nutr. 2024 Dec;21(1):2425609. doi: 10.1080/15502783.2024.2425609. Epub 2024 Dec 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chien-Wen Hou, Ph.D. study director
University of Taipei
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics supplementation and HIIT training in people with Cardiorespiratory Fitness and Metabolism, run by University of Taipei at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Height (time frame: 8 weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06285578, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.