NCT06285578

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 29, 2024

Completed
Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

4 months

First QC Date

February 13, 2024

Last Update Submit

February 22, 2024

Conditions

Cardiorespiratory FitnessMetabolismAnthropometry

Outcome Measures

Primary Outcomes (14)

  • Height

    Height in centimeters

    8 weeks

  • Body weight

    Weight in kilograms

    8 weeks

  • Body mass index (BMI)

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

    8 weeks

  • Body fat percentage

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

    8 weeks

  • Waist circumference

    Waist circumference in centimeters

    8 weeks

  • Hip circumference

    Hip circumference in centimeters

    8 weeks

  • Maximum oxygen uptake (VO2max)

    VO2max in ml/min/kg

    8 weeks

  • Time to exhaustion (TTE)

    TTE in seconds

    8 weeks

  • Running economy (RE)

    RE in ml/kg/km

    8 weeks

  • Fasting blood glucose (FBG)

    FBG in mg/dL

    8 weeks

  • Total cholesterol (TC)

    TC in mg/dL

    8 weeks

  • Triglyceride (TG)

    TG in mg/dL

    8 weeks

  • High-density lipoprotein cholesterol (HDL-C)

    HDL-C in mg/dL

    8 weeks

  • Low-density lipoprotein cholesterol (LDL-C)

    LDL-C in mg/dL

    8 weeks

Secondary Outcomes (4)

  • Muscle mass

    8 weeks

  • Fat mass

    8 weeks

  • Bone mineral density (BMD)

    8 weeks

  • Caloric intake

    8 weeks

Study Arms (4)

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.

Dietary Supplement: Placebo supplementation

Probiotics supplementation (P)

EXPERIMENTAL

Each participant consume one probiotic packet every day on a fasting status for 8 weeks.

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.

Behavioral: HIIT trainingDietary 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.

Dietary Supplement: Probiotics supplementationBehavioral: HIIT training

Interventions

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 with probiotics intervention (HP)Probiotics supplementation (P)
HIIT trainingBEHAVIORAL

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.

HIIT intervention (H)HIIT with probiotics intervention (HP)
Placebo supplementationDIETARY_SUPPLEMENT

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

HIIT intervention (H)Placebo control (C)

Eligibility Criteria

Age35 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Taipei

Taipei, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 39618097DERIVED

Study Officials

  • Chien-Wen Hou, Ph.D.

    University of Taipei

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

February 13, 2024

First Posted

February 29, 2024

Study Start

October 1, 2018

Primary Completion

January 31, 2019

Study Completion

March 1, 2019

Last Updated

February 29, 2024

Record last verified: 2024-02

Locations

TW(1)