UMIN-CTR Clinical Trial

Public title

How to Increase Short-Chain Fatty Acids, the Ace of Gut Environment - Development of Exercise Prescriptions -

Acronym

How to Increase Short-Chain Fatty Acids, the Ace of Gut Environment - Development of Exercise Prescriptions -

Scientific Title

How to Increase Short-Chain Fatty Acids, the Ace of Gut Environment - Development of Exercise Prescriptions -

Scientific Title:Acronym

How to Increase Short-Chain Fatty Acids, the Ace of Gut Environment - Development of Exercise Prescriptions -

Region

Japan

Condition

Healthy young adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We tested whether aerobic exercise for 3 months increases short-chain fatty acids in the gut in young subjects.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Concentrations of short-chain fatty acids, Gut microbiota of composition

Key secondary outcomes

Body composition, Quadriceps muscle strength, Cardiorespiratory fitness, Daily physical activity levels (the number of steps, brisk walking time), Nutrient intake

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Subjects in the BW group were instructed to take at least 8,000 steps daily, including at least 20 minutes of brisk walking at an intensity of 5 METs or more for 12 weeks.

Interventions/Control_2

Subjects were instructed to walk at least 8,000 steps at normal speed daily for 12 weeks.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

30

years-old

>

Gender

Male and Female

Key inclusion criteria

Healty sedentary young adults

Key exclusion criteria

subjects with arrhythmia, history of ischemic heart disease, chronic heart failure, hypertension (with systolic BP more than 160 mmHg or diastolic BP more than 100 mmHg), and chronic disease such as diabetes, renal dysfunction or neuropsychiatric disorder.
The subjects judged to be inappropriate for enrolled to exercise program.

Target sample size

30

Name of lead principal investigator

1st name	Emiko
Middle name
Last name	Morita

Organization

Aino University

Division name

Physical Therapy

Zip code

567-0012

Address

4-5-4 Higashioda Ibaraki city, Osaka

TEL

072-627-1711

Email

e-morita@pt-u.aino.ac.jp

Name of contact person

1st name	Emiko
Middle name
Last name	Morita

Organization

Aino University

Division name

Physical Therapy

Zip code

567-0012

Address

4-5-4 Higashioda Ibaraki city, Osaka

TEL

072-627-1711

Homepage URL

Email

e-morita@pt-u.aino.ac.jp

Institute

Faculty of Health Science, Department of Physical Therapy, Aino University

Institute

Department

Personal name

Organization

Grant-in-Aid for Scientific Research (KAKENHI)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Aino University

Address

4-5-4 Higashioda Ibaraki city, Osaka

Tel

072-627-1711

Email

e-morita@pt-u.aino.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2024

Year

05

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

30

Results

20 minutes of brisk walking per day at an intensity equivalent to or greater than 5 METs may increase the amount of acetic acid, a type of short-chain fatty acid, via Bifidobacterium, an acetic acid-producing bacterium.

Results date posted

2024

Year

02

Month

24

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

The study targeted 30 young adults in their twenties who were healthy and had no exercise habits.

Participant flow

Subjects were assigned to either BW group or CT group. Subjects in the BW group were instructed to take at least 8,000 steps daily, including at least 20 minutes of brisk walking at an intensity of 5 METs or more for 12 weeks. Subjects in the CT group were instructed to walk at least 8,000 steps at normal speed daily for 12 weeks.

Adverse events

None

Outcome measures

We assessed short-chain fatty acids concentration and the composition of the intestinal microbiota in fecal samples. We also assessed body composition, quadriceps muscle strength, the daily physical activity using an accelerometer, and cardiorespiratory fitness by the incremental shuttle walking test.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

Date of protocol fixation

2021

Year

06

Month

11

Day

Date of IRB

2021

Year

06

Month

11

Day

Anticipated trial start date

2021

Year

09

Month

01

Day

Last follow-up date

2025

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2024

Year

02

Month

24

Day

Last modified on

2024

Year

08

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061275

Single case data URL

Value
https://center6.umin.ac.jp/ice/61275