UMIN-CTR Clinical Trial

Basic information
Public title	The effects of pre-exercise high and low glycaemic index meals on metabolism and appetite
Acronym	Effects of pre-exercise different glycaemic index meals on metabolism and appetite
Scientific Title	The effects of pre-exercise different glycaemic index meals on glucose and fat metabolism, and appetite
Scientific Title:Acronym	Effects of pre-exercise different glycaemic index meals on subsequent metabolism and appetite
Region	Japan

Condition
Condition	Adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to investigate the effects of pre-exercise meal with high and low glycaemic index (GI) on carbohydrate metabolism, fat metabolism, appetite-related hormones and appetite in middle-aged inactive women
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fat oxidation
Key secondary outcomes	Expired gas, blood lipid and carbohydrate parameters, hormonal markers and food reward

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food Other
Interventions/Control_1	Participants consume the low GI meal and then perform walking exercise. Energy metabolism, blood lipids/carbohydrate metabolic parameters, hormonal markers and reward-driven appetite are measured and evaluated.
Interventions/Control_2	Participants consume the high GI meal and then perform walking exercise. Energy metabolism, blood lipids/carbohydrate metabolic parameters, hormonal markers and reward-driven appetite are measured and evaluated.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	30 years-old <=
Age-upper limit	59 years-old >=
Gender	Female
Key inclusion criteria	1. Age between 30 and 59 years old 2. Not taking any medications and dietary supplements 3. No medical and surgical diseases 4. No smoker 5. A participant who not performed weight changes plus or minus 3 kg in the past three months and who has no intention to weight loss during the study 6. Must not be the participant of others research within the research period (confirm by asking the participants directly and orally when explaining the research content) 7. A participant who can consume the test meal in the study 8. A participant whose menstrual cycle is normal
Key exclusion criteria	1. Not age between 30 and 59 years old 2. A participant who takes medications and dietary supplements 3. A participant who has medical and surgical diseases 4. Smoker 5. A participant who performed weight changes plus or minus 3 kg in the past three months and who has an intention to weight loss during the study 6. A participant who are scheduled to participate to others research. 7. A participant who cannot consume the test meal in the study 8. A participant who is pregnant, suspected of being pregnant, and within 1 year of parturition
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Masashi Middle name Last name Miyashita
Organization	Waseda University
Division name	Faculty of Sport Sciences
Zip code	359-1192
Address	2-579-15 Mikajima, Tokorozawa, Saitama
TEL	04-2947-6774
Email	m.miyashita@waseda.jp

Public contact
Name of contact person	1st name Masashi Middle name Last name Miyashita
Organization	Waseda University
Division name	Faculty of Sport Sciences
Zip code	359-1192
Address	2-579-15 Mikajima, Tokorozawa, Saitama
TEL	04-2947-6774
Homepage URL
Email	m.miyashita@waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

Funding Source
Organization	Waseda University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Waseda University
Address	1-104 Totsuka-cho, Shinjuku-ku, Tokyo
Tel	03-5272-1639
Email	rinri@list.waseda.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 11 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2021 Year 11 Month 15 Day
Date of IRB	2021 Year 11 Month 22 Day
Anticipated trial start date	2021 Year 11 Month 30 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 11 Month 27 Day
Last modified on	2022 Year 11 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052489