UMIN-CTR Clinical Trial

Basic information
Public title	Effects of test food on lipid metabolism
Acronym	Effects of test food on lipid metabolism
Scientific Title	Effects of test food on lipid metabolism
Scientific Title:Acronym	Effects of test food on lipid metabolism
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to examine effects of test food on lipid metabolism.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Expired-gas measurement (lipid oxidation, carbohydrate oxidation, respiratory quotient)
Key secondary outcomes	Serum free fatty acid concentration, pulse rate (oxidative stress-antioxidant potential, concentration of serum lipid metabolites and hormones, oxygen consumption, and serum T-cho, LDL-Cho, HDL-Cho, TG and Glucose concentration)

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Food
Interventions/Control_1	Oral ingestion of the test food for two weeks
Interventions/Control_2	Oral ingestion of the placebo food for two 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

Eligibility
Age-lower limit	30 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	1) Individuals aged 30-59 years. 2) Individuals who are healthy (BMI >=18.5 and <30). 3) Individuals who can visit an inspection facility and be inspected in designated days. 4) Individuals who can pedal the cycle ergometer for more than 30 minutes. 5) Individuals who don't have regular exercise more than twice a week now or in the past 6 months. 6) Individuals whose written informed consent has been obtained.
Key exclusion criteria	1) Individuals who take foods more than three times a week with functional claims or foods or supplements containing Passienol-TM now or in the past 1 month, or will take them for this test period. 2) Individuals who take medications more than three times a week now or in the past 1 month, or will take them for this test period. 3) Individuals who take food for specified health use or foods with functional claims or supplements claiming to improve lipid metabolism more than three times a week now or in the past 1 month, or will take them for this test period. 4) Individuals who are allergic to especially foods or medicines or rubber. 5) Individuals who have currently or a history of hepatopathy, kidney damage, heart disease, lung, and gastrointestinal disease. 6) Individuals who were hospitalized in the past 6 months, or will be hospitalized for this test period. 7) Individuals who are currently treating anemia. 8) Individuals who are expected to have severe menstrual pain at one of the three cycle ergometer tests. 9) Females who are or are possibly pregnant, or are lactating. 10) Individuals who are a smoker. 11) Individuals who are heavy drinker of alcohol. 12) Individuals who have irregular life rhythms such as shift workers and late-night workers. 13) Individuals who participated in other clinical studies in the past 4 weeks, or will participate for this test period. 14) Individuals who donated total more than 200mL whole blood or blood component for the past 1 month. 15) Males who donated total more than 400mL whole blood for the past 3 months. 16) Females who donated total more than 400mL whole blood for the past 4 months. 17) Males who will donate total more than 1200mL blood for the past 12 months and this test period. 18) Females who will donate total more than 1200mL blood for the past 8 months and this test period. 19) Individuals judged inappropriate for this study by the principal investigator.
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Hiroko Middle name Last name Uchida
Organization	MORINAGA & CO., LTD.
Division name	Health Science and Research Center, R&D institute
Zip code	230-8504
Address	2-1-1, Shimodueyoshi, Tsurumi-ku, Yokohama
TEL	045-571-6140
Email	h-uchida-ji@morinaga.co.jp

Public contact
Name of contact person	1st name Naoko Middle name Last name Matsui
Organization	MORINAGA & CO., LTD.
Division name	Health Science and Research Center, R&D institute
Zip code	230-8504
Address	2-1-1, Shimodueyoshi, Tsurumi-ku, Yokohama
TEL	045-571-6140
Homepage URL
Email	n-matsui-ah@morinaga.co.jp

Sponsor
Institute	Morinaga & Co., Ltd
Institute
Department

Funding Source
Organization	Morinaga & Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	4F Sanwauchikanda Building, 3-3-5 Uchikanda, Chiyoda-ku, Tokyo
Tel	03-5297-3112
Email	IRB@cpcc.co.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	2020 Year 09 Month 15 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	12
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	Main results already published
Date of protocol fixation	2020 Year 08 Month 12 Day
Date of IRB	2020 Year 08 Month 21 Day
Anticipated trial start date	2020 Year 08 Month 24 Day
Last follow-up date	2020 Year 12 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	2020 Year 08 Month 30 Day
Last modified on	2021 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047494