UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035055
Receipt No. R000039311
Scientific Title The effects of dietary high-protein yogurt on protein absorption in healthy adult men
Date of disclosure of the study information 2019/05/31
Last modified on 2019/06/04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The effects of dietary high-protein yogurt on protein absorption in healthy adult men
Acronym The effects of dietary high-protein yogurt on protein absorption
Scientific Title The effects of dietary high-protein yogurt on protein absorption in healthy adult men
Scientific Title:Acronym The effects of dietary high-protein yogurt on protein absorption
Region
Japan

Condition
Condition Healthy adult males
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We randomly allocated twelve subjects to administer either the high-protein yogurt or the control unfermented dairy products to investigate the postprandial blood amino acid level, followed by a washout period. These subjects were then crossed over and received the alternative dairy products.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the blood amino acid areas under the curve (AUC) (total amino acids, essential amino acids, leucine, BCAA)
Key secondary outcomes the maximum (Cmax) blood amino acid level (total amino acids, essential amino acids, leucine, BCAA)
Blood amino acid level at each blood collection time point (total amino acids, essential amino acids, leucine, BCAA)
the time to maximum concentration (Tmax) of amino acids (total amino acids, essential amino acids, leucine, BCAA)

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Single dose administration of 100 g of the high protein yogurt in intervention period
Interventions/Control_2 Single dose administration of 200 mL of the control unfermented dairy product in control period
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
20 years-old <=
Age-upper limit
30 years-old >
Gender Male
Key inclusion criteria 1) All subjects voluntarily signed the informed consent after detailed description and understanding of this study
2) 20-30 year old men
3) Subjects with BMI within normal range (18.5 kg/m2 =< BMI < 25.0 kg/m2)
Key exclusion criteria 1) Those who were administered ''drug'', such as H2 blocker, PPI, or digestive enzyme preparation, ''medicated products'', such as stomach medicine or digestive drugs, or ''supplement'' containing amino acids or protein, which may have effects on the protein absorption, within one month before the first administration of intervention or control food, or during this study.
2) Patients with diabetes mellitus
3) Patients with diseases or symptoms undergoing treatments
4) Those who may suffer from food allergy
5) Those who may suffer from lactose intolerance
6) Those who have smoking habits
7) Those who donated 200 mL or 400 mL of blood within one month or three months before giving written informed consent, respectively
8) Those who were included other clinical trials within one month before the first administration of intervention or control food, or during this study.
9) Any other medical and/or health reasons unfavorable to participation in this study, as judged by the principal investigator.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Shukuko
Middle name
Last name Ebihara
Organization Chiyoda para medical care clinic
Division name Chiyoda para medical care clinic
Zip code 101-0047
Address Chushin build 3-3-5 Uchikanda, Chiyodaku, Tokyo 101-0047, Japan
TEL 03-5297-5548
Email m.n@cpcc.co.jp

Public contact
Name of contact person
1st name Takaya
Middle name
Last name Kitamura
Organization Meiji Co., Ltd.
Division name R&D Total Oversight Department, R&D Division
Zip code 192-0919
Address 1-29-1 Nanakuni, Hachiouji, Tokyo 192-0919
TEL 042-632-5807
Homepage URL
Email takaya.kitamura@meiji.com

Sponsor
Institute Meiji Co., Ltd.
Institute
Department

Funding Source
Organization Meiji 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 Meiji Institutional Review Board
Address 1-29-1 Nanakuni, Hachiouji, Tokyo 192-0919
Tel 042-632-5900
Email MEIJI.IRB@meiji.com

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 チヨダパラメディカルケアクリニック
Chiyoda Paramedical Care Clinic

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 31 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
1. The changes in AUC (delta AUC0-180) and Cmax (delta Cmax) of the blood essential amino acid concentrations after the consumption of the high-protein yogurt were higher than the control unfermented dairy products (p<0.1, and p<0.05, respectively).

2. The changes in AUC (delta AUC0-180) and Cmax (delta Cmax) of the blood branched-chain amino acid (BCAA) and leucine concentrations after the consumption of the high-protein yogurt were higher than the control unfermented dairy products (both p<0.05).
Results date posted
2019 Year 06 Month 04 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
none
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 10 Month 12 Day
Date of IRB
2018 Year 10 Month 11 Day
Anticipated trial start date
2018 Year 10 Month 20 Day
Last follow-up date
2018 Year 11 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 28 Day
Last modified on
2019 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039311

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.