UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035055
Receipt number 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 12:41:54

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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 or person

Institute

Meiji Co., Ltd.

Institute

Department

Personal name



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

Value
https://center6.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