UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028612 |
|---|---|
| Receipt number | R000032737 |
| Scientific Title | The effect of protein supplementation at breakfast or supper for 12 weeks beyond habitual intakes on lean body mass and bone mineral density. |
| Date of disclosure of the study information | 2017/08/10 |
| Last modified on | 2019/02/12 19:13:41 |
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Basic information
Public title
The effect of protein supplementation at breakfast or supper for 12 weeks beyond habitual intakes on lean body mass and bone mineral density.
Acronym
The effect of protein supplementation at breakfast or supper for 12 weeks beyond habitual intakes on lean body mass and bone mineral density.
Scientific Title
The effect of protein supplementation at breakfast or supper for 12 weeks beyond habitual intakes on lean body mass and bone mineral density.
Scientific Title:Acronym
The effect of protein supplementation at breakfast or supper for 12 weeks beyond habitual intakes on lean body mass and bone mineral density.
Region
| Japan |
Condition
Condition
sarcopenia, osteoporosis
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to determine the effect of protein supplementation at breakfast and supper for 12 weeks beyond habitual intakes on lean body mass and bone mineral density in older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The following measures would be conducted before and after 12 weeks of intervention.
1) Lean body mass and bone mineral density
Key secondary outcomes
1) bone metabolism markers
2) myokine
3) clock-gene
4) Physical functional parameter
5) physical activity(accelerometer)
6) morningness-eveningness type, the center for epidemiologic studies depression scale, pittsburgh sleep quality index (questionaire)
Base
Study type
Interventional
Study design
Basic design
Parallel
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
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Breakfast (0600 - 1000): intake of milk protein 10 g/day for 12 weeks
Interventions/Control_2
Supper (1800 - 2200): intake of milk protein 10 g/day for 12 weeks
Interventions/Control_3
Breakfast placebo (0600 - 1000)
Interventions/Control_4
Supper placebo (1800 - 2200)
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Above 65 years older adults
2) Gives informed consent, agrees to be randomly assigned
Key exclusion criteria
1) Impaired cardiac (e.g., with cardiac pacemaker implants), kidney functions.
2) Physically active lifestyle
3) Intake of lipid and/or glucose lowering medication
4) Intake of Antipsychotics, Hypnotic, Steroids
5) Smoking habit
6) milk allergy
7) Phenylketonuria
8) Xylocaine allergy
9) Judged ineligible by a medical doctor.
10) History or presence of osteoporosis and compression fracture
11) Individuals with acute orthopedic pain and neurological symptom
12) Obesity (BMI>35kg/m2) and sleep apnea syndrome
13) High blood pressure (SBP:above140mmHg, and DBP:above 90mmHg)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigenobu Shibata |
Organization
Waseda University
Division name
Faculty of Science and Engineering
Zip code
Address
2-2 Wakamatsu, Shinjuku, Tokyo
TEL
03-5369-7318
shibatas@waseda.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hyeon-Ki Kim |
Organization
Waseda University
Division name
Organization for University Research Initiatives
Zip code
Address
2-2 Wakamatsu, Shinjuku, Tokyo
TEL
03-5369-7318
Homepage URL
hk.kim@aoni.waseda.jp
Sponsor or person
Institute
Waseda University
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
Meiji Co., Ltd, Tokyo Women's Medical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 08 | Month | 10 | 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
| 2017 | Year | 06 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 09 | Day |
Last modified on
| 2019 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032737
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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